Method and System for High-Throughput Blood Component Collection

Abstract

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

Description

Technical Field

[0005]

[0001] (Cross - reference to related applications) This application claims the priority of 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 applications is incorporated herein by reference.

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

Background Art

[0003] There are two general methods for blood donation / collection. The first method is whole - blood donation from a donor, followed by a centrifugation process to separate blood components from the whole blood based on the density of the blood components. The desired components can be moved manually, semi - automatically, or automatically to a collection container while the whole blood is under the influence of the forces generated by a centrifuge, or in some cases, afterwards. The other method is apheresis collection, which requires a special device.

[0004] In the apheresis method, whole blood is extracted from a donor while the donor is connected to a dedicated device. The whole blood is centrifuged to collect only the desired blood component (e.g., plasma), and all other unwanted blood components can be returned to the donor during the same donation. The donor remains connected to the apheresis device during the separation and collection of the blood components. However, the apheresis process has the disadvantage of being time - consuming and uncomfortable. In many cases, the donor has to remain connected to the device for up to one hour for a blood - component donation. Therefore, making the donation procedure more efficient is currently desired at the sites where apheresis collections are performed.

Summary of the Invention

Problems to be Solved by the Invention

[0005] There is a need for a plasma or other blood component system that can shorten the blood donation time and enhance donor comfort. Embodiments provided herein can improve the efficiency of the blood collection process by using separated blood components to push or push back unwanted blood components to the donor without stopping and restarting the centrifuge. Thus, embodiments herein make the blood collection process more efficient and faster for the donor. [Means for solving the problem]

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

[0007] The needs already mentioned and other needs are addressed by various aspects, embodiments, and / or configurations. While this disclosure provides for exemplary embodiments, it should be understood that individual aspects of this disclosure can be described separately in the claims.

[0008] In at least one exemplary embodiment, the present disclosure provides an assembly for separating components from a multi-component fluid. The assembly includes a filler having a channel for holding a separation bladder of a disposable item, the channel having two opposing walls. The assembly also includes a loop rotation positioning guide including a plurality of bearings. The loop rotation positioning guide holds the flexible loop of the disposable item when the separation bladder is fitted into the channel.

[0009] In at least one exemplary embodiment, the loop rotation positioning guide may include a stopper plate. In at least one exemplary embodiment, the flexible loop may contact the stopper plate when held within the loop rotation positioning guide. In at least one exemplary embodiment, the assembly may constitute part of an apheresis device. In at least one exemplary embodiment, the assembly may be connected to a rotor that rotates the loop rotation positioning guide around a rotation axis. In at least one exemplary embodiment, the plurality of bearings may include a plurality of pairs of roller bearings.

[0010] In at least one exemplary embodiment, the Disclosure provides a centrifuge assembly comprising: a centrifuge housing having an outer surface and an internal cavity and rotating about an axis of rotation of the centrifuge assembly; a fluid separation body at least partially located within the internal cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about an axis of rotation; and a fluid line loop arm attached to a portion of the centrifuge housing and extending along the length of the outer surface of the centrifuge housing. The fluid line loop arm includes a bearing set positioned at a point along the length of the outer surface. The bearing set is configured to contact the tubular portion of the interconnected fluid line loops, holding the fluid line loops in an engaged position relative to the centrifuge housing, while allowing the fluid line loops to rotate in the engaged position.

[0011] In at least one exemplary embodiment, the bearing set may include a pair of roller bearings. In at least one exemplary embodiment, the bearing set may include multiple pairs of roller bearings. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis apparatus. In at least one exemplary embodiment, the fluid line loop may be attached at a first end of the fluid line loop to a fixed, non-rotating part of the apheresis apparatus via a first positively-located connector, and the fluid line loop may be interconnected at a second end of the fluid line loop to the fluid separator body in the internal cavity via a second positively-located connector. In at least one exemplary embodiment, the second end of the fluid line loop may rotate with the fluid separator body. In at least one exemplary embodiment, the fluid line loop may be physically and fluidly attached at the second positively-located connector to a disposable fluid separator bladder. In at least one exemplary embodiment, the fluid line loop may include a plurality of lumens, and the fluid separation bladder may include a first flexible sheet that is attached to a second flexible sheet to form a fluid path. The first portion of the fluid path may be narrower than the second portion of the fluid path.

