Methods and systems for high throughput blood component collection

Abstract

Methods and apparatus for separating components from a multi-component fluid are provided. A method for collecting blood components includes: aspirating whole blood into a centrifuge; rotating the centrifuge to cause centrifugal force to act on the whole blood to separate the whole blood into at least a first blood component and a second blood component different from the first blood component; extracting a first blood component from the centrifuge; detecting when a second blood component is extracted from the centrifuge; and after detecting the second blood component and while the centrifuge continues to rotate, refluxing the separated first blood component toward the centrifuge to remove at least the second blood component from the centrifuge.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Patent Application No. 18 / 216,009, filed on June 29, 2023, and the benefit of U.S. Provisional Application No. 63 / 394,417, filed on August 2, 2022. The entire disclosure of the above application is incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to separation of components from a multi-component fluid, and in particular to apheresis methods and systems. Background Art

[0004] There are two common methods of donating / collecting blood. The first method is for a donor to donate whole blood, which is then subjected to a centrifugation process to separate blood components from the whole blood based on their density. During or possibly after the whole blood is subjected to the forces generated by the centrifuge, the desired components can be moved manually, semi-automatically, or automatically into a collection container. Another method may be apheresis, which requires a specialized machine.

[0005] The apheresis method extracts whole blood from a donor while the donor is connected to a dedicated machine. The whole blood can be centrifuged again to collect only the desired blood components (e.g., plasma), and all other unwanted blood components can then be returned to the donor during the same donation. 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 obtain a blood component donation. Therefore, making the donation process more efficient is a long-standing expectation of apheresis collection stations. Summary of the invention

[0006] There is a need for a plasma or other blood component system that can shorten the donation time and improve the comfort of the donor. The embodiments proposed herein improve the efficiency of the blood donation process by using the separated blood components to push or drive the unwanted blood components back to the donor without stopping and restarting the centrifuge. Therefore, the embodiments herein make the blood donation process more efficient and faster for the donor.

[0007] Embodiments may also provide methods and apparatus for positioning portions of a disposable in a medical device, such as a circuit. Embodiments may relate to the use of a surface for automated guidance of a circuit. In at least one exemplary embodiment, the medical device may be a blood separation machine, such as an apheresis machine.

[0008] Various aspects, implementations, and / or configurations of the present disclosure address the foregoing and other needs.In addition, although the present disclosure is presented in the form of exemplary implementations, it should be understood that the rights of various aspects of the present disclosure can be claimed separately.

[0009] In at least one exemplary embodiment, the present disclosure provides an assembly for separating components from a multi-component fluid. The assembly may include a filler including a channel for holding a separation capsule of a disposable, wherein the channel includes two opposing walls. The assembly may also include a loop rotation position guide, the loop rotation position guide including a plurality of bearings. When the separation capsule is loaded in the channel, the loop rotation position guide may maintain a flexible loop of the disposable.

[0010] In at least one exemplary embodiment, the circuit rotation position guide may include a stop plate. In at least one exemplary embodiment, the flexible circuit may contact the stop plate when the flexible circuit is retained in the circuit rotation position guide. In at least one exemplary embodiment, the assembly may form a portion of an apheresis machine. In at least one exemplary embodiment, the assembly may be connected to a rotor configured to rotate the circuit rotation position guide about a rotation axis. In at least one exemplary embodiment, the plurality of bearings may include a plurality of pairs of roller bearings.

[0011] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include: a centrifuge housing having an outer surface and an inner cavity, wherein the centrifuge housing rotates around the rotation axis of the centrifuge assembly; a fluid separation body, which is at least partially disposed in the inner cavity of the centrifuge housing and is configured to rotate relative to the centrifuge housing around the rotation axis; and a fluid pipeline loop arm, which is attached to a portion of the centrifuge housing and extends along the length of the outer surface of the centrifuge housing. The fluid pipeline loop arm may include a bearing group disposed at a point along the length of the outer surface. The bearing group may be configured to contact the pipe portion of the interconnected fluid pipeline loop and maintain the fluid pipeline loop in an engaged position relative to the centrifuge housing while allowing the fluid pipeline loop to rotate in the engaged position.

[0012] In at least one exemplary embodiment, the bearing set includes a pair of roller bearings. In at least one exemplary embodiment, the bearing set includes multiple pairs of roller bearings. In at least one exemplary embodiment, the centrifuge assembly can be part of an apheresis machine. In at least one exemplary embodiment, the fluid line loop can be fixed to a static non-rotating portion of the apheresis machine at a first end of the fluid line loop via a first positively located connector, and the fluid line loop can be interconnected with a fluid separation body in the inner cavity at a second end of the fluid line loop via a second positively located connector. In at least one exemplary embodiment, the second end of the fluid line loop can rotate with the fluid separation body. In at least one exemplary embodiment, the fluid line loop can be physically and fluidically attached to a disposable fluid separation capsule at the second positively located connector. In at least one exemplary embodiment, the fluid line loop may include multiple lumens, and the fluid separation capsule may include a first flexible sheet attached to a second flexible sheet forming a fluid path. The first portion of the fluid path can be narrow compared to the second portion of the fluid path.

[0013] In at least one exemplary embodiment, the present disclosure provides a method for automatically loading a fluid line loop into a centrifuge assembly. The method may include attaching a first end of the fluid line loop to a fluid separation body of the centrifuge assembly, and rotating the fluid separation body relative to the housing of the centrifuge assembly in a first rotational direction, wherein the rotating fluid separation body can rotate the fluid line loop relative to the housing and guide it into a channel of a loop arm attached to a portion of the housing. The channel may include a bearing disposed in a bearing group attached to the loop arm. When the centrifuge assembly rotates, the bearing can keep the fluid line loop in a position relative to the housing.

[0014] In at least one exemplary embodiment, the bearing may contact a portion of the fluid line loop when the fluid line loop rotates relative to the position of the housing within the channel. In at least one exemplary embodiment, the centrifuge housing may rotate about the rotation axis at a first angular velocity in a first rotational direction, and the fluid separation body may rotate about the rotation axis at a different second angular velocity by the torsional force provided by the fluid line loop. In at least one exemplary embodiment, the second angular velocity may be approximately twice the first angular velocity. In at least one exemplary embodiment, the fluid line loop may be physically and fluidically attached to a disposable fluid separation capsule that is at least partially disposed within the fluid separation body. In at least one exemplary embodiment, the method may further include attaching a second end of the fluid line loop to a rotational fixed point of the apheresis machine, and rotating the centrifuge assembly relative to the rotational fixed point of the apheresis machine around the rotational axis via a rotor and engine assembly of the apheresis machine.

[0015] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components by apheresis. The method may include: drawing whole blood from a blood donor into a centrifuge; rotating the centrifuge so that 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; and after detecting the second blood component and while the centrifuge continues to rotate, returning the separated first blood component toward the centrifuge to at least move the third blood component out of the centrifuge and return it to the blood donor.

[0016] In at least one exemplary embodiment, the first blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the second blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the third blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the first blood component may include two or more of plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, when separating the first blood component from whole blood, the centrifuge may rotate at a first speed. In at least one exemplary embodiment, when the separated first blood component flows back toward the centrifuge, the centrifuge may continue to rotate at the first speed. In at least one exemplary embodiment, when whole blood is drawn from a donor to the centrifuge, the centrifuge may rotate at a second speed. In at least one exemplary embodiment, the second speed may be slower than the first speed. In at least one exemplary embodiment, the first blood component may be separated from whole blood in a blood component collection device inserted into the centrifuge. In at least one exemplary embodiment, the centrifuge may include a filler that spins a blood component separation capsule associated with a blood component collection device. In at least one exemplary embodiment, the blood component separation capsule may be inserted into a separation insertion channel formed in the filler to hold the blood component separation capsule.

[0017] In at least one exemplary embodiment, the present disclosure provides a single blood collection system. The single blood collection system may include: a first conduit having a lumen fluidically associated with a needle and moving whole blood from a blood donor through the lumen; a suction pump coupled to the first conduit and sucking whole blood from the blood donor into a centrifuge; a centrifuge that rotates so that centrifugal force acts on the whole blood, thereby separating the whole blood into at least a first blood component and a third blood component; a blood component separation capsule that is inserted into the centrifuge and fluidically associated with the first conduit and separates the first blood component from the whole blood; and a second conduit that is fluidically associated with the blood separation capsule. The centrifuge includes a collecting container that is fluidly associated with the second conduit and that extracts the first blood component from the apheresis system; a sensor that is placed physically close to the second conduit to detect when the second blood component is extracted from the whole blood; and a return pump that is engaged with the second conduit and forces the separated first blood component to return through the second conduit toward the blood component separation bag after the sensor detects the second blood component and while the centrifuge continues to rotate, so as to remove at least a third blood component from the blood component separation bag and return it to the donor.

[0018] In at least one exemplary embodiment, the first blood component may include plasma and the second blood component may include platelets, red blood cells, high hematocrit blood, or a combination thereof. In at least one exemplary embodiment, the apheresis system may further include an anticoagulant pump configured to draw anticoagulant from an anticoagulant bag and mix the anticoagulant with whole blood at a manifold or junction fluidly associated with the first conduit. In at least one exemplary embodiment, the centrifuge may include a filler to rotate the blood component separation capsule. In at least one exemplary embodiment, the blood component separation capsule may be inserted into a separation insertion channel formed in the filler to hold the blood component separation capsule.

[0019] In at least one exemplary embodiment, the present disclosure provides a blood component collection device that can be associated with an apheresis system. The blood component collection device may include: a needle that is inserted into a blood vessel of a blood donor to aspirate whole blood from the blood donor; a first conduit that has a lumen that is fluidly associated with the needle and moves whole blood through the lumen, wherein an aspiration pump engaged with the first conduit aspirates whole blood from the blood donor; a blood component separation capsule that is inserted into a centrifuge and fluidly associated with the first conduit and separates a first blood component and a third blood component from the whole blood; a second conduit that is fluidly associated with the blood separation capsule and moves the first blood component out of the blood component separation capsule; and a collection container that is fluidly associated with the second conduit and extracts the first blood component from the apheresis system, wherein a sensor is placed in physical proximity to the second conduit to detect when the second blood component is extracted from the whole blood; and wherein, after the sensor detects the second blood component and while the centrifuge continues to rotate, a return pump engaged with the second conduit forces the separated first blood component back through the second conduit toward the blood component separation capsule to move at least the third blood component out of the blood component separation capsule and return it to the blood donor.

[0020] In at least one exemplary embodiment, the first blood component may include plasma and the second blood component may include platelets. In at least one exemplary embodiment, the suction pump may be disengaged when the return pump forces the separated first blood component back through the second conduit toward the blood component separation bag to remove at least a third blood component from the blood component separation bag and return it to the blood donor. In at least one exemplary embodiment, the blood component separation bag may be inserted into and held in a filler that rotates the blood component separation bag in a centrifuge. In at least one exemplary embodiment, the blood component separation bag may be inserted into a separation insertion channel formed in the filler to hold the blood component separation bag.

[0021] In at least one exemplary embodiment, the present disclosure provides a packing for holding a separation capsule in which a component is separated from a composite fluid. The packing may include a channel for holding the separation capsule during separation of the component from the composite fluid, the channel including a first wall and a second wall opposite to the first wall; and wherein a first end of the channel is adjacent to a central portion of the packing, and the channel spirals toward the periphery of the packing.

[0022] In at least one exemplary embodiment, the top of the channel can be narrower than the middle portion of the channel. In at least one exemplary embodiment, at least a portion of the second wall can have a concave surface. In at least one exemplary embodiment, the second end of the channel can be positioned so that it withstands higher gravity during separation than the first end. In at least one exemplary embodiment, the top of the channel can provide reinforcement to the separation capsule during separation.

[0023] In at least one exemplary embodiment, the present disclosure provides a fluid separation packing. The fluid separation packing may include a body having a rotation axis disposed approximately at the center of mass of the body and a fluid separation insertion channel disposed in the body and following a generally spiral path, the generally spiral path extending outwardly spirally from a first point adjacent to the rotation axis to a second point disposed adjacent to the periphery of the body, wherein the fluid separation insertion channel may jog outwardly toward the periphery of the body near an end of the generally spiral path, the end of the generally spiral path defining a third point at which the fluid separation insertion channel is disposed farthest from the rotation axis.

[0024] In at least one exemplary embodiment, the fluid separation filler may further include a fluid collection chamber disposed within the body and following a portion of the generally spiral path, wherein the fluid separation insertion channel is connected to the fluid collection chamber, defining an entry area between the interior of the fluid collection chamber and the exterior of the body. In at least one exemplary embodiment, the fluid collection chamber may be configured to receive a disposable fluid separation capsule. In at least one exemplary embodiment, the dimension from the axis of rotation to a third point of the generally spiral path may be greater than the dimension from the axis of rotation to a second point of the generally spiral path. In at least one exemplary embodiment, the width of the fluid collection chamber at a point along the generally spiral path may be greater than the width of the fluid separation insertion channel at a point along the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber may further include a first wall that follows the innermost portion of the generally spiral path and a second wall that is substantially parallel to the first wall and follows the outermost portion of the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber may further include one or more tapered walls disposed between the first wall and the second wall, and wherein the one or more tapered walls are configured to guide the disposable fluid separation capsule to a seated position within the fluid collection chamber. In at least one exemplary embodiment, when the disposable fluid separation capsule is installed in the fluid collection chamber, the fluid inlet for the disposable fluid separation capsule can be arranged adjacent to the rotation axis, and the first fluid path in the disposable fluid separation capsule can follow a generally spiral path outward toward the end of the third point of the disposable fluid separation capsule adjacent to the fluid separation insertion channel (set farthest from the rotation axis), and the first fluid path is fluidly interconnected with the second fluid path, which is separated from the first fluid path in the disposable fluid separation capsule and extends along the direction of the fluid outlet of the disposable fluid separation capsule set adjacent to the rotation axis starting from the third point and following the generally spiral path inward. In at least one exemplary embodiment, the fluid inlet and the fluid outlet can be part of a connector attached to the disposable fluid separation capsule, and wherein the body of the fluid separation filler can include a connection point that engages with the connector. In at least one exemplary embodiment, the connector can include at least one key feature, wherein the connection point includes at least one mating key feature, and wherein the key feature positively positions the connector relative to the connection point.

[0025] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include: a centrifuge housing having an inner cavity, wherein the centrifuge housing rotates around a rotation axis of the centrifuge assembly; and a fluid separation body, the fluid separation body at least partially disposed within the inner cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing around the rotation axis, wherein the fluid separation body includes a fluid separation insert channel disposed in the fluid separation body, the fluid separation insert channel following a generally spiral path, the generally spiral path extending spirally outward from a first point adjacent to the rotation axis to a second point disposed adjacent to the periphery of the fluid separation body, and wherein the fluid separation insert channel is offset outward toward the periphery of the body near an end of the generally spiral path, the end of the generally spiral path defining a third point at which the fluid separation insert channel is disposed farthest from the rotation axis.

[0026] In at least one exemplary embodiment, the fluid separation body may further include a fluid collection chamber disposed within the body and following a portion of a generally spiral path, wherein the fluid separation insert channel is connected to the fluid collection chamber to define an entry region between the interior of the fluid collection chamber and the exterior of the fluid separation body. In at least one exemplary embodiment, the centrifuge assembly may further include a disposable fluid separation capsule disposed within the fluid collection chamber following a generally spiral path, wherein the disposable fluid separation capsule includes a fluid inlet disposed adjacent to the axis of rotation, and a first fluid path in the disposable fluid separation capsule follows a generally spiral path outward toward an end of the disposable fluid separation capsule disposed in the fluid separation insert channel adjacent to a third point disposed farthest from the axis of rotation, and the first fluid path is fluidically interconnected with a second fluid path that is separated from the first fluid path in the disposable fluid separation capsule and extends in a direction from the third point following a generally spiral path inward toward a fluid outlet of the disposable fluid separation capsule disposed adjacent to the axis of rotation. In at least one exemplary embodiment, the centrifuge assembly may form part of an apheresis machine. In at least one exemplary embodiment, the centrifuge housing can be divided into an upper housing and a lower housing, wherein the upper housing can include an inner cavity, wherein the upper housing can be rotated between an open state and a closed state about a pivot axis, wherein the pivot axis is offset and substantially perpendicular to the rotation axis, and wherein a fluid separation insertion channel of the fluid separation body is accessible in the open state and inaccessible in the closed state.

[0027] In at least one exemplary embodiment, the present disclosure provides a blood component collection circuit. The blood component collection circuit may include a flexible circuit; a system static circuit connector, which is disposed at a first end of the flexible circuit, wherein the system static circuit connector is connected to a fixed circuit connector of a centrifuge to fix the first end of the flexible circuit so that it rotates synchronously with the centrifuge; a filler circuit connector, which is disposed at a second end of the flexible circuit opposite to the first end, wherein the filler circuit connector is connectable to a circuit connection area of ​​a filler, and wherein a torsional force based on torsion in the flexible circuit is applied to the filler through the filler circuit connector; and wherein the flexible circuit can be rotationally moved to be captured by a circuit rotation position guide positioned on the centrifuge.

[0028] In at least one exemplary embodiment, the blood component collection circuit can be part of a blood component collection device, and wherein the blood component collection device can be associated with a single collection system. In at least one exemplary embodiment, the loop rotation position guide can be attached to a rotor that rotates the loop rotation position guide and the flexible loop around an axis of rotation. In at least one exemplary embodiment, the blood component collection circuit can be positioned at least in part by a loop position stop plate. In at least one exemplary embodiment, the flexible loop can be bent around a centrifuge. In at least one exemplary embodiment, the flexible loop can also be held in place by a loop accommodating bracket. In at least one exemplary embodiment, at least a portion of the loop rotation position guide may include: a loop twist support bearing. In at least one exemplary embodiment, the loop twist support bearing may include a pair of roller bearings. In at least one exemplary embodiment, the loop twist support bearing may allow the flexible loop to twist. In at least one exemplary embodiment, twisting may cause the filler to rotate at a greater angular velocity than the centrifuge. In at least one exemplary embodiment, the flexible loop may include two or more lumens to move whole blood and / or blood components within the flexible loop.

[0029] In at least one exemplary embodiment, the present disclosure provides an assembly for loading a flexible circuit. The assembly may include: a circuit rotation position guide, the circuit rotation position guide including a channel for holding a flexible circuit of a blood component collection device; a circuit torsion support bearing, the circuit torsion support bearing is disposed in the channel and on a portion of the circuit rotation position guide to support the flexible circuit; and a circuit capture arm, wherein the circuit capture arm can be positioned at the vicinity of the channel and connected to the circuit rotation position guide to guide the flexible circuit into the channel and contact the circuit torsion support bearing.