[0012] In at least one exemplary embodiment, the Disclosure provides a method for automatically mounting a fluid line loop to a centrifuge assembly. The method includes the steps of: attaching the fluid line loop to a fluid separation body of a centrifuge assembly at a first end; and rotating the fluid separation body relative to the housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separation body rotates the fluid line loop relative to the housing and guides it into a channel of a loop arm attached to a portion of the housing. The channel includes bearings arranged in a bearing set attached to the loop arm. The bearings hold the fluid line loop in a predetermined position relative to the housing as the centrifuge assembly rotates.

[0013] In at least one exemplary embodiment, the bearing may contact a portion of the fluid line loop as the fluid line loop rotates in the channel relative to the housing at a predetermined position. In at least one exemplary embodiment, the centrifuge housing may rotate in a first rotational direction at a first angular velocity about a rotation axis, and the fluid separation body may rotate at a different second angular velocity about the rotation axis due to 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 fluidly attached to a disposable fluid separation bladder that is at least partially located within the fluid separation body. In at least one exemplary embodiment, the method may further include the steps of attaching a second end of the fluid line loop to a point fixed in the rotational direction of the apheresis device, and rotating the centrifuge assembly about a rotation axis relative to a point fixed in the rotational direction of the apheresis device via the rotor motor assembly of the apheresis device.

[0014] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components through apheresis. The method includes drawing whole blood from a donor into a centrifuge; rotating the centrifuge to act centrifugal force 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 that a second blood component has been extracted; and, after the second blood component has been detected, flowing the separated first blood component back into the centrifuge while the centrifuge continues to rotate, and moving at least a third blood component from the centrifuge back to the donor.

[0015] In at least one exemplary embodiment, the first blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the second blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the third blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the first blood component may include two or more of plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the centrifuge may rotate at a first speed when separating the first blood component from the whole blood. In at least one exemplary embodiment, the centrifuge may continue to rotate at the first speed when returning the separated first blood component to the centrifuge. In at least one exemplary embodiment, the centrifuge may rotate at a second speed when drawing whole blood from the donor into the centrifuge. In at least one exemplary embodiment, the second speed may be slower than the first speed. In at least one exemplary embodiment, the first blood component may be separated from the whole blood in a blood component collection set inserted into the centrifuge. In at least one exemplary embodiment, the centrifuge may include a filler for rotating a blood component separation bladder associated with the blood component collection set. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a separation insertion channel formed in the filler.

[0016] In at least one exemplary embodiment, the present disclosure provides an apheresis system. The apheresis system includes a first tube having a lumen and being fluidly associated with a needle, for moving whole blood from a donor through the lumen; a draw pump engaged with the first tube for drawing whole blood from the donor into a centrifuge; a centrifuge that rotates to exert centrifugal force on the whole blood, separating the whole blood into at least a first blood component and a third blood component; a blood component separation bladder inserted into the centrifuge and being fluidly associated with the first tube for separating the first blood component from the whole blood; and a fluidly associated with the blood component separation bladder for separating the first blood component from the blood component separation bladder. The system comprises a second tube for moving a blood component 1, a collection container fluidly associated with the second tube and for extracting a first blood component from the apheresis system, a sensor positioned in close proximity to the second tube for detecting that a second blood component has been extracted from whole blood, and a return pump engaged with the second tube for returning the separated first blood component through the second tube to the blood component separation bladder and moving at least a third blood component from the blood component separation bladder back to the donor while the centrifuge continues to rotate after the second blood component has been detected by the sensor.

[0017] In at least one exemplary embodiment, the first blood component may include plasma, and the second blood component may include platelets, red blood cells, high hematocrit blood, or a combination thereof. In at least one exemplary embodiment, the apheresis system may further include an anticoagulant pump configured to draw an anticoagulant from an anticoagulant bag and to mix the anticoagulant with whole blood in a manifold or junction fluidly associated with the first tube. In at least one exemplary embodiment, the centrifuge may include a filler for rotating the blood component separation bladder. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a separation insertion channel formed in the filler.