[0030] In at least one exemplary embodiment, the assembly can be part of an apheresis machine, and wherein the circuit rotation position guide can be attached to a centrifuge that rotates the circuit rotation position guide and the flexible circuit about a rotation axis. In at least one exemplary embodiment, the circuit rotation position guide can also include a circuit position stop plate to further position the flexible circuit. In at least one exemplary embodiment, the assembly can also include a circuit containment bracket that is located in the same plane as the circuit rotation position guide and is disposed on the centrifuge to further capture the flexible circuit.

[0031] In at least one exemplary embodiment, the present disclosure provides a method for automatically loading a flexible loop into an assembly. The method may include connecting a system static loop connector disposed at a first end of the flexible loop to a fixed loop connector of a centrifuge to fix the first end of the flexible loop so that it rotates synchronously with the centrifuge; connecting a filler loop connector disposed at a second end of the flexible loop opposite to the first end to a loop connection area of ​​the filler, and wherein a torsional force based on torsion in the flexible loop is applied to the filler through the filler loop connector; and rotationally moving the flexible loop into a loop rotation position guide positioned on the centrifuge.

[0032] In at least one exemplary embodiment, the flexible loop can engage a loop torsion support bearing disposed in a channel formed by the loop rotational position guide, wherein the loop torsion support bearing supports the flexible loop. In at least one exemplary embodiment, the loop capture arm can contact the flexible loop when rotated to guide the flexible loop into the channel and contact the loop torsion support bearing. In at least one exemplary embodiment, the loop rotational position guide may further include a loop position stop plate to prevent the flexible loop from over-rotating through the channel. In at least one exemplary embodiment, a loop containment bracket located in the same plane as the loop rotational position guide and disposed on the centrifuge can further capture and retain the flexible loop.

[0033] In at least one exemplary embodiment, the present disclosure provides a soft box. The soft box may include a first box port; a second box port; a direct current lumen fluidically connected to the first box port and the second box port; a drip chamber, the drip chamber being disposed in the direct current lumen so that a fluid passing through the direct current lumen passes through the drip chamber; and a fluid flow bypass path, the fluid flow bypass path being fluidically connected to the direct current lumen adjacent to the first box port and between the first box port and the drip chamber, and being fluidically connected to the direct current body lumen adjacent to the second box port and between the second box port and the drip chamber, so that the fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0034] In at least one exemplary embodiment, the fluid flow bypass path may include: a first bypass branch, which is fluidically connected to the direct flow lumen adjacent to the first box port; and a second bypass branch, which is fluidically connected to the direct flow lumen adjacent to the second box port. In at least one exemplary embodiment, the fluid flow bypass path may also include a fluid pressure ring, which is disposed between the first bypass branch and the second bypass branch and is fluidically connected to the first bypass branch and the second bypass branch. In at least one exemplary embodiment, the direct flow lumen may include a first compliance region, which is disposed between the first connector with the first bypass branch and the drip chamber, allowing the first fluid control valve to close the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen may include a second compliance region, which is disposed between the second connector with the second bypass branch and the drip chamber, allowing the second fluid control valve to close the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen may include a third compliance region, which is disposed in the first bypass branch, allowing the aspiration fluid control valve to close the first bypass branch. In at least one exemplary embodiment, the first box port can be fluidly connected to a box inlet tube that moves fluid from a donor to a soft box or moves fluid from a soft box to a donor, and wherein the second box port can be fluidly connected to a loop inlet tube that moves fluid from a soft box to a centrifuge or moves fluid from a centrifuge to a soft box. In at least one exemplary embodiment, when fluid is drawn from a donor, the fluid can pass through a fluid flow bypass path. In at least one exemplary embodiment, when fluid is returned to a donor, the fluid can pass through a direct current lumen. In at least one exemplary embodiment, when fluid is drawn from a donor in a subsequent aspiration, a portion of the fluid previously delivered to the donor through the direct current lumen can remain in the drip chamber when the fluid passes through the fluid flow bypass path. In at least one exemplary embodiment, the soft box can be part of a blood component collection device. In at least one exemplary embodiment, the blood component collection device can be part of a single collection system.

[0035] In at least one exemplary embodiment, the present disclosure provides a blood component collection device. The blood component collection device may include: a centrifuge to separate blood components from whole blood; a box inlet tube, which is fluidly connected to a blood donor; a circuit inlet tube, which is fluidly connected to the centrifuge; a soft box, the soft box including a first box port fluidly connected to the box inlet tube, a second box port fluidly connected to the circuit inlet tube, a direct current lumen fluidly connected to the first box port and the second box port, a drip chamber, and a fluid flow bypass path, the drip chamber is arranged in the direct current lumen so that the fluid passing through the direct current lumen passes through the drip chamber, the fluid flow bypass path is fluidly connected to the direct current lumen adjacent to the first box port and between the first box port and the drip chamber, and is fluidly connected to the direct current lumen adjacent to the second box port and between the second box port and the drip chamber, so that the fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0036] In at least one exemplary embodiment, the fluid flow bypass path may include: a first bypass branch, the first bypass branch fluidly connected to the direct flow lumen adjacent to the first box port; a second bypass branch, the second bypass branch fluidly connected to the direct flow lumen adjacent to the second box port; and a fluid pressure ring, the fluid pressure ring is disposed between the first bypass branch and the second bypass branch and is fluidly connected to the first bypass branch and the second bypass branch. In at least one exemplary embodiment, the direct flow lumen may include a first compliance region, the first compliance region is disposed between the first connector with the first bypass branch and the drip chamber, allowing the first fluid control valve to close the direct flow lumen, wherein the direct flow lumen includes a second compliance region, the second compliance region is disposed between the second connector with the second bypass branch and the drip chamber, allowing the second fluid control valve to close the direct flow lumen, and wherein the direct flow lumen includes a third compliance region, the third compliance region is disposed in the first bypass branch, allowing the aspiration fluid control valve to close the first bypass branch. In at least one exemplary embodiment, when fluid is withdrawn from a donor, the first fluid control valve and the second fluid flow control valve close and seal the direct flow lumen, and the aspiration fluid control valve opens and allows whole blood to pass through the fluid flow bypass path. In at least one exemplary embodiment, when fluid is returned to the donor, the first fluid control valve and the second fluid flow control valve open and allow fluid to pass through the direct flow lumen, and the aspiration fluid control valve closes and seals the fluid flow bypass path. In at least one exemplary embodiment, when fluid is withdrawn from the donor in a subsequent withdrawal, a portion of the fluid previously delivered to the donor through the direct flow lumen can remain in the drip chamber as the fluid passes through the fluid flow bypass path.

[0037] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a softbox. The method may include: providing a softbox, wherein the softbox includes a first box port fluidly connected to a box inlet tube, a second box port fluidly connected to a circuit inlet tube, a direct current lumen fluidly connected to the first box port and the second box port, a drip chamber, and a fluid flow bypass path, wherein the drip chamber is disposed in the direct current lumen so that the fluid passing through the direct current lumen passes through the drip chamber, the fluid flow bypass path is fluidly connected to the direct current lumen adjacent to the first box port and located between the first box port and the drip chamber, and is fluidly connected to the second box port adjacent to the second box port and located between the second box port and the drip chamber a direct flow lumen so that fluid flowing through the fluid flow bypass path bypasses the drip chamber; when whole blood is drawn from a blood donor, whole blood is received from the cartridge inlet tube at a first cartridge port that is fluidly connected to the cartridge inlet tube; whole blood is moved to the second cartridge port through the fluid flow bypass path and the whole blood is prevented from moving through the direct flow lumen; and when red blood cells are returned to the blood donor, red blood cells are received from the circuit inlet tube at a second cartridge port that is fluidly connected to the circuit inlet tube, red blood cells are moved to the first cartridge port through the direct flow lumen and the drip chamber and the red blood cells are prevented from moving through the fluid flow bypass path.

[0038] In at least one exemplary embodiment, when fluid is drawn from a donor in a subsequent draw, as red blood cells are returned to the donor, a portion of the fluid previously returned to the donor through the direct flow lumen may remain in the drip chamber as the whole blood again passes through the fluid flow bypass path.

[0039] Any one or more aspects / embodiments substantially disclosed herein may optionally be combined with any one or more other aspects / embodiments substantially disclosed herein.

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

[0041] Depending on the particular aspects, embodiments, and / or configurations, the present disclosure can provide numerous advantages. By maintaining the rotational speed of the centrifuge while moving unwanted blood components back to the donor, the time of the apheresis process can be shortened, potentially by 30% or more. This increase in efficiency makes blood donations faster and more comfortable. With faster donation times, blood donation centers can receive more donations in a typical day, thereby increasing productivity and revenue. In addition, if blood donations are made faster, donors are more likely to donate again. Faster donations can also allow blood donation centers to attract donors who use other blood donation centers with slower donation times.

[0042] The phrases "at least one", "one or more", and "and / or" are open-ended expressions that are both conjunctive and discrete in operation. For example, each of "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" means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together.

[0043] The term "a" or "an" entity refers to 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.

[0044] As used herein, the term "donor" may refer to anyone who provides fluid (e.g., whole blood) to a single collection system. A donor may also be a patient who temporarily provides fluid to a single collection system, and the fluid is returned to the patient after being processed, treated, and / or manipulated.

[0045] As used herein, the term "automatic" and variations thereof refer to any process or operation that is performed without the need for human input that is considered substantial in the performance of that process or operation. However, even if a process or operation is performed with human input, whether substantial or insubstantial, the process or operation may still be automatic if the input is received prior to the performance of the process or operation. Human input is considered substantial if it affects the performance of the process or operation. Human input that consents to the performance of the process or operation is not considered "substantial."

[0046] As used herein, the term "computer-readable medium" refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. Such media can take a variety of forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, NVRAM or magnetic disks or optical disks. Volatile media include dynamic memory, such as main memory. Common forms of computer-readable media include, for example, floppy disks, floppy disks, hard disks, tapes or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tapes, any other physical media with hole patterns, RAM, PROMs and EPROMs, flash EPROMs, solid-state media (such as memory cards), any other memory chips or cassette memories, carriers as described below, or any other media from which a computer can read. Digital file attachments to emails or other self-contained information archives or archives are considered to be distribution media equivalent to tangible storage media. When the computer-readable medium is configured as a database, it should be understood that the database can be any type of database, such as a relational database, a hierarchical database, an object-oriented database, etc. Therefore, the disclosure is considered to include a tangible storage medium or distribution medium storing the software implementations of the disclosure and prior art-recognized equivalents and successor media.

[0047] The term "module" as used herein refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software capable of performing the functions associated with that element.

[0048] As used herein, the terms "determine," "calculate," and "compute" and variations thereof may be used interchangeably and include any type of methodology, process, mathematical operation or technique.

[0049] It should be understood that the term "means" as used herein should be given the broadest possible interpretation in accordance with 35 U.S.C. Section 112, paragraph 6. Therefore, claims involving the term "means" should cover all structures, materials, or acts set forth herein and all their equivalents. In addition, the structures, materials, or acts and their equivalents should include all that is described in the Summary of the Invention, the Description of the Figures, the Detailed Description, the Abstract, and the claims themselves.

[0050] The above is a brief overview of the present disclosure to provide an understanding of some aspects of the present disclosure. This overview is a neither extensive nor exhaustive overview of the present disclosure and its various aspects, embodiments and / or configurations. It is neither intended to identify the key or important elements of the present disclosure nor to describe the scope of the present disclosure, but rather to present the selected concepts of the present disclosure in a simplified form as an introduction to the more detailed description presented below. As will be understood, other aspects, embodiments and / or configurations of the present disclosure may utilize one or more features set forth above or described in detail below, alone or in combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 shows a perspective view of an operating environment of an exemplary apheresis system according to at least one exemplary embodiment of the present disclosure;

[0052] Figure 2A yes Figure 1 A perspective view of an exemplary apheresis system is shown;

[0053] Figure 2B According to at least one exemplary embodiment of the present disclosure, for example Figure 1 A perspective view of an exemplary pump for use with the exemplary apheresis system shown;

[0054] Figure 2C yes Figure 2B Another perspective view of the exemplary pump shown;

[0055] Figure 2D According to at least one exemplary embodiment of the present disclosure, for example Figure 1 A perspective view of an exemplary fluid valve control system for use with an exemplary apheresis system is shown;

[0056] Figure 3A According to at least one exemplary embodiment of the present disclosure, for example Figure 1 A perspective view of an exemplary disposable softbox assembly for use with an exemplary apheresis system is shown;

[0057] Figure 3B yes Figure 3A Another perspective view of the exemplary disposable softbox shown;

[0058] Figure 3C is along Figure 3B A vertical section view taken along line 3C in FIG.

[0059] Figure 3D is along Figure 3B The vertical section view taken by the line 3D;

[0060] Figure 4A According to at least one exemplary embodiment of the present disclosure, for example Figure 1A perspective view of an exemplary centrifuge assembly for use with the exemplary apheresis system shown;

[0061] Figure 4B yes Figure 4A A front perspective view of an exemplary centrifuge assembly shown in;

[0062] Figure 4C yes Figure 4A a rear perspective view of an exemplary centrifuge assembly shown in;

[0063] Figure 4D According to at least one exemplary embodiment of the present disclosure, Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0064] Figure 4E According to at least one exemplary embodiment of the present disclosure, the Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0065] Figure 4F According to at least one exemplary embodiment of the present disclosure, Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0066] Figure 4G According to at least one exemplary embodiment of the present disclosure, for example Figure 4A A perspective view of an exemplary packing for use with the exemplary centrifuge shown;

[0067] Figure 4H yes Figure 4G A plan view of an exemplary infill shown;

[0068] Fig. 4I According to at least one exemplary embodiment of the present disclosure, for example Figure 4G A schematic plan view of an exemplary generally spiral receiving channel for use with the exemplary filler shown;

[0069] Figure 4J is along Figure 4H A vertical sectional view taken along line 4J;

[0070] Figure 4K yes Figure 4G a detailed cross-sectional view of a portion of a channel in an exemplary filler shown;

[0071] Figure 4L Shows the settings in Figure 4G Different states of fluid separation bladders inside channels in the exemplary packing shown;

[0072] Figure 5A For example, according to an embodiment of the present disclosure, Figure 1 A schematic diagram of an exemplary fluid component collection device for use with an exemplary apheresis system shown;

[0073] Figure 5B yes Figure 5A An elevational view of an exemplary fluid component collection circuit is shown;

[0074] Figure 5C According to at least one embodiment of the present disclosure, for example Figure 5A A cross-section of an exemplary bladder of an exemplary fluid component collection circuit is shown;

[0075] Figure 5D According to at least one embodiment of the present disclosure, for example Figure 5A A cross-section of another exemplary bladder of an exemplary fluid component collection circuit is shown;

[0076] Figure 5E is a curved state according to at least one exemplary embodiment of the present disclosure Figure 5A A perspective view of an exemplary fluid component collection circuit is shown;

[0077] Fig. 5F According to at least one exemplary embodiment of the present disclosure, Figure 5A A perspective view of an exemplary fluid component collection circuit is shown;

[0078] Figure 5G According to at least one exemplary embodiment of the present disclosure, a method of loading a Figure 4G The exemplary filler shown in Figure 5A A perspective view of an exemplary fluid component collection circuit is shown;

[0079] Figure 5H According to at least one exemplary embodiment of the present disclosure, a method of loading a Figure 4G The exemplary filler shown in Figure 5A A perspective view of an exemplary fluid component collection circuit is shown;

[0080] Fig. 6A According to at least one exemplary embodiment of the present disclosure, the first circuit loading process state is Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0081] Figure 6B According to at least one exemplary embodiment of the present disclosure, the second loop loading process state is Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0082] Figure 6C According to at least one exemplary embodiment of the present disclosure, the third loop loading process state is Figure 4A A schematic cross-sectional view of an exemplary centrifuge assembly is shown;

[0083] Fig. 7A According to at least one exemplary embodiment of the present disclosure, the circuit loading is completed. Figure 4A A schematic plan view of an exemplary centrifuge assembly is shown;

[0084] Figure 7B is an operational state according to at least one exemplary embodiment of the present disclosure Figure 4A A schematic plan view of an exemplary centrifuge assembly is shown;

[0085] Figure 8 According to at least one exemplary embodiment of the present disclosure Figure 1 A functional diagram of an exemplary apheresis system is shown;

[0086] Fig. 9 According to at least one exemplary embodiment of the present disclosure Figure 1 A block diagram of an exemplary electrical system of an exemplary apheresis system is shown;

[0087] Fig.10 yes Fig. 9 Another block diagram of an exemplary electrical system is shown;

[0088] Fig.11 yes Fig. 9 Another block diagram of an exemplary electrical system is shown;

[0089] Fig.12 According to at least one exemplary embodiment of the present disclosure, for example, using Figure 1 A flowchart of an exemplary method for performing apheresis by the apheresis system shown;

[0090] Fig.13 According to at least one exemplary embodiment of the present disclosure, for example, using Figure 1 A flowchart of another exemplary method of performing apheresis by the apheresis system shown;

[0091] Fig.14 According to at least one exemplary embodiment of the present disclosure, for example, using Figure 1 A flowchart of another exemplary method of performing apheresis by the apheresis system shown;

[0092] Fig.15 According to at least one exemplary embodiment of the present disclosure, for example, using Figure 1 A flowchart of another exemplary method of performing apheresis by the apheresis system shown;

[0093] Fig.16 According to at least one exemplary embodiment of the present disclosure, a disposable article is inserted into a filler (such as Figure 4G A flowchart of an exemplary method of a filler as shown;

[0094] Fig.17A A single collection system (such as a single collection system) during a single collection procedure according to at least one exemplary embodiment of the present disclosure Figure 1 An exemplary functional diagram of a single collection system shown in FIG.

[0095] Fig. 17B A single collection system (such as a single collection system) during a single collection procedure according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0096] Fig. 17C A single collection system (such as a single collection system) during a single collection procedure according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0097] Fig.17D A single collection system (such as a single collection system) during a single collection procedure according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0098] Fig.17E A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0099] Fig.17F A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0100] Figure 17G A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0101] Fig.17H A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0102] Fig.17I A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1Another exemplary functional diagram of the apheresis system shown;

[0103] Fig.17J A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0104] Figure 17K A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0105] Figure 17L A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0106] Fig.17M A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0107] Fig.17N A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0108] Fig.17O A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0109] Figure 17P A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0110] Figure 17Q A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0111] Figure 17R A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0112] Figure 17SA single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0113] Figure 17T A single collection system (such as a single collection system) during a single collection process according to at least one exemplary embodiment of the present disclosure Figure 1 Another exemplary functional diagram of the apheresis system shown;

[0114] In the accompanying drawings, similar components and / or features may have the same reference numerals. In addition, for various components of the same type, similar components may be distinguished by adding a letter after the reference numeral. If only the first reference numeral is used in the specification, the description applies to any similar components having the same first reference numeral, regardless of the second reference numeral. DETAILED DESCRIPTION

[0115] Embodiments of the present disclosure will be described in conjunction with single collection methods and systems. The following embodiments may be described in terms of separating blood components from whole blood. However, this exemplary process is provided for illustrative purposes only. It should be noted that the embodiments are not limited to the following description. These embodiments are intended to be used for products, processes, devices and systems for separating any complex liquid. Therefore, the present disclosure is not limited to separating blood components from whole blood.

[0116] Figure 1 is a perspective view of an exemplary operating environment 100 of an exemplary apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 may include the apheresis system 200, a donor 102, and one or more connectors (e.g., a donor supply tube 104, a cartridge inlet tube 108A, and / or an anticoagulant tube 110) extending from the donor 102 to the apheresis system 200, and / or vice versa. For example, the donor supply tube 104 may be fluidly connected to at least one blood vessel (e.g., a vein) of the donor 102 via venipuncture. For example, a cannula connected to the end of the donor supply tube 104 may be passed through the skin of the donor 102 and inserted into a target site (e.g., a vein). Such a connection may provide an intravenous path for blood to flow from the donor 102 to the apheresis system 200, and / or for blood components to flow back to the donor 102. In at least one exemplary embodiment, the fluid path and connector may form an extracorporeal circuit of the apheresis system 200.

[0117] Blood supplied by the donor 102 may flow along the donor supply tube 104, through the tube connector 106, and along the box inlet tube 108A into the softbox assembly 300. The softbox assembly 300 may include one or more fluid control paths and valves for selectively controlling the flow of blood into and / or out of the donor 102. The apheresis system 200 may include a supply of anticoagulant contained in an anticoagulant (AC) bag 114. The anticoagulant may be pumped through at least the anticoagulant tube 110 and the tube connector 106 to prevent blood from clotting in the apheresis system 200.

[0118] Anticoagulants may include, but are not limited to, one or more of citrate and / or unfractionated heparin. The AC bags and other bags or bottles described herein may be made of, for example, but not limited to, one or more of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate copolymer (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The volume of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102, the volume flow of blood from the donor. In one embodiment, the volume in the AC bag 114 may be 250 mL to 500 mL, although the capacity of the AC bag 114 may be greater or less than this volume.

[0119] In at least one exemplary embodiment, the apheresis system 200 may include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or conduits 116, 120 (e.g., fluid delivery tubes) connecting the saline bag 118 and the plasma collection bottle 122 to an extracorporeal circuit of the apheresis system 200. The amount of saline provided in the saline bag 118 may be, for example, approximately 500 mL to 800 mL, although the volume of the saline bag 118 may be greater or less than this volume. An exemplary donation of a blood component (e.g., plasma) may be 880 milliliters (mL). Thus, the plasma collection bottle 122 may hold at least this amount of plasma. In at least one exemplary embodiment, the plasma collection bottle 122 may include a connection point disposed at, adjacent to, or physically proximate to a substantially bottom-most portion of the plasma collection bottle 122 (e.g., such as Figure 2A 2, when the plasma collection bottle 122 is installed in the plasma collection bracket 232C). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 to receive and / or transport plasma. Providing the connection point at the bottom of the plasma collection bottle 122 can allow the plasma contained in the plasma collection bottle 122 to be moved out of the plasma tube 120 through the pipeline, as described herein, without trapping bubbles. In at least one exemplary embodiment, the plasma collection bottle 122 can be configured as a flexible bag, a rigid container, and / or other container, and therefore, the plasma collection bottle 122 is not limited to a bottle or a bottle-like container.

[0120] Figure 2A Shows Figure 1 2. Apheresis system 200 can provide a continuous whole blood separation process. In at least one exemplary embodiment, whole blood can be drawn from donor 102 and provided substantially continuously to a blood component separation device of apheresis system 200, where the blood can be separated into various components, and at least one of the blood components can be collected from apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components can be collected for subsequent use or returned to donor 102. Blood can be drawn from donor 102 and directed to a centrifuge of apheresis system 200 through an opening 220 in an access plate 224 of apheresis system 200. In at least one exemplary embodiment, tubes 104, 108A, 108B, 112, 116, 120 used in an extracorporeal circuit can collectively define a closed, sterile, and disposable system or blood component collection device, which can be further described below.

[0121] Examples of apheresis, plasmapheresis, and other separation systems that may be used with embodiments of the present disclosure, such as apheresis system 200, include but are not limited to SPECTRA Single collection system, Spectral sampling system and TRIMA Automated blood collection systems, all of which are manufactured by Terumo BCT in Lakewood, Colorado.

[0122] The operation of the various pumps, valves, and blood component separation devices or centrifuges may be controlled by one or more processors included in the apheresis system 200. The one or more processors may include, for example, a plurality of embedded computer processors as part of a computer system. The computer system may also include components that allow a user to interact with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, and / or flash memory); communication / network devices (e.g., wired, such as a modem / network card; or wireless, such as Wi-Fi); input devices, such as a keyboard, touch screen, camera, and / or microphone; and output devices, such as a display and / or audio system. In order to assist the operator of the apheresis system 200 in operating the various methods, an embodiment of the blood component separation device or centrifuge may include a graphical user interface having a display, the display including an interactive touch screen.

[0123] The apheresis system 200 may include a housing 204 and / or structural frame, a cover 210, an access plate 224 disposed at the front 202 and / or rear 206 of the apheresis system 200, and one or more supports 232A-C (including hooks, brackets, brackets, arms, protrusions, plates, and / or other support structures for holding, supporting, and / or otherwise supporting bags or containers 114, 118, 122. In at least one exemplary embodiment, the coordinate system 103 and / or one or more axes in the coordinate system may be described. Features of the apheresis system 200. The housing 204 may include a machine frame (e.g., made of welded, bolted, and / or connected structural elements, extruded materials, and / or beams) to which one or more panels, covers 210, doors, subassemblies, and / or assemblies are attached. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may include a mounting surface for a softbox assembly 300, one or more pumps 208, 212, 216, and / or a fluid valve control system 228 (e.g., plasma and saline valve controls).

[0124] The access panel 224 may include one or more handles, locks, and pivot or articulated shafts 226 (e.g., door hinges, piano hinges, continuous hinges, and / or clean room hinges). In any case, the access panel 224 may be selectively opened to provide access to the interior of the apheresis system 200, and more specifically, to the blood separation assembly or centrifuge. In at least one exemplary embodiment, the access panel 224 may provide access to a centrifuge having one or more assemblies for loading and / or unloading at the blood component collection device.

[0125] The interior of the single collection system 200 can be divided into at least a centrifuge portion and a control portion. For example, the centrifuge portion may include a cavity configured to receive a centrifuge, a rotating motor, and related hardware. The area can be physically separated from the control portion by one or more walls of the cavity. In at least one exemplary embodiment, access to the control portion (e.g., configured to accommodate or otherwise contain a motor controller, a CPU or processor, electronic devices, and / or wiring) can be provided by a firmly fixed panel of the housing 204 and / or a plate separated from the access plate 224.

[0126] In at least one exemplary embodiment, the apheresis system 200 may include a plurality of pumps 208, 212, 216 configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulants, and / or saline) through the apheresis system 200. For example, the apheresis system 200 may include an aspiration pump 208 that controls the flow of blood to and / or from the donor 102 into a centrifuge of the apheresis system 200. The aspiration pump 208 may be coupled to a portion of a circuit inlet tube 108B disposed between the softbox assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 may include a return pump 212 configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to the plasma collection bottle 122 and / or from the plasma collection bottle to the centrifuge. Additionally or alternatively, the return pump 212 can control the flow of saline (e.g., saline supplied from the saline bag 118) through the blood component collection device and / or the apheresis system 200. The anticoagulant pump 216 can be coupled to a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant through the blood component collection device of the apheresis system 200. Figure 2A As shown, the pumps 208 , 212 , 216 can be at least partially disposed on the top cover 210 of the apheresis system 200 .

[0127] Figure 2B and Figure 2C Various perspective views of pumps 208, 212, 216 of apheresis system 200 are shown in accordance with at least one exemplary embodiment of the present disclosure. Figure 2B and Figure 2C An aspiration pump 208 is shown and described, but it should be understood that the other pump components of the apheresis system 200 (ie, the return pump 212 and the anticoagulant pump 216) may include substantially similar, if not identical, structure to the described aspiration pump 208.

[0128] 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 at least one exemplary embodiment, the pump cover 236 may include a hinged pipe guard 240 configured to open and close about a pipe guard pivot axis 242. In at least one exemplary embodiment, the pipe guard 240 may be attached to the pump cover 236 via one or more fasteners disposed along the pipe guard pivot axis 242. Figure 2B and Figure 2CAs shown, blood provided by donor 102 can be delivered or aspirated into the centrifuge along a first aspiration or centrifugation 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 along a donor direction 250B opposite to centrifuge direction 250A.

[0129] In at least one exemplary embodiment, 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 manipulate fluid (e.g., blood, blood components, anticoagulants, and / or saline) in at least a portion of 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 loop inlet tube 108B, the loop outlet tube 112, and / or the anticoagulant tube 110) can be inserted into the guide tube guide 244, the tube pressure block 248, and the end tube guide 252 adjacent to the rotating tube contact head. In at least one exemplary 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, or vice versa. The rotating tube contact head may include a plurality of rotating pressure rollers 268, which are configured to rotate around corresponding pressure roller rotation axes 264. Each rotating pressure roller 268 may be disposed between first and second rotating pump plates 272A, 272B, wherein plates 272A, 272B are configured to rotate about pump rotation axis 260. In at least one exemplary embodiment, rotating pressure rollers 268 may be disposed at the periphery of rotating pump plates 272A, 272B.

[0130] One or more of the pumps 208, 212, 216 may include, but are not limited to, Model UX-74130 peristaltic pump, MEC-O-MATIC series pumps, or similar operation thereto, all of which are manufactured by Pulsafeeder, Inc. of Punta Gorda, Florida. Other examples of pumps 208, 212, 216 may include, but are by no means limited to, INTEGRA DOSE IT laboratory peristaltic pumps manufactured by INTEGRA Biosciences AG, Switzerland, and WELCO WP1200, WP1100, WP1000, WPX1 and / or WPM series peristaltic pumps, all manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0131] Once the tubing is loaded into the guide tube guide 244, the tube pressure block 248, and / or the end tube guide 252, at least some of the rotating pressure rollers 268 may be brought into engagement, contact, or otherwise compressed with the tubing 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 may compress the portion of the tubing between the pumps 208, 212, 216 and the tube pressure block 248, thereby causing the fluid within that portion of the tubing to move positively in a particular direction 250A, 250B as the rotating pressure rollers 268 move. For example, as the rotating pump plates 272A, 272B rotate in a counterclockwise direction about the pump rotation axis 260, the rotation of the rotating pressure rollers 268 compresses the tubing between the rotating pressure rollers 268 and the tube pressure block 248, thereby causing the fluid to move or pump in the centrifugal direction 250A. As another embodiment, as the rotating pump plates 272A, 272B rotate in a clockwise direction around the pump rotation axis 260, the rotation of the rotating pressure roller 268 compresses the pipe between the rotating pressure roller 268 and the tube pressure block 248, thereby moving or pumping the fluid along the donor direction 250B. When not actively pumping, the pump 208 can remain in a state where at least one rotating pressure roller 268 continues to close the pipe 108B or remains in a state where there is no rotating pressure roller 268 closing the pipe 108B. Therefore, based on the state at rest, the pump 208 can also act as a "valve" to prevent or allow fluid movement. Pumps 212 and 216 may also have this capability.

[0132] The tube guard 240 and pump cover 236 can be used to protect an operator (e.g., a phlebotomist and / or phlebotomy technician) and / or a donor 102 from accidental contact with one or more moving parts of the pumps 208, 212, 216. In at least one exemplary embodiment, the tube guard 240 can be maintained in a closed position via one or more guard closure features 254 disposed in the tube guard 240, the guide tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In some cases, these guard closure features 254 can be magnets contained in the tube guard 240, the guide tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In at least one exemplary embodiment, when the tube guard 240 is open, the pumps 208, 212, 216 can be stopped or prevented from moving / operating. In at least one exemplary embodiment, a guard closure sensor can be included in the guard closure feature 254, the guides 244, 252, and / or the tube pressure block 248.

[0133] One or more fluid control valves may be used to control the route or flow direction of fluids conveyed through tubing of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 may include a plasma and saline valve control system 228 disposed adjacent to the saline bag 118 and / or the plasma collection bottle 122. The plasma and saline valve control system 228 may be configured to control the flow of fluids conveyed through tubing of the apheresis system 200. Figure 2D is shown in a detailed perspective view.

[0134] like Figure 2D As shown, the circuit outlet tube 112 can pass through the reflux pump 212 and interconnect with the saline and plasma tube y-shaped connector 280. The saline and plasma tube y-shaped connector 280 can allow the circuit outlet tube 112 to be connected to the saline tube 116 pipeline and the plasma tube 120 pipeline. The plasma and saline valve control system 228 may include an air detection sensor 284, which is disposed at the first end of the saline and plasma valve housing 276 and surrounds a portion of the circuit outlet tube 112. For example, the air detection sensor 284 can be any optical, ultrasonic or other type of sensor that can detect the presence of fluid or air in the circuit outlet tube 112 and provide the signal to the controller of the apheresis system 200. The type of air detection sensor 284 may include, for example, the SONOCHECK ABD05 manufactured by SONOTEC USA, or other similar sensors.

[0135] The saline and plasma valve housing 276 may include a plurality of receiving features (e.g., grooves, channels, and / or receiving slots) that receive a portion of the tubes 112, 116, 120 and / or the saline and plasma tube y-connector 280. Upon detecting air in the circuit 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 at least one exemplary embodiment, the detection of air via the air detection sensor 284 may be used to indicate an operating step and / or trigger a step in a control method as described herein.

[0136] 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 clamp valve, a tubing valve, and / or other actuatable valves configured to selectively alter (e.g., block) a fluid passage associated with a particular portion of the tubes 112, 116, 120. Figure 2DAs shown, the plasma flow control valve 286 can be configured to clamp the portion of the plasma tube 120 at least partially contained within the receiving feature of the saline and plasma valve housing 276. The saline flow control valve 288 can be configured to clamp the portion of the saline tube 116 at least partially contained within the receiving feature of the saline and plasma valve housing 276. In any case, the control valves 286, 288 can include an actuatable extendable finger that moves from a retracted or partially retracted position to an extended or partially extended position to clamp the portion of the tube contained within the saline and plasma valve housing 276. Although the control valves 286, 288 can fully clamp the tubing (e.g., fully restrict fluid flow therethrough), it should be understood that the control valves 286, 288 can be partially actuated to a position that partially restricts fluid flow through a portion of the tubing.

[0137] Figure 3A An exemplary disposable softbox assembly 300 according to at least one exemplary embodiment of the present disclosure is shown. The softbox assembly 300 may include a base plate and a box access door 304, which is attached to the base plate by at least one hinge and / or a box access door latch 308. In at least one exemplary embodiment, the box access door 304 can be unlocked by actuating the box access door latch 308 and pivoted about the box access door hinge axis 306. The softbox assembly 300 may be configured with one or more softbox receiving features 324 for at least partially accommodating and / or positioning a softbox 340 therein. The softbox 340 may be part of a blood component collection device as described herein. For example, the softbox 340 may be disposed between the box inlet tube 108A and the circuit inlet tube 108B of the extracorporeal tubing. In at least one exemplary embodiment, the softbox 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 to the donor.

[0138] The soft cartridge assembly 300 may include an air detection sensor 312, a fluid sensor 316, and one or more fluid control valves 320A to 320C configured to control the route or flow direction of the fluid through the soft cartridge 340. In at least one exemplary embodiment, these components may be embedded in a portion of the cartridge access door 304, the base plate, and / or the housing 204 of the apheresis system 200. Similar to the combination Figure 2B to Figure 2C In addition to the protective closure features 254 described above, the soft box assembly 300 may include one or more door closure features 328. These features 328 may include, but are not limited to, magnetic snaps, protrusions, tabs and slots, and / or other connectors. In at least one exemplary embodiment, the door closure features 328 may include a pressure contact surface configured to hold or at least partially position the soft box 340 within the soft box assembly 300.

[0139] Examples of valves 320A to 320C may include, but are by no means limited to, solenoid valves, linear actuators, pinch valves, wafer valves, pipe valves, and / or other actuatable valves configured to selectively change (e.g., close) a fluid passage (e.g., cross-sectional area) connected to a particular portion of the soft cartridge 340. The soft cartridge assembly 300 may include a first fluid control valve 320A configured to clamp a portion of the soft cartridge 340 adjacent to the cartridge inlet tube 108A. The second fluid control valve 320B may be configured to clamp a portion of the soft cartridge 340 adjacent to the circuit inlet tube 108B. The suction fluid control valve 320C may be configured to clamp a portion of the soft cartridge 340 along a branch tube extending from a point adjacent to the cartridge inlet tube 108A to a point adjacent to the circuit inlet tube 108B. In any case, the valves 320A-320C 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 a soft cartridge 340 included in the soft cartridge assembly 300. Although the valves 320A-320C may completely clamp a flow path in the soft cartridge 340 (e.g., completely block fluid flow therethrough), it should be understood that the valves 320A-320C may be partially actuated to a position that partially restricts fluid flow through a portion of the soft cartridge 340.

[0140] The sensors 312, 316 may be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, and the like. In some cases, the fluid sensor 316 may determine whether there is fluid in the softbox 340 based on the position of the magnet relative to the portion of the softbox 340. For example, when a portion of the softbox 340 is filled with fluid, the magnet may be disposed at a first position away from the surface of the softbox 340. On the other hand, when a portion of the softbox 340 is filled with air, the force from the magnet may compress the portion of the softbox 340 to a second position closer to the surface of the softbox 340 than the first position. In any case, the detection of air or fluid by the air detection sensor 312 and the fluid sensor 316, respectively, may be used to indicate an operating step and / or trigger a step in the control method as described herein.

[0141] FIG. 3B to FIG. 3DAn exemplary soft box 340 according to at least one exemplary embodiment of the present disclosure is shown. As described above, the soft box 340 can be part of a blood component collection device. For example, the soft box 340 can be a disposable component used in the blood separation method described herein. In at least one exemplary embodiment, the soft box 340 can be made of a substantially compliant and / or flexible material. The compliant material can be chemically inert and / or able to withstand sterilization and cleaning operations, temperatures and / or treatments. The soft box 340 can be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene-vinyl acetate copolymer (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In at least one exemplary embodiment, the soft box 340 can be molded, rotomolded, cast, injection molded, or otherwise formed by one or more of the above materials.