[0018] In at least one exemplary embodiment, the present disclosure provides a blood component collection set associated with an apheresis system. The blood component collection set includes: a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and being fluidly associated with the needle and moving whole blood through the lumen, through which a draw-in pump engaged with the first tube draws whole blood from the donor; a blood component separation bladder inserted into a centrifuge and being fluidly associated with the first tube and separating a first blood component and a third blood component from the whole blood; and a second tube fluidly associated with the blood component separation bladder and moving the first blood component from the blood component separation bladder. The system comprises a tube and a collection container which is fluidly associated with a second tube and extracts a first blood component from an apheresis system, wherein a sensor is positioned physically close to the second tube to detect that the second blood component has been extracted from whole blood, and after the second blood component has been detected by the sensor, a return pump engaged with the second tube returns the separated first blood component through the second tube to a blood component separation bladder and moves at least a third blood component from the blood component separation bladder back to the donor.

[0019] In at least one exemplary embodiment, the first blood component may include plasma, and the second blood component may include platelets. In at least one exemplary embodiment, the draw pump may be disengaged when the return pump returns the separated first blood component through the second tube to the blood component separation bladder and moves at least the third blood component from the blood component separation bladder back to the donor. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a filler that rotates the blood component separation bladder in the centrifuge. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a separation insertion channel formed in the filler.

[0020] In at least one exemplary embodiment, the present disclosure provides a filler for holding a separation bladder from which components are separated. The filler comprises a channel for holding the separation bladder during the separation of components from the complex fluid, the channel comprising a first wall and a second wall opposite the first wall, the first end of the channel adjacent to the center of the filler, and the channel being helical toward the outer circumference of the filler.

[0021] In at least one exemplary embodiment, the top of the channel may be narrower than the central portion of the channel. In at least one exemplary embodiment, at least a portion of the second wall may have a concave surface. In at least one exemplary embodiment, the second end of the channel may be positioned to receive a higher gravitational force than the first end during separation. In at least one exemplary embodiment, the top of the channel may be positioned to provide reinforcement to the separation bladder during separation.

[0022] In at least one exemplary embodiment, the Disclosure provides a fluid separation filler, the fluid separation filler comprising a body having a pivot axis positioned substantially at the center of mass of the body, and a fluid separation insertion channel disposed within the body and following a substantially helical path extending spirally outward from a first point near the pivot axis to a second point positioned near the outer circumference of the body, wherein the fluid separation insertion channel curves outward toward the circumferential portion of the body near the end of the substantially helical path defining a third point of the fluid separation insertion channel furthest from the pivot axis.

[0023] In at least one exemplary embodiment, the fluid separation filler may further comprise a fluid collection chamber located within the body and following a substantially helical path, the fluid separation insertion channel connecting to the fluid collection chamber and defining an access area between the inside of the fluid collection chamber and the outside of the body. In at least one exemplary embodiment, the fluid collection chamber may be configured to receive a disposable fluid separation bladder. In at least one exemplary embodiment, the dimension from the rotation axis to the third point of the substantially helical path may be greater than the dimension from the rotation axis to the second point of the substantially helical path. In at least one exemplary embodiment, the width of the fluid collection chamber at a point along the substantially helical path may be greater than the width of the fluid separation insertion channel at a point along the substantially helical path. In at least one exemplary embodiment, the fluid collection chamber may further include a first wall following the innermost portion of the substantially helical path and a second wall substantially parallel to the first wall and following the outermost portion of the substantially helical path. In at least one exemplary embodiment, the fluid collection chamber may further include one or more tapered walls positioned between the first wall and the second wall, the one or more tapered walls being configured to guide the disposable fluid separation bladder to a seated position within the fluid collection chamber. In at least one exemplary embodiment, the fluid inlet for the disposable fluid separation bladder, when installed in the fluid collection chamber, is located adjacent to the rotation axis, and the first fluid path of the disposable fluid separation bladder follows the substantially helical path outward toward the end of the disposable fluid separation bladder located adjacent to the third point of the fluid separation insertion channel located furthest from the rotation axis, and is fluidically interconnected with a second fluid path that is separated from the first fluid path of the disposable fluid separation bladder and extends inward from the third point along the substantially helical path toward the fluid outlet for the disposable fluid separation bladder located adjacent to the rotation axis.In at least one exemplary embodiment, the fluid inlet and the fluid outlet may be part of a connector attached to the disposable fluid separation bladder, and the body of the fluid separation filler may include a connection point that engages with the connector. In at least one exemplary embodiment, the connector may include at least one keying function portion, and the connection point may include at least one mating keying function portion, the keying function portion may securely position the connector relative to the connection point.