[0142] Soft box 340 can comprise the first box port 360A, the second box port 360B and the direct current lumen 370 extending between the first box port 360A and the second box port 360B.In at least one exemplary embodiment, the first box port 360A and / or the second box port 360B can be configured to receive and / or fluidly connect one or more tubes of blood component collection device.For example, the first box port 360A can be connected with box inlet pipe 108A, and the second box port 360B can be connected with loop inlet pipe 108B.These couplings can be airtight and / or fluid-tight.In at least one exemplary embodiment, the first box port 360A and / or the second box port 360B can comprise the hole arranged in the soft box 340, and the hole is configured to stretch elastically around the end of pipe (for example box inlet pipe 108A and / or loop inlet pipe 108B).

[0143] Blood supplied by the donor 102 can be directed along one or more fluid paths disposed within the soft cartridge 340. In at least one exemplary embodiment, blood can be directed from the first cartridge port 360A to the second cartridge port 360B along the direct flow lumen 370. In at least one exemplary embodiment, the flow path can direct blood through the drip chamber 354 of the soft cartridge 340. In at least one exemplary embodiment, blood and / or other fluids returned to the donor 102 can be directed from the second cartridge port 360B to the first cartridge port 360A along the direct flow lumen 370.

[0144] The soft box 340 may include a fluid flow bypass path provided by a first bypass branch 358A having a bypass lumen 364 that is fluidly connected to or as part of a portion of the direct flow lumen 370 adjacent to the first box port 360A. In at least one exemplary embodiment, the bypass lumen 364 may extend from a point of the direct flow lumen 370 adjacent to the first box port 360A along the first bypass branch 358A, through the fluid pressure ring 362 to the second bypass branch 358B, and reconnect to the direct flow lumen 370 at a point adjacent to the second box port 360B, or as part of the second box port 360B. As the name implies, the bypass lumen 364 provides a flow path within the soft box 340 that bypasses the drip chamber 354.

[0145] Controlling the flow path within the soft-cartridge 340 or directing the fluid within the soft-cartridge 340 may include actuating the fluid control valves 320A-320C of the soft-cartridge assembly 300 to interact with the various compliance regions 350A-350C that close and / or open portions of the direct flow lumen 370 and / or the bypass lumen 364. The first compliance region 350A provides a pinch valve region at a point along the direct flow lumen 370 between the first cartridge port 360A and the drip chamber 354 near the first cartridge port 342 of the soft-cartridge 340. When the first fluid control valve 320A is actuated, the valve 320A may pinch the direct flow lumen 370 closed at the first compliance region 350A, thereby limiting or completely preventing the flow of fluid at that point in the soft-cartridge 340. The second compliance region 350B provides a pinch valve region at a point along the direct flow lumen 370 between the second cartridge port 360B and the drip chamber 354 near the second cartridge end 346 (e.g., opposite the first cartridge port 342). When the second fluid control valve 320B is actuated, the valve 320B can clamp the direct flow lumen 370 at the second compliance region 350B to close it, thereby limiting or completely preventing the flow of fluid at this point in the soft cartridge 340. It is understood that the third compliance region 350C disposed adjacent to the fluid pressure ring 362 along the first bypass branch 358A can provide a pinch valve region at a point along the bypass lumen 364. When the aspiration fluid control valve 320C is actuated, the valve 320C can clamp the bypass lumen 364 at the third compliance region 350C to close it, thereby limiting or completely preventing the flow of fluid through the bypass lumen 364.

[0146] like Figure 3CThe direct flow lumen 370 extends from the first cartridge port 360A through the lumen volume 374 of the drip chamber 354 to the second cartridge port 360B as shown in the elevational cross-sectional view taken through a plane passing through the direct flow lumen 370 and the drip chamber 354. The direct flow lumen 370 can form a fluid passage extending within the first tube segment 368A, the lumen volume 374, and the second tube segment 368B of the soft cartridge 340.

[0147] In at least one exemplary embodiment, the bypass path of the soft box 340 may include a fluid pressure ring 362 through which the fluid can flow from the first bypass branch 358A to the second bypass branch 358B, and / or vice versa. In at least one exemplary embodiment, the pressure diaphragm 380 can be formed of the material of the soft box 340 within the fluid pressure ring 362 or in an area adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and the pressure diaphragm 380 are formed in a fluid pressure ring 362. Figure 3D , which is taken through a plane passing through the fluid pressure ring 362 and a portion of the first bypass branch 358A and the second bypass branch 358B. The pressure diaphragm 380 can provide a contact or measurement surface for the fluid sensor 316 to detect whether the fluid pressure ring 362 and / or the bypass lumen 364 include a certain amount of fluid, air, and / or a combination thereof. As described above, when the fluid fills a portion of the fluid pressure ring 362 compared to when air fills the fluid pressure ring 362, the fluid can provide greater resistance to movement. This resistance difference can be measured via the fluid sensor 316 to determine the amount and / or type of fluid (e.g., air and / or blood) in the bypass lumen 364 and / or the fluid pressure ring 362.

[0148] FIG. 4A to FIG. 4C An exemplary centrifuge assembly 400 for use with a single collection system 200 according to at least one exemplary embodiment of the present disclosure is shown. The centrifuge assembly 400 can be disposed in an interior space of the single collection system 200. The interior space can be at least partially surrounded by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the interior space and the centrifuge assembly 400 can be provided via an access plate 224 disposed at the front 202 of the single collection 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 clean room hinge, and / or some other panel hinge.

[0149] Centrifuge assembly 400 is operably mounted within apheresis system 200 such that assembly 400 is rotatable relative to housing 204 and / or other components of apheresis system 200. By placing tubing (e.g., loop inlet tube 108B and / or loop outlet tube 112) (e.g., via Figure 2AThe centrifuge assembly 400 may be loaded with one or more parts of a blood component collection device by introducing the opening 220 shown in the figure into the interior space of the apheresis system 200, connecting a portion of the blood component collection circuit 520 to the fixed circuit connector 402, and inserting the blood component separation capsule 536 into the filler 460. The fixed circuit connector 402 holds the circuit inlet tube 108B and the circuit outlet tube 112 in a fixed position and can prevent the tubes 108B, 112 from twisting outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection circuit 520 can be interconnected with the fixed circuit connector 402 via one or more keying features or positive positioning features.

[0150] The centrifuge assembly 400 may include a centrifuge split housing 404 including a lower housing 404A pivotally connected to an upper housing 404B. The upper housing 404B may be opened to provide access to load a blood component separation bag or other components of a blood component collection device into the centrifuge assembly 400. In at least one exemplary embodiment, the upper housing 404B may be rotated about a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, and / or with bolts).

[0151] Different halves of the centrifuge split housing 404 (e.g., lower housing 404A and 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 the centrifuge rotation axis 430. Although in FIG. 4B to FIG. 4C 4B is shown in an unlocked state, but it should be understood that the upper housing 404B can be rotated about the centrifuge rotation axis 430 (e.g., in a counterclockwise rotation direction) to engage one or more locking tabs 428 or elements of the upper housing 404B with the locking grooves 432 provided in the lower housing 404A (e.g., Figure 4C 4B). When in the unlocked position, the upper housing 404B can be opened or pivoted about the split housing pivot axis 406 to load the blood component collection circuit 520 and / or the blood component separation capsule 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 lock synchronously during centrifuge or blood separation operations.

[0152] The centrifuge assembly 400 may include at least one clockwise rotation stop 408A, a counterclockwise rotation stop 408B, an upper housing clockwise rotation flag 410A, and / or an upper housing counterclockwise rotation flag 410B. In at least one exemplary embodiment, the rotation stops 408A, 408B may be rotationally fixed relative to the centrifuge rotation axis 430 of the lower housing 404A. The rotation flags 410A, 410B may be attached to or formed in the upper housing 404B and configured to contact the corresponding rotation stops 408A, 408B to prevent the upper housing 404B from over-rotating relative to the lower housing 404A when the two halves of the centrifuge split housing 404 are locked and / or unlocked together. For example, when the upper housing 404B rotates in a clockwise or unlocked direction about the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation mark 410A can contact the clockwise rotation stop 408A, preventing further rotation in the clockwise direction. Additionally or alternatively, when the upper housing 404B rotates in a counterclockwise or locked direction about the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation mark 410B can contact the counterclockwise rotation stop 408B, preventing further rotation in the counterclockwise direction. In at least one exemplary embodiment, the centrifuge split housing 404 may include one or more locking elements that are configured to maintain the half of the centrifuge split housing 404 in a locked state when the locking elements are engaged.

[0153] In at least one exemplary embodiment, the centrifuge split housing 404 may include a pull ring 412 attached to a portion of the upper housing 404B to enable the upper housing 404B to pivot relative to the lower housing 404A about the split housing pivot axis 406. The pull ring 412 may provide a hole through which a user may insert a finger and apply a pulling force to the rotationally unlocked upper housing 404B.

[0154] The centrifuge assembly 400 may include a rotor and a motor assembly 414 controlled and / or powered via an electrically interconnected cable 420. The cable 420 may include a connector attached to a controller, a processor, and / or a power supply. The cable 420 may transmit power and / or data signals between the rotor and the motor assembly 414 and one or more controllers / processors of the single collection system 200. The rotor and motor assembly 414 may be configured as a motor and / or a portion of a motor to rotate the entire centrifuge assembly 400 relative to the single collection system 200 (e.g., relative to a portion of the housing 204 and / or the base of the single collection system 200). In other words, the rotor and motor assembly 414 may include one or more components that rotate the centrifuge assembly 400 (e.g., two halves of the centrifuge split housing 404 together) within the single collection system 200.

[0155] As described herein, the centrifuge assembly 400 may include one or more features to guide, contain, and / or position components of the blood component collection device relative to the centrifuge split housing 404. For example, Figure 4B , the blood component collection circuit 520 is shown captured in an operating position in a circuit rotation position guide 424 including a circuit capture arm 416. The circuit rotation position guide 424 may include a plurality of bearings 417 and / or bearing surfaces that are configured to at least partially support the blood component collection circuit 520 in the operating position. In the operating position, the blood component collection circuit 520 may be twisted along its length within the support provided by the bearings 417 of the circuit rotation position guide 424. For example, the blood component collection circuit 520 may be fixedly attached to the fixed circuit connector 402 of the apheresis system 200 at one end, while the other end of the blood component collection circuit 520 may be attached to a filler 460 (e.g., an internal rotating component of the centrifuge assembly 400). When the centrifuge assembly 400 rotates during centrifuge operation, the twisting of the blood component collection circuit 520 between the fixed circuit connector 402 and the connector at the filler 460 may cause the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In at least one exemplary embodiment, when the centrifuge assembly 400 rotates in the apheresis system 200, the low inertia of the filler 460 is coupled to the torsion of the blood component collection circuit 520, which may cause the filler 460 to rotate in the same rotational direction at twice the angular velocity of the centrifuge split housing 404. In this embodiment, when the centrifuge split housing 404 rotates in a counterclockwise direction around the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 may rotate in a counterclockwise direction within the centrifuge split housing 404 at a second angular velocity 2ω (e.g., substantially twice the first angular velocity).

[0156] The centrifuge assembly 400 may include one or more balancing features, elements, and / or structures disposed about the centrifuge axis of rotation 430 of the centrifuge assembly 400. These balancing features may provide an axially balanced centrifuge assembly 400 such that when rotating on the centrifuge axis of rotation 430, the centrifuge assembly 400 may not substantially vibrate the apheresis system 200. In at least one exemplary embodiment, a centrifuge balancing weight 418 may be attached to a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B). The centrifuge balancing weight 418 may be custom tuned for the centrifuge assembly 400 and may therefore be selectively attached to and removed from the centrifuge assembly 400. The tuning of the centrifuge balancing weight 418 may be calculated and / or empirically derived to produce a fully balanced centrifuge assembly 400, particularly when loaded with one or more elements of a blood component collection device.

[0157] Figure 4C 4B. A portion of the filler 460 can be seen through the hole in the upper housing 404B. The blood component collection circuit 520 is shown in an initial circuit loading position 520A, wherein the first end is interconnected with the filler 460 and the second end is fixedly attached to the fixed circuit connector 402 (not shown). The blood component collection circuit 520 is shown as passing through the circuit in the centrifuge split housing 404 into the gap 436. When the blood component collection circuit 520 is loaded in the circuit loading position 520A, a portion of the blood component collection circuit 520 can be partially accommodated, held and / or supported by the circuit accommodating bracket 426. The circuit accommodating bracket 426 may include one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings and / or combinations thereof) or bearing surfaces, which are arranged to at least partially support the blood component collection circuit 520 when the blood component collection circuit 520 is twisted relative to the centrifuge assembly 400. In at least one exemplary embodiment, the blood component collection circuit 520 can be rotated about an axis extending along the length of the flexible circuit 524 (e.g., in an installed or assembled condition and / or state) to allow the flexible circuit 524 to perform relative rotational movement relative to the circuit rotation position guide 424. For example, the circuit does not "twist up", but actually rotates or rolls between one or more bearings 417 relative to the circuit rotation position guide 424 (e.g., a support structure). Such rotation or torsion may be referred to herein as a twist without constraining or twisting the flexible circuit 524 upward. The twist allows the flexible circuit 524 to transmit rotational forces to the filler 460 without significantly reducing the inner diameter of the lumen of the flexible circuit 524. In some cases, the inner diameter of the lumen of the flexible circuit 524 is not reduced.

[0158] As described above, when the upper housing 404B is FIG. 4B to FIG. 4C When the rotational unlocked position shown is rotated to the rotational locked position, the locking tab 428 of the upper housing 404B can engage with the locking groove 432 of the lower housing 404A. Additionally or alternatively, when moved to the rotational locked position, the circuit accommodating bracket 426 can be rotated along the circuit engagement position 520B to a position in line with the circuit rotation position guide 424 together with the blood component collection circuit 520 and the upper housing 404B. In at least one exemplary embodiment, when the upper housing 404B and the blood component collection circuit 520 are rotated into the circuit engagement position 520B, the circuit capture arm 416 can guide the blood component collection circuit 520 into the bearing 417 and / or bearing surface of the circuit rotation position guide 424. This will be described below in conjunction with 6A to 7B The loading of the blood component collection circuit 520 is described in detail.

[0159] FIG. 4D to FIG. 4F Various cross-sectional schematic views taken through the center of the centrifuge assembly 400 (e.g., bisecting the centrifuge assembly 400 by the centrifuge rotation axis 430) are shown. As described above, the centrifuge assembly 400 may include a lower housing 404A 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 rotatably interconnected with an upper housing bushing block 442 attached to a pull ring 412. In at least one exemplary embodiment, a bearing 417, bushing, or bearing surface may be disposed between the upper housing adapter 440 and the upper housing bushing block 442, thereby allowing the upper housing 404B to rotate along the centrifuge rotation axis 430 from a locked position to an unlocked position, and vice versa. The pull ring 412 may be rotationally fixed relative to the lower housing 404A about the centrifuge rotation axis 430. In at least one exemplary embodiment, upper housing adapter 440 and upper housing 404B may be formed of a unitary structure.

[0160] The filler 460 can be fixedly attached to a filler spindle 434 that is configured to rotate relative to the upper housing 404B about the centrifuge rotation axis 430. In at least one exemplary embodiment, the filler spindle 434 can be formed by a portion of the filler 460. In any case, one or more spindle support bearings 444 can be disposed between the filler spindle 434 and the upper housing adapter 440, thereby allowing the filler 460 to rotate about the centrifuge rotation axis 430 within the centrifuge split housing 404 and the centrifuge assembly 400. In at least one exemplary embodiment, the filler spindle 434 can be retained in an operating position via at least one retaining nut 438. The filler 460 and the filler spindle 434 can rotate together relative to the centrifuge split housing 404.

[0161] Figure 4D The centrifuge assembly 400 is shown in a closed state (e.g., prior to loading the blood component collection circuit 520). Upon unlocking the upper housing 404B relative to the lower housing 404A, the operator can pull the pull ring 412 to pivot the entire upper housing 404B and filler 460 about the split housing pivot axis 406. In at least one exemplary embodiment, the upper housing 404B and filler 460 can be partially opened by pivoting the components about the split housing pivot axis 406 in an opening direction 446, as shown. Figure 4E As shown. Figure 4E4, wherein the centrifuge assembly 400 is shown in a partially open state, the upper housing 404B and the filler 460 rotate away from the lower housing rotation axis 430A. In this position, the filler 460 can be allowed to rotate around the filler rotation axis 430B. When the lower housing 404A and the upper housing 404B are in a closed state, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (coincided or substantially coincident) to form the centrifuge rotation axis 430.

[0162] Continue 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 ring 412), which can move the upper housing 404B and the filler 460 from Figure 4D The closed position shown is pivoted approximately 180 degrees. Figure 4F As shown, the centrifuge assembly 400 is in an open or loaded state. In this position, the upper housing 404B and the filler 460 can be pivoted outside the interior space of the single collection system 200. For example, at least a portion of the upper housing 404B and / or the filler 460 can be placed in the open space of the open access plate 224. In this position, the loading access area 450 can be provided to the circuit connection area 454 of the filler 460. It can be understood that the upper housing 404B is oriented in the open position to provide easy access to the interior of the upper housing 404B and the filler 460. Among other things, this arrangement can provide sufficient clearance for the operator to attach the blood component collection circuit 520 to the filler 460 at the circuit connection area 454.

[0163] Figure 4G A filler 460 is shown, such as a centrifuge assembly 400. In at least one exemplary embodiment, the filler 460 can be made of a lightweight material such as (plastic, carbon fiber and / or aluminum). In at least one exemplary embodiment, the filler 460 can be 3D printed via a three-dimensional (3D) printer. For example, the filler 460 can be produced via an additive manufacturing technology or system, such as fused deposition molding (FDM), selective laser sintering (SLS), stereolithography (SLA) and / or other additive manufacturing machines. Among other things, these additive rapid prototyping techniques can allow the filler 460 to have more complex geometries, which may not be achieved using conventional machining or manufacturing processes. In at least one exemplary embodiment, the material of the filler 460 can be selected based on the desired quality of the filler 460, the desired physical strength of the filler 460 to be manufactured and / or the appropriate material for manufacturing.

[0164] The filler 460 may include a circuit connection area 454 disposed approximately at the center of the filler 460. The circuit connection area 454 may include one or more keying or positive positioning features for engaging a portion of the blood component collection circuit 520. Figure 4G As shown, the circuit connection area 454 includes a first positive positioning feature 478 disposed along a portion of the central axis of the filler 460. The first positive positioning feature 478 may be a keyway, groove, slot, or other feature that engages with a mating feature disposed on the blood component collection circuit 520. In at least one exemplary embodiment, the filler 460 may include a second positive positioning feature 480 in the circuit connection area 454. The positioning features 478, 480 may prevent the blood component collection circuit 520 from rotating at the circuit connection area 454 and / or prevent the blood component collection circuit 520 from being disengaged from the circuit connection area 454 of the filler 460.

[0165] In at least one exemplary embodiment, the filler 460 may include a separation insert channel 466 that is configured to receive and at least partially accommodate a blood component separation capsule of a blood component collection device, and more specifically, the separation insert channel 466 is configured to receive and at least partially accommodate a blood component collection circuit 520. The separation insert channel 466 can be configured as a groove, a slot, that extends outward from the center of the filler 460 in a generally spiral manner. In at least one exemplary embodiment, the separation insert channel 466 can follow a generally spiral path that may include a first spiral path portion that extends outward from the center of the filler 460 along the length of the periphery of the separation insert channel 466 to a substantially constant radius (e.g., around the center of the filler 460). In any case, the path may be referred to herein as a spiral path or a generally spiral path. The separation insert channel 466 may begin at a channel entrance 468 adjacent to the center of the filler body 464 and terminate at a channel end 472 adjacent to the point farthest from the center of the filler body 464. As FIG. 4G to FIG. 4IAs shown, the separation insertion channel 466 can extend along a generally spiral path 490 extending from a point adjacent to the filler rotation axis 430B to the channel end 472. The generally spiral path 490 may include a channel path jog 476 at a point near or adjacent to the channel end 472. The channel path jog 476 can extend the separation insertion channel 466 a certain distance from the center of the filler body 464, thereby increasing the centripetal force and centrifugal force at the channel end 472 of the separation insertion channel 466. In at least one exemplary embodiment, the channel path jog 476 can correspond to the key inlet and outlet at the radial maximum within the blood component separation capsule 536, which is at least partially inserted or disposed within the separation insertion channel 466 of the filler 460. In at least one exemplary embodiment, the filler 460 may include one or more filler balancing protrusions 482 disposed on a portion of the filler body 464, disposed in the filler body 464, or around the filler body 46. These filler balancing protrusions 482 can provide axial balancing of the filler 460 (eg, about the filler rotation axis 430B), particularly when the separation insert channel 466 includes a blood component separation bladder and fluid (eg, blood, blood components).

[0166] Fig. 4I A generally spiral receiving channel or separation insertion channel 466 for a filler 460 is shown. The schematic plan view shows a first distance R1 of the separation insertion channel 466 from the center of the filler body 464 (e.g., adjacent to the filler rotation axis 430B) at a first point along the generally spiral path 490, and a second distance R2 of the separation insertion channel 466 from the center of the filler body 464 at a point adjacent to the adjacent channel path protrusion 476. Fig. 4I As shown, the second distance R2 is further away from the center of the filler body 464 than the first distance R1. This increase in distance can be at a point near or at the channel end 472, so that the centripetal and centrifugal forces within the channel are higher than at any other point along the generally spiral path 490. In at least one exemplary embodiment, the end of the blood separation capsule can substantially coincide with the channel end 472, thereby providing a maximum blood separation force at the end of the capsule.

[0167] Figure 4J to Figure 4LVarious elevational cross-sections of the filler 460 are shown, and more specifically, a separation insertion channel 466 and a filler insertion chamber 492 disposed within the filler body 464 are shown. In at least one exemplary embodiment, the separation insertion channel 466 may include a cross-section or shape that substantially follows a generally spiral path 490 in the filler body 464. The separation insertion channel 466 may include an insertion groove that is configured to receive a substantially flat or unfilled blood component separation capsule. The blood component separation capsule can be inserted into the separation insertion channel 466 and the filler insertion chamber 492 formed in the filler body 464 along the generally spiral path 490. The filler insertion chamber 492 can be defined by one or more side walls 494, 496 that form a cavity that follows the generally spiral path 490. As shown in FIG. Figure 4K As shown, the filler insertion chamber 492 includes an inner cavity wall 494 spaced a distance from at least one outer cavity wall 496. The filler insertion chamber 492 can be formed in the filler 460 by 3D printing the filler 460 and / or by some other metal or plastic forming operation (e.g., casting, molding, and / or forming). In at least one exemplary embodiment, the filler insertion chamber 492 may include one or more insertion guide features 498. These insertion lead-in features 498 may be configured to guide, position, and / or seat the blood component separation capsule 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 guide feature 498 may include one or more fillets, chamfers, bevels, tapers, draft angles, receiving grooves, grooves, and / or other forming materials configured to guide and / or orient a portion of the blood component separation capsule for insertion.

[0168] Figure 4LDifferent states of a fluid separation capsule (e.g., a blood component separation capsule) disposed within the separation insertion channel 466 and the filler insertion chamber 492 of the filler 460 are shown. As described above, the blood component separation capsule can be inserted into the separation insertion channel 466 in a substantially flat or unfilled state S1. In the substantially flat state S1, the blood component separation capsule can be sized to enter the upper opening of the separation 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 donor 102, the blood component separation capsule can expand from the substantially flat first state S1 to an expanded or filled state S2. In at least one exemplary embodiment, the blood component separation capsule can expand with the blood and / or blood components until the walls of the blood component separation capsule contact the walls 494, 496 of the filler insertion chamber 492. In at least one exemplary embodiment, the shape of the filler insertion chamber 492 can be designed to maximize the volume of fluid that can be collected and / or separated in the filler insertion chamber 492 (e.g., maximize the volume of fluid while minimizing the amount of material of the filler 460).

[0169] Figure 5A A blood component collection device 500 according to at least one exemplary embodiment of the present disclosure is shown. The blood component collection device 500 may include tubing (e.g., one or more of a donor supply tube 104, a cassette inlet tube 108A, a circuit inlet tube 108B, an anticoagulant tube 110, a circuit outlet tube 112, a saline tube 116, and / or a plasma tube 120, etc.), connectors (e.g., one or more of a tube connector 106, a saline and plasma tube y-connector 280, a tube fitting 504, a tube fitting 508, and / or a bag spike fitting 512), a soft cassette 340, and a blood component collection circuit 520.

[0170] The pipeline may include any tube having a central lumen configured to convey fluid therethrough. The tube may be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene-vinyl acetate copolymer (EVA), rubber, polymer, copolymer and / or a combination thereof. The connector may be configured to interconnect with the tube fluidly (e.g., at one or more ends of the pipeline). The connector may be inserted into the central lumen of the tube and / or connected to the outside of the tube. In at least one exemplary embodiment, the connector may be configured with various accessories (e.g., Luer fittings, twist connections and / or other small-bore couplings) to provide universal and / or reliable interconnection with one or more other accessories, connectors, tubes, needles and / or medical accessories. In at least one exemplary embodiment, the bag nail accessory 512 may be configured to be inserted into a receiving bag (e.g., a saline bag 118).

[0171] The blood component collection circuit 520 may include a flexible circuit 524 disposed between a system static circuit connector 528 and a filling circuit connector 532. The flexible circuit 524 may be configured as a hollow flexible tube configured to receive and / or contain at least a portion of the circuit inlet tube 108B and the circuit outlet tube 112. In at least one exemplary embodiment, the flexible circuit 524 may be made of a thermoplastic elastomer having enhanced flexibility for transferring torsion from one end of the flexible circuit 524 to the other end. These types of elastomers may provide the flexibility of rubber while maintaining the strength and torque properties of plastic. Examples of thermoplastic elastomers may include, but are not limited to, copolyesters, Dupont TM Thermoplastic elastomers, Eastman Neostar TM Elastomer, Celanese Elastomer, TOYOBO and / or other brands of elastomers that provide high flexibility and strength properties.

[0172] In at least one exemplary embodiment, the blood component collection circuit 520 may include a blood component separation capsule 536 having a capsule circuit end 540A and a capsule free end 540B. The blood component separation capsule 536 may include a first collection flow chamber 544 that is connected to the flexible circuit 524 at the filling circuit connector 532. In particular, fluid can flow between the circuit inlet tube 108B and the first collection flow chamber 544 via the flexible circuit 524 and the connectors 528, 532, and / or vice versa. Fluid flowing along the first collection flow chamber 544 in a direction from the capsule circuit end 540A to the capsule free end 540B can reach the flow chamber transition portion 548 and enter the second collection flow chamber 552. In at least one exemplary embodiment, the second collection flow chamber 552 is interconnected to the flexible circuit 524 at the filling circuit connector 532. In particular, fluid may flow between the circuit outlet tube 112 and the second collection flow chamber 552 via the flexible circuit 524 and connectors 528 , 532 , and / or vice versa.

[0173] Combination Figure 5BThe elevation view of Figure 5 shows details of the blood component collection circuit 520. The blood component collection circuit 520 may include a flexible circuit 524 configured as a tube including a first path for the circuit inlet tube 108B and a second path for the circuit outlet tube 112. In at least one exemplary embodiment, the circuit inlet tube 108B can pass through the flexible circuit 524 and interconnect with the first collection flow chamber 544 at the capsule circuit end 540A via the filler circuit connector 532. Additionally or alternatively, the circuit outlet tube 112 can pass through the flexible ring 524 and interconnect with the second collection flow chamber 552 at the capsule circuit end 540A via the filler circuit connector 532. The first path is separated from the second path. This configuration can allow blood to enter the flexible circuit 524 and the blood component separation capsule 536 via the first collection flow chamber 544 and be separated into one or more blood components, and then the blood components can be transported to the circuit outlet tube 112 in the flexible circuit 524 along the second collection flow chamber 552.

[0174] The first collection flow chamber 544 can be separated from the second collection flow chamber 552 via a flow chamber divider 542. The flow chamber divider 542 can be a heat-sealed portion of the blood component separation sac 536. For example, the blood component separation sac 536 can be made of material layers that overlap each other along the length of the blood component separation sac 536. The material layers can be formed (e.g., cut or otherwise formed) and heat-sealed along one or more edges to form a fluid container. The flow chamber divider 542 can be formed in the fluid container by heat-sealing one material layer to another material layer along a path generally shown in the figure. The flow chamber divider 542 does not extend over the entire length of the blood component separation sac 536, thereby providing a fluid chamber transition portion 548 for the fluid (e.g., blood, blood components) to flow from the first collection flow chamber 544 to the second collection flow chamber 552, and / or vice versa. In at least one exemplary embodiment, fluid (e.g., blood and / or blood components) contained in the blood component separation capsule 536 in the filler insertion chamber 492 of the filler 460 can travel along the first collection fluid chamber 544 in a direction toward the capsule free end 540B (e.g., along the blood component travel direction 546) around the end of the fluid chamber separator 542 and into the second collection flow chamber 552. In this embodiment, the blood components (e.g., plasma) can be forced back along the generally spiral path 490 through the second collection flow chamber 552 toward the center of the filler body 464 and through the circuit outlet tube 112 (e.g., to the plasma collection bottle 122).

[0175] The blood component separation bag 536 can be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate copolymer (EVA), thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In at least one exemplary embodiment, the blood component separation bag 536 can be formed by heat sealing multiple layers of material, by a single layer of material folded over itself, and / or combinations thereof.

[0176] In at least one exemplary embodiment, the blood component collection circuit 520 may include a plurality of positive positioning or key features 530A, 530B configured to positively position portions of the blood component collection circuit 520 relative to the apheresis system 200 and / or the filler 460. For example, the blood component collection circuit 520 includes a first connector position feature 530A on the system static circuit connector 528 and a second connector position feature 530B on the filler circuit connector 532. The features 530A, 530B may be configured as keys, tabs, and / or other material protrusions extending from the connectors 528, 532. In at least one exemplary embodiment, the second connector position feature 530B may include a feature that interconnects or mates with the first positive position feature 478 and / or the second positive position feature 480 of the circuit connection area 454 in the filler 460. Similarly (if not identical), the positive position feature may be associated with or included in the fixed circuit connector 402 of the apheresis system 200.

[0177] Figure 5C and Figure 5D A cross section of a blood component separation bladder 536 of a blood component collection circuit 520 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 separation bladder 536. In at least one exemplary embodiment, the separation can be provided by a flow chamber divider 542 disposed between the first collection flow chamber 544 and the second collection flow chamber 552. The flow chamber divider 542 can correspond to a sealed area of ​​the blood component separation bladder 536. The flow chamber divider 542 can be formed by a heat-sealed area of ​​material, for example, joining 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 one of the upper bladder seal 554A area or the lower bladder seal 554B area).

[0178] Figure 5D The cross section shown in may correspond to the blood component separation capsule 536 prior to sealing, and Figure 5CThe cross-section shown in FIG. 5 may correspond to the blood component separation bladder 536 after forming or sealing the upper bladder seal 554A, the lower bladder seal 554B, and / or the flow chamber divider 542 (e.g., welding the bladder first side material 536A to the bladder second side material 536B). Once formed, the width WB of the bladder may correspond to the width WB of the bladder in the unexpanded state S1 (see, e.g., Figure 4L ) of the first collection flow chamber 544 and / or the second collection flow chamber 552. During operation, as the fluid fills at least a portion of the blood component separation capsule 536, the size of the capsule width WB can be changed from Figure 5C . For example, the width WB of the bladder can be increased to approximately the size of the filler insertion chamber 492 of the filler 460. In at least one exemplary embodiment, the welds made when manufacturing the blood component separation bladder 536 (e.g., by RF and / or ultrasound) can be supported in the filler 460. In at least one exemplary embodiment, the top of the filler 460 supports the top two welds, and the bottom of the filler 460 supports the final weld.

[0179] FIG. 5E to FIG. 5H Various perspective views (eg, FIG. 5E to FIG. 5F ) and a view of the curved blood component separation bag 536 of the blood component collection circuit 520 being inserted into the filler 460 (eg Figure 5G to Figure 5H ). The various components of the blood component collection circuit 520 can be flexible and / or capable of being formed or shaped by the application of force. In at least one exemplary embodiment, the flexibility can be elastic so that the shaping of the various parts of the blood component collection circuit 520 does not permanently deform the components. Figure 5E The blood component collection circuit 520 is shown in a bent state. For example, the flexible circuit 524 is shown as being elastically bent along its length, and the blood component separation capsule 536 is shown as following a plurality of bends or curves along its length. When the component is in a bent state, the flexible circuit 524 can still deliver fluid provided via the circuit inlet tube 108B to the first collection flow chamber 544 of the blood component separation capsule 536, and vice versa. Additionally or alternatively, when the component is in a bent state, the flexible circuit 524 can deliver fluid from the second collection flow chamber 552 of the blood component separation capsule 536 to the circuit outlet tube 112, and vice versa.

[0180] In at least one exemplary embodiment, Fig. 5FAs shown in , the blood component collection circuit 520 can be pre-formed to fit within the separation insertion channel 466 of the filler 460. The pre-forming can include twisting the blood component separation bladder 536 of the blood component collection circuit 520 to match the generally spiral path 490 of the separation insertion channel 466. Once pre-formed, the features of the blood component collection circuit 520 can be aligned with one or more features of the filler 460, such as Figure 5G As shown. In at least one exemplary embodiment, the filler circuit connector 532 of the blood component collection circuit 520 can be aligned with the circuit connection area 454 of the filler 460 so that the second connector locating feature 530B is aligned to engage with the first positive locating feature 478. Additionally or alternatively, the blood component separation capsule 536 can be molded or formed (e.g., by hand) to match the generally spiral path 490 of the separation insertion channel 466 in the filler 460. In some cases, the molding or forming may include aligning the capsule free end 540B of the blood component separation capsule 536 with the channel end 472 of the separation insertion channel 466 in the filler 460. When the components are generally aligned with each other, the blood component collection circuit 520 can be moved in a direction toward the separation insertion channel 466 and the circuit connection area 454 (e.g., by hand). Figure 5G shown).

[0181] In at least one exemplary embodiment, the first positive positioning feature 478 can interconnect and / or retain the second connector positioning feature 530B of the filler circuit connector 532 of the blood component collection circuit 520 when the filler circuit connector 532 moves toward and into the circuit connection area 454 of the filler 460. The interconnection can prevent the filler circuit connector 532 from rotating relative to the filler 460. In some cases, the interconnection can retain the filler circuit connector 532 of the blood component collection circuit 520 within the circuit connection area 454 of the filler 460. Figure 5H A blood component collection circuit 520 is shown loaded in a filler 460 according to at least one exemplary embodiment of the present disclosure.

[0182] FIG. 6A to FIG. 6C A centrifuge assembly 400 is shown in various circuit loading states according to an embodiment of the present disclosure. FIG. 6A to FIG. 6C The centrifuge assembly 400 shown in FIG. 4 may correspond to the centrifuge assembly 400 described above, in particular in combination with FIG. 4D to FIG. 4F The centrifuge assembly 400 is described. Specifically, Fig. 6A A schematic cross-sectional view showing a first circuit loading state of the centrifuge assembly 400 is shown, Figure 6B A schematic cross-sectional view showing a second circuit loading state of the centrifuge assembly 400, and Figure 6CA schematic cross-sectional view of a second circuit loading state of the centrifuge assembly 400 is shown.

[0183] exist Fig. 6A , the centrifuge assembly 400 is shown in an open circuit loading position, wherein the upper housing 404B has been pivoted 180 degrees from the closed or operating position. The open position may correspond to Figure 4F The centrifuge assembly 400 is shown in FIG. Fig. 6A 4, the blood component collection circuit 520 has been inserted into the filler 460, and the filler circuit connector 532 is interconnected to the circuit connection area 454 of the filler body 464. The other end of the blood component collection circuit 520 is connected to the fixed circuit connection 402 via the system static circuit connector 528. In this first circuit loading state, the flexible circuit 524 is fixed to prevent rotation at the fixed circuit connection 402, but rotates synchronously with the filler 460 at the circuit connection area 454.

[0184] exist Figure 6B 4, the centrifuge assembly 400 is shown in a partially closed position, wherein the upper housing 404B is moving from an open position to a 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 rotationally fixed at the fixed loop connection 402, the filler 460 is free to rotate about the filler rotation axis 430B (e.g., only limited by the rotationally fixed flexible loop 524).

[0185] exist Figure 6C4, the centrifuge assembly 400 is shown in a closed or operating position, wherein the upper housing 404B can be locked to the lower housing 404A (so that the lower housing 404A and the upper housing 404B can rotate synchronously about the centrifuge rotation axis 430). In this position, the flexible loop 524 can pass from the loop connection area 454 of the filler 460 through the loop access gap 436 of the centrifuge split housing 404 to the fixed loop connection 402. In at least one exemplary embodiment, the flexible loop 524 can move freely within the loop access gap 436 while 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 loop 524 rotationally fixed at the fixed loop connection 402 can twist along the length of the flexible loop 524, thereby rotating the filler 460 within 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 a 2:1 ratio. For example, when the centrifuge assembly 400 rotates one revolution, the rotationally fixed flexible loop 524 (e.g., fixed to the fixed loop connection 402) twists at the loop connection area 454 (e.g., attempts to untwist from the rotation of the centrifuge assembly 400), thereby rotating the filler 460 in the same rotational direction as the centrifuge assembly 400, but approximately two revolutions. This rotation of the filler 460 by the flexible loop 524 twisting along its length does not require a gear transmission between the centrifuge assembly 400 and the filler 460.