[0024] In at least one exemplary embodiment, the Disclosure provides a centrifugal separator assembly comprising: a centrifugal separator housing having an internal cavity and rotating about an axis of rotation of the centrifugal separator assembly; and a fluid separator body at least partially located within the internal cavity of the centrifugal separator housing and configured to rotate relative to the centrifugal separator housing about an axis of rotation, the fluid separator body including a fluid separator insertion channel located within the fluid separator body and following a substantially helical path extending spirally outward from a first point adjacent to the axis of rotation to a second point located adjacent to the outer circumference of the fluid separator body, the fluid separator insertion channel curving outward toward the outer circumference of the body near the end of the substantially helical path defining a third point of the fluid separator insertion channel located furthest from the axis of rotation.

[0025] In at least one exemplary embodiment, the fluid separation body further comprises a fluid collection chamber located within the body and following a portion of the substantially helical path, and the fluid separation insertion channel may be connected to the fluid collection chamber to define an access area between the inside of the fluid collection chamber and the outside of the fluid separation body. In at least one exemplary embodiment, the centrifuge assembly further comprises a disposable fluid separation bladder located within the fluid collection chamber and following a substantially helical path, the disposable fluid separation bladder including a fluid inlet located adjacent to the rotation axis, and a first fluid path of the disposable fluid separation bladder following a substantially helical path outward toward the end of the disposable fluid separation bladder located adjacent to the third point of the fluid separation insertion channel located furthest from the rotation axis, and is fluidically interconnected with a second fluid path separated from the first fluid path of the disposable fluid separation bladder and extending inward from the third point along a substantially helical path toward a fluid outlet for the disposable fluid separation bladder located adjacent to the rotation axis. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis apparatus. In at least one exemplary embodiment, the centrifuge housing may be divided into an upper housing and a lower housing, the upper housing including an internal cavity, the upper housing being rotatable between an open and closed state about a pivot axis offset with respect to the rotation axis and substantially perpendicular to the rotation axis, and the fluid separation insertion channel of the fluid separation body may be accessible in the open state and inaccessible in the closed state.

[0026] In at least one exemplary embodiment, the present disclosure provides a blood component collection loop. The blood component collection loop includes a flexible loop, a system-fixed loop connector disposed at a first end of the flexible loop, the system-fixed loop connector being connected to a fixed loop connection portion of a centrifuge so as to fix the first end of the flexible loop to rotate integrally with the centrifuge, a filler loop connector disposed at a second end opposite to the first end of the flexible loop, the filler loop connector being connected to a loop connection region of a filler, and torsional force based on torsion in the flexible loop being applied to the filler via the filler loop connector. The flexible loop is moved in a rotational direction so as to be captured by a loop rotation positioning guide located in the centrifuge.

[0027] In at least one exemplary embodiment, the blood component collection loop may be part of a blood component collection set, which may be associated with an apheresis system. In at least one exemplary embodiment, the loop rotation positioning guide may be mounted on a rotor that rotates the loop rotation positioning guide and the flexible loop around a rotation axis. In at least one exemplary embodiment, the blood component collection loop may be at least partially positioned by a loop positioning stopper plate. In at least one exemplary embodiment, the flexible loop may be curved around the centrifuge. In at least one exemplary embodiment, the flexible loop may also be held in place by a loop storage bracket. In at least one exemplary embodiment, at least a portion of the loop rotation positioning guide may include a loop torsion support bearing. In at least one exemplary embodiment, the loop torsion support bearing may include a pair of roller bearings. In at least one exemplary embodiment, the loop torsion support bearing may allow the flexible loop to twist. In at least one exemplary embodiment, the twisting may cause the filler to rotate at an angular velocity greater than that of the centrifuge. In at least one exemplary embodiment, the flexible loop may include two or more lumens for moving whole blood and / or blood components within the flexible loop.