[0186] FIG. 7A to FIG. 7B A schematic plan view of a centrifuge assembly 400 is shown that automatically loads a circuit into an operational position (eg, blood separation) for centrifugation. FIG. 7A to FIG. 7B The centrifuge assembly 400 shown in FIG. 4 may correspond to and / or be combined with the centrifuge assembly 400 as previously discussed. 4A to 4F and FIG. 6A to FIG. 6C Once the blood component collection circuit 520 has been loaded into the centrifuge assembly 400, as shown in FIG. Figure 6C As shown, the flexible loop 524 can be automatically loaded into the loop engagement position 520B, as shown in FIG. FIG. 7A to FIG. 7B shown.

[0187] In at least one exemplary embodiment, when the upper housing 404B is locked to the lower housing 404A, the flexible loop 524 can extend from the loop connection area 454 of the filler 460 to the fixed loop connector 402 of the apheresis system 200. Although the flexible loop 524 can be rotationally secured to the fixed loop connector 402 at the system static loop connector 528, the flexible loop 524 passing through the loop access gap 436 in the centrifuge split housing 404 may not initially be retained or at least partially captured by the loop rotation position guide 424 and / or other features of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop rotation position guide 424 or the loop arm can correspond to an uncaptured loop state 700A. In other words, the flexible loop 524 can be oriented at a certain angle α relative to the loop rotation position guide 424, the loop position stop plate 704, and / or one or more loop torsional support bearings 708 or bearing groups. In at least one exemplary embodiment, the loop torsional support bearing 708 can correspond to a combination of the loop rotation position guide 424 and the loop position stop plate 704. FIG. 4B to FIG. 4C The circuit receiving area or channel can be formed by the circuit position stop plate 704 and / or one or more circuit torsion support bearings 708 disposed along the length of the upper housing 404B. In at least one exemplary embodiment, the orientation can be designed to allow for the FIG. 6A to FIG. 6C The described circuits are accessible during loading and / or easy to load.

[0188] As the centrifuge assembly 400 rotates in the loop and filler rotation direction 712 about the centrifuge rotation axis 430, the flexible loop 524 may move from the uncaptured loop state 700A to the Figure 7B 700B. The rotation may be caused by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the circuit and filler rotation direction 712, and / or by the rotor and electrode assembly 414 rotating the centrifuge assembly 400 about the centrifuge rotation axis 430. In at least one exemplary embodiment, when the flexible circuit 524 rotates in the circuit and filler rotation direction 712, an outer portion of the flexible circuit 524 may contact a circuit position stop plate 704 or other rotation stop surface of the circuit rotation position guide 424.

[0189] When the flexible circuit 524 is held or at least partially contained in the circuit rotation position guide 424, a portion of the flexible circuit 524 can move within one or more of the circuit torsion support bearings 708. As described above, the flexible circuit 524 can be rotationally fixed to the fixed circuit connector 402 via the first connector positioning feature 530A of the system static circuit connector 528 associated with the blood component collection circuit 520. This rotationally fixed connection prevents the flexible circuit 524 from rotating relative to the apheresis system 200 at the fixed circuit connector 402. The other end of the flexible circuit 524 can be interconnected at the circuit connection area 454 of the filler 460, where the end can move with the filler 460 and / or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the circuit and filler rotation direction 712, the force from the flexible circuit 524 that attempts to disentangle or prevent adhesion causes the filler 460 and the end of the flexible circuit 524 attached thereto to rotate.

[0190] In any case, once the fluid separation methods described herein are completed, the centrifuge assembly 400 can be stopped from rotating and the centrifuge split housing 404 can be opened to remove the disposable elements of the blood component collection device 500 from the centrifuge assembly 400. In some cases, the flexible circuit 524 can be removed from the centrifuge assembly 400 by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the circuit and filler rotation direction 712. Figure 7B The captured loop state 700B shown moves to Fig. 7A An uncaptured loop state 700A is shown.

[0191] Figure 8 An exemplary functional diagram of the single collection system 200 is shown in FIG. Figures 1 to 7B The components described in are used to describe the operation of system 200 to extract plasma or other blood components from whole blood of donor 102 during an apheresis procedure or process.

[0192] The system 200 may include an anticoagulant (AC) pump 216. The AC pump 216 pumps fluid in the AC tube 110 from the AC bag 114. The AC pump 216, AC tube 110, and / or AC bag 114 may be as previously described. The AC tube 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tube 110. The AC ADS 804 may be the same or similar in type and / or function to the sensor 284 and / or sensor 312 described above. The AC tube 110 may intersect and fluidically associate with the donor supply tube 104 and the cassette inlet tube 108 at the tube connector 106. The tube connector 106 may be any type of connection between the tube 110, the tube 104, and / or the tube 108A, as previously described.

[0193] Donor supply tube 104 is connected from donor 102, wherein donor 102 can be penetrated by a lumen needle or other device to allow whole blood to flow from donor 102 into apheresis system 200 and allow blood components to flow back to donor 102. Tube 108A can be connected to soft box 340. In addition, donor air detection sensor 312 can be placed on or in tube 108A to detect the presence of fluid and / or air in tube 108A.

[0194] As previously described, the softbox 340 may include a first box port 360A, which may function as, include, and / or be substantially close to a "Y" shaped connector or segment or branch that separates the tube 108A into a first bypass branch 358A and a first tube segment 368A (the "Y" shaped segment will be indicated by reference numeral 360A). The two tube segments 358 and 368 may be reconnected at a second box port 360B, which may also function as, include, and / or be substantially close to a second "Y" shaped connector or segment (the second "Y" shaped segment will be indicated by reference numeral 360B). The tube 358 is bisected by the fluid sensor 316, which divides the tube 358 into a first bypass branch 358A and a second bypass branch 358B. Similarly, the tube 368 is bisected by the drip chamber 354, which divides the tube 368 into a first tube segment 368A and a second tube segment 368B.

[0195] The first pipe segment 368A may include a first fluid control valve 320A. The second pipe segment 368B may include a second fluid control valve 320B. 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 various sections 368A, 358A, 358B, and 368B of the pipe may be separated by valves 320A, 320B, and / or 320C.

[0196] The drip chamber 354 can be disposed between the first tube segment 368A and the second tube segment 368B. Depending on the operation of the apheresis system 100 as described below, the drip chamber 354 can collect a volume of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells). As previously described, the fluid sensor 316 can be disposed between the first bypass branch 358A and the second bypass branch 358B.

[0197] The circuit inlet tube 108B can be connected to the second cartridge port 360B and can connect the soft cartridge 340 to the flexible circuit 524. The circuit inlet tube 108B can also include a sensor 808 disposed on or in the tube 108B, which is placed with the tube 108B before connecting with the system static circuit connector 528 of the flexible circuit 524. The pressure sensor (CPS) 808 can detect (but is not limited to) one or more of the following: pressure, the presence of fluid or air, and / or possible other characteristics of the fluid in the tube 108B. In addition, the suction pump 208 can cause the fluid to be pumped out of the soft cartridge 340 or to the soft cartridge 340 through the tube 108B.

[0198] Two or more different tubes may be connected to the flexible circuit 524 via the system static circuit connector 528 and provide fluid to or receive fluid from the blood component separation bladder 536. The circuit outlet tube 112 exits the system static circuit connector 528 from the flexible circuit 524. The circuit outlet tube 112 may also include another line sensor 812 disposed thereon or therein to detect fluid, air, cell concentration, color, and / or color change in the fluid from the flexible circuit 524; the line sensor 812 may be the same or similar in type and / or function to the sensors 804, 312, 320, 808, and / or 284 described above. A second CPS sensor 816 or fluid sensor may also be disposed in or on the pipeline 112. The sensor 816 may detect, but is not limited to, one or more of the following: the presence or absence of fluid, the pressure within the conduit 112, and / or other characteristics of the fluid in the conduit 112. Sensor 816 may be the same or similar in type and / or function to sensors 804, 312, 320, 808, 812, and / or 284 described above.

[0199] Tube 112 may flow into a plasma air detection sensor 284 before saline and plasma tube y-connector 280 separates circuit outlet tube 112 into saline tube 116 and plasma tube 120. Return pump 212 may interact with circuit outlet tube 112 and may cause fluid or air to flow through tube 112 from flexible circuit 524 or from saline bag 118 and / or plasma collection bottle 122.

[0200] The saline bag 118 and associated tubing, as previously described, can provide saline back to the donor 102 through the system 200. The saline flow control valve 288 can isolate the saline bag 118 from the rest of the system 200. Additionally, the plasma collection bottle 122 can receive plasma from the flexible circuit 524 when processing or separating whole blood. The plasma collection bottle 122 can be selectively isolated from the system via the plasma flow control valve 286.

[0201] Fig. 9An example electrical and control system 900 is shown that controls the functionality of the apheresis system 200. The control system 900 may include one or more nodes that may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of the apheresis system 200.

[0202] Each node can be used to control a different part of the single collection system 200. For example, the control system 900 may include a box node 904 and a centrifuge node 908, which can respectively control or communicate with components of the blood component collection device 500 (and connected hardware or mechanical components that interact with the soft box assembly 300) and the centrifuge assembly 400 (and connected hardware or mechanical components connected thereto). The box node 904 and the centrifuge node 908 can communicate wirelessly or through some other electrical or data connection. In at least one exemplary embodiment, the independent nodes 904, 908 can be two parts of a single node 902. In this way, each node 904, 908 can have the same physical hardware for operation to control different functions. An example of a box node 904 can be as combined with Fig.10 As described; the centrifuge node 908 can be such as combined Fig.11 as described.

[0203] Each of the nodes 904, 908 may communicate with one or more sensors 916, 920, and / or 924. Fig. 9 924. In some embodiments, the present invention provides a plurality of sensors 916 to 924, and a plurality of sensors 916 to 924 are connected to each other. The plurality of sensors 916 to 924 are connected to each other by a plurality of sensors 916 to 924 ...

[0204] Nodes 904, 908 may also communicate with one or more pump drivers, pump motors 936, 940, 944 (referred to as "pumps"). Fig. 9948. Nodes 904, 908 can communicate with pumps 936 to 944 via direct wired or wireless communications or via bus 932. Bus 932 can be a control area network (CAN) bus, USB, or other type of bus architecture to communicate with pumps 936 to 944. Pumps 936 to 944 can include pumps 216, 208, and / or 212, as previously described. The functionality of pumps 936 to 944 can be as described herein.

[0205] Fig.10 An exemplary cartridge node 904 is shown. The cartridge node 904 may include one or more of the following: a controller 1004, a memory 1008, a valve controller 1020, and / or a communication interface for a CAN bus 1016, a UART 1012, or other type of bus. The cartridge node 904 may include other hardware, firmware, and / or software, not shown for clarity.

[0206] The controller 1004 can be any type of microcontroller, microprocessor, field programmable gate array (FPGA), application specific integrated circuit (ASIC), and / or other. An exemplary controller 1004 can be a NK10DN512VOK10 microcontroller manufactured and sold by N9P USA, Incorporated, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are also possible. The controller 1004 can control other types of devices or manage the functions of other types of devices (such as valves 320A, 320B, 320C, 286, 288, pumps 936 to 944). In addition, the controller 1004 can communicate with various sensors 916 to 924 or other devices to receive or send information about the function of the apheresis system 200.

[0207] Other examples of a processor or microcontroller 1004 as described herein may include, but are not limited to, at least one of the following: 800 and 801, with 4G LTE integration and 64-bit computing 610 and 615, with 64-bit architecture A7 processor, M7 motion coprocessor, Series processors, Core TM Processor series, Processor series, Atom TM Processor series, Intel Processor series, i5-4670K and i7-4770K 22nm Haswell, i5-3570K 22nm Ivy Bridge, FX TM Series processors, FX-4300, FX-6300 and FX-8350 32nm Vishera, Kaveri processors, Cortex TM -M processor, Cortex-A and ARM926EJ-S TM processor, other industrial equivalent processor, and may use any known or future developed standard, instruction set, library and / or architecture to perform computing functions.

[0208] The memory 1008 may be any type of memory including random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, any suitable combination of the foregoing, or other type of storage or memory device that stores and provides instructions to program and control the controller 1004. The memory 1008 may provide all types of software or firmware that programs the functions of the controller 1004, as described below.

[0209] The controller 1004 can communicate with one or more valve controllers 1020. As described herein, each valve 320A, 320B, 320C, 286, 288 can be controlled by the valve controller 1020 and can be associated with components of the system 200 as described herein. The valve controller 1020 can provide electrical signals, operating instructions, or power to close or open any of the valves described herein, such as the saline and plasma valve housing 276, the plasma flow control valve 286, the saline flow control valve 288, the first fluid control valve 320A, the first fluid control valve 320A, and / or the aspiration fluid control valve 320C.

[0210] The controller 1004 can be connected to the bus 912, 932 (e.g., a UART bus and / or a CAN bus) or other bus through a transceiver 1012, 1016 disposed external to the controller 1004 or integrated into the controller 1004. The UART transceiver 1012 can communicate with one or more of the sensors 916 to 924 or other devices. Similarly, the CAN bus transceiver 1016 can communicate with one or more of the pump controllers 936 to 944 or other devices. The UART transceiver 1012 and bus and the CAN bus transceiver 1016 and bus are well known in the art and do not require further explanation herein.

[0211] Fig.11An exemplary centrifuge node 908 is shown. Centrifuge node 908 may include the same or similar types of components as box node 904. For example, centrifuge node 908 may include controller 1104 and / or UART transceiver 1112. Similar to controller 1004, controller 1104 may be any type of processor or microcontroller, for example, including the NK10DN512VOK10 microcontroller unit with 32-bit architecture from N9PUSA Incorporated, as previously described, or other controllers, processors, for example, as previously described devices.

[0212] The controller 1104 can communicate directly with the sensors 916 to 924 through the UART transceiver 1112 or through other buses or systems. The controller 1104 can 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 motor controller, which is used to start or rotate the centrifuge 400 or control the speed setting or other functions of the centrifuge 400.

[0213] In at least one exemplary embodiment, the controller 1104 can 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. In addition, the controller 1104 can communicate with and / or control a strobe light 1112, which is any light that flashes periodically in synchronization with the rotation speed of the motor so that the operation of the filler 460 can be seen by an operator of the apheresis system 200, as previously described. Thus, the controller 1104 can communicate with the strobe light 1112 to change the flashing frequency of the strobe light 1112 and / or the intensity of the strobe light 1112.

[0214] Fig.12 An exemplary method 1200 for performing apheresis of blood components (e.g., plasma) using system 200 according to at least one exemplary embodiment of the present disclosure is shown. FIG. 17A to FIG. 17T The method 1200 is described. Therefore, the method 1200 will be described in conjunction with or with reference to those drawings. Fig.12 12 shows a general order of steps of method 1200. Generally, method 1200 begins with start operation 1204 and ends with operation 1220. Method 1200 may include more or fewer steps, or may differ from Fig.12The order of the steps is arranged in the manner shown in . The method 1200 can be performed at least in part as a computer-executable instruction set, which is executed by a computer system, a processor, a box microcontroller 1004, a centrifuge microcontroller 1104 and / or other devices and is encoded or stored on a computer-readable medium. In at least one exemplary embodiment, the method 1200 can be performed at least in part by a series of components, circuits, and / or gates created in a hardware device, such as a system on a chip (SOC), an application-specific integrated circuit (ASIC) and / or a field-programmable gate array (FPGA). Hereinafter, the method 1200 will be referred to, for example, in conjunction with Figures 1 to 11 The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processing, models, environments and / or apheresis systems are explained.

[0215] The method 1200 can be generally divided into three phases, wherein each phase includes a series of steps or processes. Fig.12 and reference to the description of the steps or processes Figures 13 to 16 The method 1200 may include a prepare system stage at step 1208. In this stage 1208, the operator may prepare the system 200 for apheresis, which may include the steps of placing a needle in the donor 102, performing other operations to prepare for blood extraction, and inserting the blood component collection device 500 into the system. Examples of steps that may be included in the prepare system stage 1208 may be as described in conjunction with Fig.13 as described.

[0216] At step 1212, method 1200 may enter a plasma draw phase. The plasma draw phase 1212 may be performed as described in conjunction with Fig.14 The aspirate plasma phase 1212 may include aspirating blood, centrifuging the blood to extract plasma (and / or other blood components), and pushing high hematocrit blood (e.g., red blood cells) and / or other blood components back to the donor 102 in various return cycles (until a complete sample of plasma and / or other blood components is collected). The start of the return cycle may be triggered based on the presence of one or more blood components (e.g., platelets and / or red blood cells) at a predetermined location in the apheresis system.

[0217] The final stage of method 1200 may be the unloading of disposables stage at step 1216. Unloading of disposables stage 1216 may be combined with Fig.15 The unload disposables phase 1216 may include completing the apheresis process, removing the needle from the donor 102, unloading the blood component collection device 500, and completing the process. Each of the three phases 1208 to 1216 and the steps or processes associated therewith will now be described below.

[0218] Fig.13 An exemplary method of preparing the apheresis system 200, as described in stage 1208, is shown in accordance with at least one exemplary embodiment of the present disclosure. The method 1300 may begin with a start operation 1304 and end with an operation 1328. The method 1300 may include more or fewer steps, or may differ from Fig.13 The method 1300 may be performed at least in part as a computer executable instruction set executed by a computer system, a processor, a cartridge microcontroller 1004, a centrifuge microcontroller 1104, and / or other device and encoded or stored on a computer readable medium. In at least one exemplary embodiment, the method 1300 may be performed at least in part by a series of components, circuits, and / or gates created in a hardware device such as a SOC, an ASIC, and / or an FPGA. Hereinafter, the method 1300 will be referred to as described in conjunction with Figures 1 to 12 The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processing, models, environments, apheresis systems and / or methods are explained.

[0219] In step 1308, the user or operator may load the blood component collection device 500. In this step 1308, the user may load the blood component collection device 500 into the system 200, including inserting the flexible circuit 524 into the circuit receiving bracket 426 and inserting the blood component separation capsule 536 into the filler 460 (both of which may be as shown in FIG. Fig.16 In addition, the soft box 340 can be installed in the soft box assembly 300, such as in combination with Figure 1 , Figure 2A , Figure 2B , Figure 3A and / or Figure 3B The circuit inlet tube 108B can be inserted into the guide tube guide 244 and / or the end tube guide 252 to the aspiration pump 208 to cause fluid movement in the circuit inlet tube 108B and other components of the blood component collection device 500. Similarly, the anticoagulant tube 110 can be placed in a tubing guide similar to the guides 244, 252 to allow the AC pump 216 to move anticoagulant into the anticoagulant tube 110 or other parts of the blood component collection device 500. The circuit outlet tube 112 can be inserted into similar guides 244, 252 to allow the return pump 212 to move blood components (e.g., plasma) into the plasma collection bottle 122 or to move saline from the saline bag 118 to the circuit outlet tube 112 or other parts of the blood component collection device 500.