[0028] In at least one exemplary embodiment, the Disclosure provides an assembly for mounting a flexible loop. The assembly comprises a loop rotation positioning guide having a channel for holding a flexible loop of a blood component collection set; a loop torsion support bearing positioned within the channel in a portion of the loop rotation positioning guide to support the flexible loop; and a loop capture arm, the loop capture arm positioned adjacent to the channel and connected to the loop rotation positioning guide, guiding the flexible loop into the channel and in contact with the loop torsion support bearing.

[0029] In at least one exemplary embodiment, the assembly may be part of an apheresis device, and the loop rotation positioning guide may be attached to a centrifuge that rotates the loop rotation positioning guide and the flexible loop around an axis of rotation. In at least one exemplary embodiment, the loop rotation positioning guide may further include a loop positioning stopper plate for further positioning the flexible loop. In at least one exemplary embodiment, the assembly may further include a loop storage bracket positioned in the same plane as the loop rotation positioning guide and disposed on the centrifuge to further capture the flexible loop.

[0030] In at least one exemplary embodiment, the present disclosure provides a method for automatically attaching a flexible loop to an assembly. The method includes connecting a system-fixed loop connector disposed at a first end of the flexible loop to a fixed loop connection portion of a centrifuge to fix the first end of the flexible loop to rotate integrally with the centrifuge; connecting a filler loop connector disposed at a second end opposite to the first end of the flexible loop to a loop connection region of a filler, wherein a torsional force based on the torsion of the flexible loop is applied to the filler via the filler loop connector; and moving the flexible loop in a rotational direction to a loop rotation positioning guide positioned on the centrifuge.

[0031] In at least one exemplary embodiment, the flexible loop may engage with a loop torsion support bearing positioned within a channel formed by the loop rotation positioning guide, the loop torsion support bearing supporting the flexible loop. In at least one exemplary embodiment, a loop capture arm may contact the flexible loop when rotating it to guide it into the channel and into contact with the loop torsion support bearing. In at least one exemplary embodiment, the loop rotation positioning guide may further include a loop positioning stopper plate to prevent the flexible loop from over-rotating beyond the channel. In at least one exemplary embodiment, a loop storage bracket positioned coplanar with the loop rotation positioning guide and positioned on the centrifuge may further capture and hold the flexible loop.

[0032] In at least one exemplary embodiment, the present disclosure provides a soft cassette, the soft cassette comprising a first cassette port, a second cassette port, a DC lumen fluidly connected to the first and second cassette ports, a drip chamber, the drip chambers being arranged toward each other within the DC lumen such that fluid passing through the DC lumen passes through the drip chambers, and a fluid flow bypass path, the fluid flow bypass path being fluidly connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chambers, and fluidly connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chambers, such that fluid flowing through the fluid flow bypass path bypasses the drip chambers.

[0033] In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch adjacent to the first cassette port and fluid-connected to the DC lumen, and a second bypass branch adjacent to the second cassette port and fluid-connected to the DC lumen. In at least one exemplary embodiment, the fluid flow bypass path may further include a fluid pressure ring positioned between the first and second bypass branches and fluid-connected to these bypass branches. In at least one exemplary embodiment, the DC lumen may have a first flexible region positioned between a first connection to the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to close the DC lumen. In at least one exemplary embodiment, the DC lumen may have a second flexible region located between the second connection to the second bypass branch and the drip chamber, the second flexible region allowing a second fluid control valve to close the DC lumen. In at least one exemplary embodiment, the DC lumen includes a third flexible region located within the first bypass branch, the third flexible region allowing a draw-in fluid control valve to close the first bypass branch. In at least one exemplary embodiment, the first cassette port may be fluid-connected to a cassette inlet tube that moves fluid from a donor to the soft cassette or from the soft cassette to the donor, and the second cassette port may be fluid-connected to a loop inlet tube that moves fluid from the soft cassette to a centrifuge or from the centrifuge to the soft cassette. In at least one exemplary embodiment, when drawing fluid from the donor, the fluid may pass through the fluid flow bypass path. In at least one exemplary embodiment, when the fluid is delivered to the donor, the fluid may pass through the DC lumen. In at least one exemplary embodiment, when the fluid is drawn from the donor in the next draw, some of the fluid previously delivered to the donor through the DC lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass path.In at least one exemplary embodiment, the soft cassette may be part of a blood component collection set. In at least one exemplary embodiment, the blood component collection set may be part of an apheresis system.