[0220] like Figure 2DAs shown, the saline and plasma tubing y-connector 280 can be mounted to the plasma and saline valve control system 228 to allow valves 286, 288 to control fluid flow from and / or to the plasma collection bottle 122 and / or saline bag 118. The AC bag 114 can be mounted to the anticoagulant support 232A, the plasma collection bottle 122 can be placed in the plasma collection bracket 232C, and the saline bag 118 can be mounted to the saline support 232B, as shown. Figures 1 to 2B With the blood component collection device 500 installed in the single collection system 200, the single collection system 200 can be as follows Fig.17A and 17B During this step, the states of the various components of the apheresis system 200 may be as follows:

[0221]

[0222] Table 1: Loading Kit Status

[0223] As shown in the above table and subsequent tables, the aspiration pump 208 and the return pump 212 can close the loop inlet tube 108B and the anticoagulant tube 110, respectively. In this way, the aspiration 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 moves in a counterclockwise rotation. The abbreviation "AF" stands for "Auto Flow" and indicates that the pump operates at the flow rate of blood from the blood donor 102. The AF flow rate prevents the aspiration system 200 from aspirating blood from the blood donor 102 or allowing blood to flow back into the blood donor 102, and / or the AF optimizes the flow rates of aspiration and return while improving the safety of the blood donor.

[0224] In step 1312, the saline bag 118 may be pierced. The user may remove any safety covering from the bag spike fitting 512 at the distal end of the saline tube 116 to pierce the saline bag 118 containing saline. In at least one exemplary embodiment, the saline tube 116 may be mechanically attached to the saline bag 118 (e.g., via a Luer connector), and the user may adjust a frangible device or other removable barrier to allow saline to flow out of the saline bag 118. Thus, piercing the saline bag 118 allows saline to flow into the blood component collection device 500, to or through the saline flow control valve 288. During this step, the states of the various components of the apheresis system 200 may be as follows:

[0225]

[0226] Table 2: Salt water injection status

[0227] In step 1316, priming with saline 1712 is performed. Priming with saline 1712 includes the cartridge microcontroller 1004 directing the opening of the saline flow control valve 288, such as Fig.17DAs shown. The box microcontroller 1004 can receive instructions for the user interface or program to start the apheresis process, which begins by priming the saline 1712. As a result, saline 1712 moves from the saline bag 118 to the plasma air detection sensor 284 through the saline flow control valve 288. The box microcontroller 1004 directs the counterclockwise rotation of the return pump 212 so that the volume flow of saline 1712 is from the saline bag 118 and through the saline tube 116 and the saline and plasma tubing y-connector 280 (installed in the plasma and 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 lack of air in the circuit outlet tube 112, a signal is sent to the box microcontroller 1004. The box microcontroller 1004 can instruct the return pump 212 to stop rotating and instruct the saline flow control valve 288 to close, which prevents saline 1712 from further entering the circuit outlet tube 112 substantially beyond the plasma air detection sensor 284. At this point in the process, the apheresis system can be as shown. Fig.17E During this step, the states of the various components of the apheresis system 200 may be as follows:

[0228]

[0229] Table 3: Pre-filled brine status

[0230] It should be noted that the reflux pump 212 is described as rotating counterclockwise. This direction of rotation is associated with the position of the reflux pump 212 relative to the circuit outlet tube 112. If the reflux pump 212 is installed so that the circuit outlet tube 11 is located below the reflux pump 212, the reflux pump 212 will rotate in a clockwise direction to remove saline 1712 from the saline bag 118. Therefore, throughout the specification, the pump rotation direction will be described for the reflux pump 212, the suction pump 208 and / or the AC pump 216, but if the pumps 208, 212, 216 are installed or placed differently, these rotation directions may be different. In addition, other types of pumps may be used, which will change how the pumps operate to move various liquids or air 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 methods and steps.

[0231] Additionally, the moving volumes and moving rates in the apheresis system 200 are mentioned or described in the tables included herein. However, these volumes and rates depend on the size of the tube, the size of the bag used, the desired volume of the blood component collected (e.g., approximately 880 mL of plasma), and other considerations. State or national laws and other directives may govern the volumes and rates used in the apheresis system 200, or those moving volumes and moving rates may be predetermined based on the guidance of a medical professional or based on the characteristics of the donor 102. Therefore, the moving volumes and moving rates are merely exemplary, but one skilled in the art will know which volumes and moving rates to establish for the following steps and processes.

[0232] As follows, in step 1320, anticoagulant (AC) 1702 may be inserted. Inserting anticoagulant 1702 may be a process similar to inserting saline 1712. For example, tube fitting 508 may be attached to AC bag 114 by a user. The user may break a breakable, open a valve or other device, or adjust some structure that allows AC 1702 to flow into anticoagulant tube 110. In at least one exemplary embodiment, the user may insert a needle into AC bag 114. At this point in the process, apheresis system 200 may be as follows. Fig.17E The user may signal the box microcontroller 1004 through a user interface or other user input device that the AC bag 114 has been connected or pierced. During this step, the status of the various components of the apheresis system 200 may be as follows:

[0233]

[0234]

[0235] Table 4: Anticoagulant status

[0236] In step 1324, in response to a signal from the user, the cartridge microcontroller 1004 may activate the AC 1702. To activate the AC 1702, the cartridge microcontroller 1004 may instruct 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 tube 110, as shown. Fig.17F and Figure 17GAs shown. The donor supply tube 104 may be closed by a clamp, a frangible device, or other structure. Thus, AC 1702 does not flow from the donor supply tube 104 to the donor 102. Instead, the AC pump 216 may push the anticoagulant 1702 into the box inlet tube 108A, into the soft box 340, and partially into the loop inlet tube 108B. In at least one exemplary embodiment, AC 1702 flows through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316 but does not necessarily enter the first tube segment 368A or the second tube segment 368B. Thus, the box microcontroller 1004 may close the first fluid control valve 320A to prevent AC 1702 from flowing into the first tube segment 368A, the drip chamber 354, or the second tube segment 368B. Presetting AC 1702 to the first bypass branch 358A, the second bypass branch 358B and / or the fluid sensor 316 ensures proper flow of whole blood during the first withdrawal of whole blood from the donor 102 and prevents large amounts of AC 1702 from returning to the donor 102 from the drip chamber 354 when red blood cells return after the process.

[0237] To determine when to stop the AC pump 216, the cartridge microcontroller 1004 may 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 the cartridge microcontroller 1004 with an indication that the AC 1702 has reached the sensor 316, the cartridge microcontroller 1004 may continue to direct the AC pump 216 for a predetermined period of time until a known volume of AC 1702 is pumped through the second cartridge port 360B and partially into the circuit inlet tube 108B. Thus, the priming of the AC 1702 places the apheresis system 200 in a state such as Figure 17G During this step, the states of the various components of the apheresis system 200 may be as follows:

[0238]

[0239] Table 5: Priming Anticoagulant Status

[0240] In at least one exemplary embodiment, Figure 17GAs shown, the direction of the AC pump 216 can be reversed. At least a portion of the anticoagulant 1702 can be pumped back into the AC bag 114 and / or the cartridge inlet tube 108A and / or a portion of the anticoagulant tube 110. In at least one exemplary embodiment, the cartridge microcontroller 1004 can instruct the aspiration fluid control valve 320C to close to maintain 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 AC 1702 stops passing through the sensor 312 and send a signal to the cartridge microcontroller 1004. Likewise, the cartridge microcontroller 1004 can continue to direct the AC pump 216 for a predetermined period of time until a known volume of AC 1702 is pumped back through the cartridge inlet tube 108A. Thus, AC 1702 is pumped back into the cartridge inlet tube 108A. Figure 17G The state shown leaves the apheresis system 200. After the anticoagulant 1702 passes through the donor air detection sensor 312, the amount of anticoagulant remaining in the cartridge inlet tube 108A, the tube connector 106, and / or the anticoagulant tube 110 can be determined by the cartridge microcontroller 1004. This process leaves some anticoagulant in the cartridge inlet tube 108A, but reduces the amount of AC to prevent the problem of too much AC mixing with the incoming whole blood. At stage 1212 ( Fig.12 ), the apheresis system 200 is primed and ready to draw whole blood. During this step, the states of the various components of the apheresis system 200 may be as follows:

[0241]

[0242] Table 6: Pre-charge AC completion status

[0243] Fig.14 An exemplary method 1400 showing the aspiration plasma phase 1212 is shown according to an embodiment of the present disclosure. The method 1400 may begin with a start operation 1404 and end with an operation 1440. The method 1400 may include more or fewer steps, or may differ from Fig.14 The method 1400 may be performed at least in part as a set of computer executable instructions executed by a computer system, a processor, a cartridge microcontroller 1004, a centrifuge microcontroller 1104, and / or other devices and encoded or stored on a computer readable medium. In at least one exemplary embodiment, the method 1400 may be performed at least in part by a series of components, circuits, and / or gates created in a hardware device such as a SOC, an ASIC, and / or an FPGA. Hereinafter, the method 1400 will be referred to as described in conjunction with Figures 1 to 13 The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processing, models, environments, apheresis systems and / or methods are explained.

[0244] In step 1408, the donor 102 may be penetrated with a needle. The phlebotomist, apheresis technician, or other medical professional may attach a lumen needle to the tube fitting 504 and place the needle into a blood vessel (e.g., a vein) of the donor. Thus, the apheresis system 200 may be fluidly connected to the donor 102 and ready to withdraw whole blood. Thus, the apheresis system 200 begins the plasma withdrawal phase 1212 with the donor 102 ready to provide whole blood, as shown in FIG. Fig.17H During this step, the states of the various components of the apheresis system 200 may be as follows:

[0245]

[0246]

[0247] Table 7: Blood donor status

[0248] In step 1412, the cartridge microcontroller 1004 of the apheresis system 200 may begin to draw whole blood 1706. The cartridge microcontroller 1004 may direct the AC pump 216, the aspiration pump 208, and / or the return pump 212 to operate by rotating clockwise. The AC pump 216 pushes the anticoagulant 1702 toward the plasma collection bottle 122, causing the AC 1702 to mix with the whole blood 1706 drawn from the donor 102 in the tubing connector 106 (and possibly in the donor supply tube 104) and other components distal to the tubing connector 106. The aspiration pump 208 and / or the return pump 212 draw the whole blood 1706 from the donor 102 (and the AC) into the soft cartridge 340, the flexible circuit 524, and / or the blood component separation bladder 536. During this process 1412, the cartridge microcontroller 1004 and the centrifuge microcontroller 1008 may communicate to inform the centrifuge microcontroller 1008 that aspiration has begun. In response to the indication that aspiration has begun, the centrifuge microcontroller 1008 may instruct the rotor and motor assembly 414 of the centrifuge assembly 400 to begin spinning or starting. The initial rate of spinning may be slow to allow the blood component separation capsule 536 to be positioned in the filler insertion cavity 492 and whole blood 1706 to be aspirated into the blood component separation capsule 536. During this step 1412, the state of the apheresis system 200 may be as follows: Fig.17I During this step, the states of the various components of the apheresis system 200 may be as follows:

[0249]

[0250] Table 8: Start extraction status

[0251] In step 1416, the blood component separation capsule 536 is pre-filled with whole blood 1706 in an area adjacent to the channel inlet 468, the channel end 472 and / or the channel path protrusion 476. The box microcontroller 1004 stops the operation of the return pump 212, but continues to operate the AC pump 216 and the suction pump 208. The whole blood 1706 is pushed through the first tube segment 368A, the drip chamber 354 and / or the second tube segment 368B. The whole blood 1706 is pushed from the soft box 340 through the flexible loop 524 and into the blood component separation capsule 536, reaching the capsule 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 donor 102. During step 1416, the apheresis system 200 can be as follows Fig.17J During this step, the states of the various components of the apheresis system 200 may be as follows:

[0252]

[0253]

[0254] Table 9: Precharge channel status

[0255] Further communications occur between the cartridge microcontroller 1004 and the centrifuge microcontroller 1008 to indicate priming of the channel. In response to these communications, the centrifuge microcontroller 1008 directs the rotor and motor assembly 414 of the centrifuge assembly 400 to begin spinning or rotating at a higher number of revolutions per minute (RPM).

[0256] Referring now to step 1420, the cartridge microcontroller 1004 begins to perform a first aspiration of plasma 1704 or other blood components from the whole blood 1706. The cartridge microcontroller 1004 continues to operate the AC pump 216 to provide anticoagulant 1702 into the cartridge inlet tube 108A to mix with the whole blood 1706 from the donor 102. In addition, the cartridge microcontroller 1004 continues to operate the aspiration pump 208 to move the whole blood 1706 into the blood component separation capsule 536 to separate the plasma 1704 from the whole blood 1706. In order to produce the separation of the plasma 1704, the cartridge microcontroller 1004 notifies the centrifuge microcontroller 1008 that the aspiration step has begun. In response to these communications, the centrifuge microcontroller 1008 directs the rotor and motor assembly 414 of the centrifuge assembly 400 to begin rotating or turning at an even higher revolutions per minute (RPM) (e.g., substantially 5000 RPM) to begin separating the red blood cells 1708 from the plasma 1704, as shown in FIG. Figure 17K The aspiration pump 208 continues to push the plasma 1704 through the flexible circuit 524, the system static circuit connector 528 and into the circuit outlet tube 112. The aspiration process 1420 continues until Figure 17LAt some point shown, the platelets 1710 separated from the whole blood 1706 reach the line sensor 812, which signals the cartridge microcontroller 1004 that the total amount of plasma 1704 from the whole blood 1706 pushed into the blood component separation capsule 536 has been aspirated, and the cartridge microcontroller 1004 proceeds to step 1424. During this step, the states of the various components of the apheresis system 200 may be as follows:

[0257]

[0258] Table 10: Extraction status

[0259] Additionally or alternatively, during separation of plasma 1704, as the RBC interface 1709 rises within the centrifugal field, the interface 1709 between plasma 1704 and red blood cells (RBC) 1708 and / or the radial position of the RBC interface 1709 within the blood component separation capsule 536 can be determined. The radial position of the interface 1709 can be determined by monitoring the inlet pressure of the centrifuge assembly 400. For example, a sensor 808 disposed on or in the tube 108B can determine the inlet pressure of the centrifuge assembly 400. Alternatively, another sensor disposed on or in the flow path entering the centrifuge assembly 400 can determine the inlet pressure. As the RBC interface 1709 rises within the blood component separation capsule 536, the plasma 1704 is displaced by the red blood cells 1708 in the RBC bed. For each incremental increase in the radial position of the RBC interface 1709 (Dlta R), the back pressure affecting the inlet pressure of the centrifuge assembly 400 (e.g., the back pressure on the sensor 808 or another sensor) can be increased by a multiple of Dlta R and the average value (G) of the centrifugal field between the radial position of the channel inlet and the radial position of the RBC interface 1709, and the RBC bed density is less than the plasma density. More simply, the back pressure affecting the inlet pressure of the centrifuge assembly can be increased by: Dlta R×(RBC bed density-plasma density)×G. For example, in at least one exemplary embodiment, when the centrifuge is rotated at about 5000 RPM and RBC bed formation is initiated at a radius of about 67 mm, the total back pressure change from the start of RBC bed formation to the exit of the RBC at the center of rotation can be about 220 mmHg.

[0260] In step 1426, the cartridge microcontroller 1004 determines whether the donation is complete when the platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach the line sensor 812, as determined by the sensor 812 observing a change in the color or other characteristic of the fluid. A complete donation means that the entire amount of plasma 1704 required or desired has been withdrawn and placed in the plasma collection bottle 122. In at least one exemplary embodiment, the cartridge microcontroller 1004 can determine by weight or volume whether the complete donation volume (e.g., approximately 880 mL) has been withdrawn. This situation can be as follows Figure 17L 14, wherein plasma 1704 has been extracted and is still present in the circuit outlet tube 112 and is provided to the plasma collection bottle 122 via the plasma tube 120. If it is an incomplete donation, meaning that the plasma collection bottle 122 has not yet reached its desired weight or volume limit, the process 1400 may proceed to a "no" to return to step 1428. If it is a complete donation, the method 1400 may proceed to a "yes" to finally return to step 1432.

[0261] Alternatively, when it is determined that the RBC interface 1709 is in the radially innermost position, the cartridge microcontroller 1004 determines in step 1426 whether the donation is complete. For example, the radially innermost position may be at a location adjacent to the filler loop connector 532. A complete donation means that the entire amount of plasma 1704 required or desired has been aspirated and placed in the plasma collection bottle 122. In at least one exemplary embodiment, the cartridge microcontroller 1004 may determine by weight or volume whether the entire donated blood volume (e.g., approximately 880 mL) has been extracted. This may be as follows Figure 17L 14, wherein plasma 1704 has been extracted and is still present in the circuit outlet tube 112 and is provided to the plasma collection bottle 122 via the plasma tube 120. If it is an incomplete donation, meaning that the plasma collection bottle 122 has not yet reached its desired weight or volume limit, the process 1400 may proceed to a "no" to return to step 1428. If it is a complete donation, the method 1400 may proceed to a "yes" to finally return to step 1432.

[0262] By performing the return step 1428 upon determining that the RBC interface 1709 is at the radially innermost position, rather than upon platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reaching the line sensor 812, the time to complete the extraction process 1420 is reduced, thereby reducing the overall time to complete the method 1400.

[0263] In returning to step 1428, if Figure 17LAs shown, the cartridge microcontroller 1004 instructs the aspiration pump 208 to stop and reverses the direction of the return pump 212 to operate in a counterclockwise motion to push the plasma 1704 from the plasma collection bottle 122 through the plasma tube 120, into the circuit outlet tube 112, and toward the soft cartridge 340. The cartridge microcontroller 1004 further directs the aspiration fluid control valve 320C to close and open 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 circuit outlet tube 112, the flexible circuit 524, the blood component separation bladder 536, through the drip chamber 354, and to the donor 102. Importantly, as Figure 17L As shown, during this return step 1428, the filler 460 continues to rotate at the extraction speed (e.g., approximately 5000 RPM). The 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 passed the sensor 808 and may have reached the drip chamber 354, as shown. Fig.17M At this point, valve 320B and valve 320A are closed again, and whole blood 1706 can flow through first bypass branch 358A, second bypass branch 358B, and / or fluid sensor 316 again. During this step 1428, the states of various components of the apheresis system 200 can be as follows:

[0264]

[0265] Table 11: Return Status

[0266] Returning to step 1428, we move to the second aspiration step 1420. A new aspiration is performed in a similar manner to step 1420 described above. However, a section of high hematocrit blood remains in the drip chamber 354. By passing new whole blood 1706 through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316, less high hematocrit blood is returned to the blood component separation capsule 536, where red blood cells cannot extract more plasma 1704 therefrom. Thus, the bypass provided by the softbox 340 makes it more efficient to remove plasma 1704 from the whole blood 1706 in the second extraction step 1420 and subsequent aspiration steps.

[0267] Returning to step 1428 and continuing the pumping step 1420 will repeat a certain number of cycles. The final pumping step 1420 can be as follows Fig.17N The plasma 1704 in the plasma collection bottle 122 has reached the desired and / or maximum amount, for example, 880 mL. Fig.17NWhen the plasma 1704 reaches the desired and / or maximum amount in the plasma collection bottle 122, a final return is required in step 1432. During this return step, the status of the various components of the apheresis system 200 may be as follows:

[0268]

[0269] Table 12: Final return status

[0270] In step 1432, the total amount of plasma 1704 extracted from the donor 102 is in the plasma collection bottle 122, and the apheresis system 200 can push the remaining plasma 1704, red blood cells 1708, and any other blood components into the donor 102. The cartridge microcontroller 1004 can instruct the plasma flow control valve 286 to close to keep the plasma donation in the plasma collection bottle 122. The return pump 212 can continue to operate in a counterclockwise rotation to push the red blood cells 1708 and any plasma 1704 or other blood components back to the donor 102.

[0271] After or as part of the final return 1432, the saline 1712 may be returned to the donor 102 in step 1436, as described in Fig.17O As shown. In this step 1436, the box microcontroller 1004 opens the 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 operate counterclockwise. The centrifuge microcontroller 1008 stops the filler 460 from rotating. The saline 1712 from the saline bag 118 is pushed through the blood component separation bag 536, the drip chamber 354 and various tubes back to the blood donor 102. The various blood components remaining in the blood component collection device 500 are pushed back into the blood donor 102 along with a certain amount of saline 1712. The saline 1712 helps replenish the fluid of the blood donor 102 and is required in some jurisdictions. The saline 1712 continues to return until a predetermined amount of saline 1712 is provided to the user, which predetermined amount is determined by the weight or volume of the saline 1712 that has left the saline bag 118. As Fig.17O As shown, the plasma donation is completed. During this step, the status of the various components of the single collection system 200 can be as follows:

[0272]

[0273]

[0274] Table 13: Saltwater return status

[0275] Fig.15An exemplary method for unloading the plasma and blood component collection device 500 from the apheresis system 200, as described in the unloading stage 1216, is shown in accordance with at least one exemplary embodiment of the present disclosure. The method 1500 may begin with a start operation 1504 and end with an operation 1528. The method 1500 may include more or fewer steps, or may differ from Fig.15 The method 1500 may be performed at least in part as a set of computer executable instructions executed by a computer system, a processor, a cartridge microcontroller 1004, a centrifuge microcontroller 1104, and / or other devices and encoded or stored on a computer readable medium. In at least one exemplary embodiment, the method 1500 may be performed at least in part by a series of components, circuits, and / or gates created in a hardware device such as a SOC, an ASIC, and / or an FPGA. Hereinafter, the method 1500 will be referred to as described in conjunction with Figures 1 to 14 The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processing, models, environments, apheresis systems and / or methods are explained.

[0276] In step 1508, the channel is drained. In at least one exemplary embodiment, the cartridge microcontroller 1004 operates the extraction pump 208 in a counterclockwise direction to continue to drive the saline 1712 substantially completely out of the blood component separation bladder 536 and the remainder of the blood component collection device 500, as shown. Figure 17P At some point, substantially the entire amount of blood components and / or saline 1712 is pushed back into the donor 102, in which case all pumps 216, 208, and 212 cease operation. The fluid control valve 320A, the first fluid control valve 320A, the saline flow control valve 288, and any other valves may be closed by the cartridge microcontroller 1004. Once the various valves are closed, only a trace amount of saline 1712 or no saline at all may remain in the blood component collection device 500. The state of the apheresis system 200 may be as follows: Figure 17Q During this step, the states of the various components of the apheresis system 200 may be as follows:

[0277]

[0278] Table 14: Channel Drain Status

[0279] like Figure 17R As shown, the blood component collection device 500 may be sealed in step 1512. Sealing of the blood component collection device 500 may include clamping the donor supply tube 104 leading to the blood donor 102 and fusing and sealing the tube at various locations. The seal may be a fusion of the tube, as the tube may be a thermoplastic, such as Figure 17RFor example, the anticoagulant tube 110, saline tube 116, plasma tube 120 (above the plasma flow control valve 286), and donor supply tube 104 are all heat fused to separate the AC bag 114, plasma collection bottle 122, saline bag 118, and donor 102 from the rest of the blood component collection device 500. During this step, the status of the various components of the apheresis system 200 may be as follows:

[0280]

[0281]

[0282] Table 15: Seal Kit Status

[0283] In step 1516, the needle may be removed from the donor 102, as shown in 17R. During this step, the status of the various components of the apheresis system 200 may be as follows:

[0284]

[0285] Table 16: Status of blood donors who were not pierced

[0286] In step 1520, the blood component collection device 500 may be unloaded from the apheresis system 200, which requires reversing the binding Fig.13 and Fig.16 During this step, the states of the various components of the apheresis system 200 may be as follows:

[0287]

[0288] Table 1: Uninstallation status

[0289] Once unloaded, the used blood component collection device 500 can be disposed of as medical waste. The plasma collection bottle 122 can be sealed on the plasma tube 120, such as Figure 17S As shown. The sealed area can prevent any liquid from leaking out of the plasma collection bottle 122, saline bag 118 or anticoagulant bag 114. Once sealed, the plasma collection bottle 122 can be removed and used in any process requiring plasma. Figure 17T As shown, in step 1524, the remaining items can be discarded as medical waste and the process is complete. At the end of the process, the status of the various components of the apheresis system 200 can be as follows:

[0290]

[0291]

[0292] Table 18: Completion status

[0293] Fig.16 An exemplary method 1600 for inserting a disposable into a filler of apheresis system 200 according to at least one exemplary embodiment of the present disclosure is shown. Method 1600 may begin with a start operation 1604 and end with an operation 1632. Method 1600 may include more or fewer steps, or may differ from Fig.16 The method 1600 may be performed at least in part as a computer executable instruction set executed by a computer system, a processor, a cartridge microcontroller 1004, a centrifuge microcontroller 1104, and / or other device and encoded or stored on a computer readable medium. In at least one exemplary embodiment, the method 1600 may be performed at least in part by a series of components, circuits, and / or gates created in a hardware device such as a SOC, an ASIC, and / or an FPGA. Hereinafter, the method 1600 will be referred to as described in conjunction with Figures 1 to 15 The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processing, models, environments, apheresis systems and / or methods are explained.

[0294] In step 1608, a filler 460 of the apheresis system 200 can be provided. The filler 460 can be a component of the apheresis system 200 and is configured to receive at least a portion of the blood component collection device 500. In at least one exemplary embodiment, the filler 460 is mounted on a split housing pivot axis 406 that pivots to expose the interior of the upper housing 404B including the filler 460. The user can pivot the upper housing 404B to expose the separation insertion channel 466 or, in at least one exemplary embodiment, the filler 460 can be automatically pivoted by a motor or other mechanical device. The pivoting and / or loading can be combined as described above. FIG. 4D to FIG. 4F and / or FIG. 6A to FIG. 6C as described.

[0295] In step 1612, a blood component collection device 500 including a blood component separation capsule 536 may be provided. The blood component collection device 500 may be pre-packaged and removed from the package. The user may expose the blood component separation capsule 536 for insertion into the separation insertion channel 466, including ensuring that the balloon free end 540B is positioned at the channel path protrusion 476 of the separation insertion channel 466 and the filler loop connector 532 is positioned at the loop connection area 454. With the blood component separation capsule 536 properly positioned, in step 1616, the user may form the blood component separation capsule 536 substantially into the shape of the separation insertion channel 466 and the channel path protrusion 476, as shown in FIG. FIG. 5F to FIG. 5HThus, the user can form the blood component separation capsule 536 generally into a circular shape or any other shape that generally matches the shape of the separation insertion channel 466 .

[0296] In step 1620, the user may insert the formed blood component separation capsule 536 into the separation insertion channel 466 of the filler 460, as shown in FIG. Figure 5G and Figure 5H 46, wherein the capsule free end 540B of the blood component separation capsule 536 is inserted into the channel path protrusion 476 of the separation insertion channel 466. The user can insert the blood component separation capsule 536 into the separation insertion channel 466 at a substantially central position within the filler insertion chamber 492. Centrifugal force generally automatically aligns the blood component separation capsule 536 to the correct position within the filler insertion chamber 492. However, if it is not positioned at a position where the centrifugal force can act on the blood component separation capsule 536, the blood component separation capsule 536 can be ejected from the separation insertion channel 466. Once positioned, the blood component separation capsule 536 can be fixed in place.

[0297] In step 1624, the user connects the filler loop connector 532 of the blood component separation capsule 536 to the loop connection area 454 of the separation insertion channel 466. The mechanical connection can be made by the user snapping the filler loop connector 532 into the loop connection area 454. The size and physical characteristics of the filler insert chamber 492 maintain the blood component separation capsule 536 and the filler loop connector in a stable position in the loop connection area 454, thereby allowing the blood component separation capsule 536 to migrate to the center of the filler insert chamber 492 during operation of the centrifuge 400. The portion of the flexible loop 524 that remains outside or outside the filler 460 can be mounted to the loop capture arm 416. This mounting of the flexible loop 524 allows for the 1ω / 2ω action of the centrifuge 400.

[0298] After the flexible loop 524 is installed, the upper housing 404B is flipped into position in step 1628. Thus, the filler 460 can be pivoted through the hinge axis 406 (e.g., hinge) into the interior of the system housing 204. The centrifuge housing 404 rotates with the blood component collection circuit 520 through the loop in the centrifuge split housing 404 into the gap 436. When the blood component collection circuit 520 is loaded in the loop loading position 520A, a portion of the blood component collection circuit 520 can be partially received, held and / or supported by the loop receiving bracket 426, such as in combination with the blood component collection circuit 520. FIG. 4A to FIG. 4C The access panel 224 can be pivoted to a closed position that allows operation of the system 200 .

[0299] Exemplary systems and methods of the present disclosure have been described in conjunction with apheresis methods and systems. However, in order to avoid unnecessarily obscuring the present disclosure, the foregoing description omits many known structures and devices. This omission should not be interpreted as a limitation on the scope of the disclosure claimed. Specific details are set forth to provide an understanding of the present disclosure. However, it should be understood that the present disclosure can be implemented in a variety of ways in addition to the specific details set forth herein.

[0300] In addition, although the exemplary aspects, embodiments and / or configurations shown herein show that various components of the system are co-located, certain components of the system may be located remotely, in a remote portion of a distributed network (such as a LAN and / or the Internet), or in a dedicated system. Therefore, it should be understood that the components of the system can be combined into one or more devices, such as box node 904 and centrifuge node 908, or co-located on specific nodes of a distributed network, such as an analog and / or digital telecommunications network, a packet switching network, or a circuit switching network. It will be understood from the foregoing description that for reasons of computational efficiency, the components of the system can be arranged at any position within the distributed network of components without affecting the operation of the system. For example, various components can be located in switches such as PBXs and media servers, gateways, one or more communication devices, at the premises of one or more users, or some combination thereof. Similarly, one or more functional parts of the system can be distributed between telecommunications equipment and associated computing devices.

[0301] In addition, it should be understood that the various links connecting the elements can be wired or wireless links, or any combination thereof, or any other known or later developed element capable of providing and / or communicating data to and from the connected elements. These wired or wireless links can also be secure links and capable of transmitting encrypted information. For example, the transmission medium used as a link can be any suitable carrier for electrical signals, including coaxial cable, copper wire, and optical fiber, and can take the form of sound waves or light waves, such as those generated during radio wave and infrared data communications.

[0302] Furthermore, while the flow charts have been discussed and illustrated with respect to a particular order of events, it should be understood that changes, additions, and omissions may be made to this order without materially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0303] Many variations and modifications of the disclosure may be used.Some features of the disclosure may be provided without providing other features.

[0304] In yet another embodiment, the systems and methods of the present disclosure may be implemented in conjunction with a special purpose computer, a programmed microprocessor or microcontroller and peripheral integrated circuit components, an ASIC or other integrated circuit, a digital signal processor, a hard-wired electronic or logic circuit such as a discrete component circuit, a programmable logic device or gate array such as a PLD, PLA, FPGA, PAL, a special purpose computer, any similar device, etc. In general, any device or apparatus capable of implementing the methods shown herein may be used to implement various aspects of the present disclosure. Exemplary hardware that may be used for the disclosed embodiments, configurations, and aspects include computers, handheld devices, phones (e.g., cellular, Internet enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., single or multiple microprocessors), memory, non-volatile memory, input devices, and output devices. In addition, alternative software implementations including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing may also be constructed to implement the methods described herein.

[0305] In yet another embodiment, the disclosed method can be easily implemented in software using an object or object-oriented software development environment that provides portable source code that can be used on a variety of computer or workstation platforms. Alternatively, the disclosed system can be implemented partially or completely in hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement a system according to the present disclosure depends on the speed and / or efficiency requirements of the system, the specific functions, and the specific software or hardware system or microprocessor or microcomputer system used.

[0306] In yet another embodiment, the disclosed method may be implemented partially in software, which may be stored on a storage medium and executed on a programmed general-purpose computer in cooperation with a controller and memory, a special-purpose computer, a microprocessor, etc. In these cases, the systems and methods of the present disclosure may be implemented as a program (such as an applet, or CGI scripts), as resources resident on a server or computer workstation, as routines embedded in a dedicated measurement system, system components, etc. The system and / or method may also be implemented by physically incorporating it into a software and / or hardware system.

[0307] Although the present disclosure describes the 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 such standards and protocols. Other similar standards and protocols 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 with substantially the same functions. Such alternative standards and protocols with the same functions are considered to be equivalents included in the present disclosure.

[0308] 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 aspects, embodiments, configuration embodiments, subcombinations, and subsets thereof. After understanding the present disclosure, those skilled in the art will understand how to make and use the disclosed aspects, embodiments, and / or configurations. In various aspects, embodiments, and / or configurations, the present disclosure includes providing devices and processes in the absence of items not depicted and / or described herein, or in the absence of items that may have been used in previous devices or processes, for example, to improve performance, achieve ease of use, and / or reduce implementation costs.

[0309] For the purpose of illustration and description, the foregoing discussion has been presented. The foregoing is not intended to limit the present disclosure to one or more forms disclosed herein. For example, in the foregoing specific embodiments, in order to simplify the purpose of the present disclosure, in one or more aspects, embodiments and / or configurations, different features of the present disclosure can be combined together. The features of the aspects, embodiments and / or configurations of the present disclosure can be combined in alternative aspects, embodiments and / or configurations other than those discussed above. The method of the present disclosure should not be interpreted as reflecting the intention that the claims require more features in order to be clearly described in each claim. On the contrary, as reflected in the subsequent claims, the inventive aspects show less than all the features of the single aforementioned disclosed aspects, embodiments and / or configurations. Therefore, the subsequent claims are thus incorporated into the specific embodiments, and each claim is independently a separate preferred embodiment of the present disclosure.

[0310] In addition, although the description includes descriptions of one or more aspects, embodiments and / or configurations and certain variations and modifications, other variations, combinations and modifications are also within the scope of the present disclosure (e.g., possible within the skill and knowledge of those skilled in the art after understanding the present disclosure). The present disclosure is intended to obtain rights that include alternative aspects, embodiments and / or configurations to the extent permitted, including structures, functions, ranges or steps that are alternative, interchangeable and / or equivalent to those claimed, regardless of whether such alternative, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and is not intended to disclose any patentable subject matter.

Claims

1. A method for collecting blood components, the method comprising: Draw whole blood into a centrifuge; rotating the centrifuge to cause centrifugal force to act on the whole blood, thereby separating the whole blood into at least a first blood component and a second blood component different from the first blood component; extracting the first blood component from the centrifuge; detecting when the second blood component is extracted from the centrifuge; as well as After the second blood component is detected and while the centrifuge continues to rotate, the separated first blood component is flowed back toward the centrifuge to remove at least the second blood component from the centrifuge.

2. The method according to claim 1, wherein: The first blood component includes plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof.

3. The method according to claim 2, wherein: The second blood component includes plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof.

4. The method according to claim 2, wherein: The second blood component includes red blood cells.

5. The method according to claim 1, wherein: The centrifuge is rotated at a first speed when separating the first blood component from the whole blood.

6. The method according to claim 5, wherein: The centrifuge continues to rotate at the first speed while the separated first blood component is returned toward the centrifuge.

7. The method according to claim 6, wherein: When the whole blood is drawn into the centrifuge, the centrifuge is rotated at a second speed.

8. The method according to claim 7, wherein: The second speed is slower than the first speed.

9. The method according to claim 1, wherein: The centrifuge is configured to receive a blood component collection device, and the blood component collection device is configured to receive the first blood component.

10. The method according to claim 9, wherein: The method also includes inserting the blood component collection device into the centrifuge.

11. The method according to claim 9, wherein: The blood component collection device includes a blood component separation capsule for separating the first blood component.

12. The method according to claim 11, wherein: The centrifuge includes a filler, and the filler is configured to spin the blood component separation capsule.

13. The method according to claim 12, wherein: The filler includes a separation insert channel configured to receive the blood component separation capsule.

14. The method of claim 13, further comprising inserting the blood component separation capsule into a separation insertion channel of the filler.

15. The method according to claim 1, wherein: Detecting when the second blood component is extracted from the centrifuge includes detecting an interface between the first blood component and the second blood component.

16. The method according to claim 15, wherein: The method also includes detecting a radial position of an interface between the first blood component and the second blood component in the centrifuge.

17. The method according to claim 1, wherein: The method also includes monitoring an inlet pressure of whole blood entering the centrifuge.

18. The method according to claim 17, wherein: Monitoring the inlet pressure includes receiving an output signal from a sensor disposed at an inlet of the centrifuge.

19. The method according to claim 18, wherein: The method also includes determining a back pressure at an inlet of the centrifuge.

20. The method according to claim 19, wherein: The method also includes equating a change in back pressure to a radial position of an interface between the first blood component and the second blood component in the centrifuge.

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