[0034] In at least one exemplary embodiment, the present disclosure provides a blood component collection set. The blood component collection set comprises a centrifuge for separating blood components from whole blood, a cassette inlet tube fluidly connected to a donor, a loop inlet tube fluidly connected to the centrifuge, and a soft cassette, the soft cassette comprising a first cassette port fluidly connected to the cassette inlet tube, a second cassette port fluidly connected to the loop inlet tube, a DC lumen fluidly connected to the first and second cassette ports, a drip chamber disposed within the DC lumen such that fluid passing through the DC lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chamber, and fluidly connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0035] In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch adjacent to the first cassette port and fluidly connected to the DC lumen, a second bypass branch adjacent to the second cassette port and fluidly connected to the DC lumen, and a fluid pressure ring positioned between the first and second bypass branches and fluidly connected to these bypass branches. In at least one exemplary embodiment, the DC lumen may include a first flexible region located between a first connection to the first bypass branch and the drip chamber, the first flexible region allowing a first fluid control valve to close the DC lumen; the DC lumen may include a second flexible region located between a second connection to the second bypass branch and the drip chamber, the second flexible region allowing a second fluid control valve to close the DC lumen; and the DC lumen may include a third flexible region located within the first bypass branch, the third flexible region allowing a draw-in fluid control valve to close the first bypass branch. In at least one exemplary embodiment, when fluid is drawn in from the donor, the first and second fluid control valves may be closed to close the DC lumen, and the draw-in fluid control valve may be opened to allow whole blood to pass through the fluid flow bypass path. In at least one exemplary embodiment, when fluid is supplied to the donor, the first and second fluid control valves may be opened to allow the fluid to pass through the DC lumen, and the intake fluid control valve may be closed to block the fluid flow bypass path. In at least one exemplary embodiment, when fluid is drawn from the donor in the next intake, some of the fluid previously supplied to the donor through the DC lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass path.

[0036] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a soft cassette. The method is a step of preparing a soft cassette, the soft cassette comprising a first cassette port fluid-connected to a cassette inlet tube, a second cassette port fluid-connected to a loop inlet tube, a DC lumen fluid-connected to the first and second cassette ports, a drip chamber, the drip chambers being arranged in relation to each other within the DC lumen such that fluid passing through the DC lumen passes through the drip chambers, and a fluid flow bypass path, the fluid-connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chambers, and the fluid-connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chambers, such that fluid flowing through the fluid flow bypass path bypasses the drip chambers. A method comprising a fluid flow bypass path fluidly connected to a DC lumen, further comprising, when drawing whole blood from a donor, the steps of receiving whole blood from the cassette inlet tube at a first cassette port fluidly connected to the cassette inlet tube, moving the whole blood through the fluid flow bypass path to a second cassette port, and preventing the whole blood from moving through the DC lumen; and when returning red blood cells to a donor, the steps of receiving red blood cells from the loop inlet tube at a second cassette port fluidly connected to the loop inlet tube, moving the red blood cells through the DC lumen and the drip chamber to a first cassette port, and preventing the red blood cells from moving through the fluid flow bypass path.

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

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

[0039] One or more means configured to carry out one or more of the embodiments / models substantially disclosed herein.

[0040] This disclosure may offer many advantages depending on the particular aspect, embodiment, and / or configuration. By maintaining the centrifuge rotation speed while transferring and returning unnecessary blood components to the donor, the apheresis procedure time can be reduced by up to 30% in some cases. This increased efficiency enables faster and more comfortable donor donation. Faster donor donation times allow donor donation centers to obtain more donor donations in a typical day, increasing productivity and revenue. Furthermore, faster donor donations make donors more likely to return for further donations. Faster donor donations also allow donor donation centers to attract donors who are currently using other donor donation centers with slower donation rates.

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

[0042] The term “one (a)” or “one (an)” + existence refers to one or more such existences. Accordingly, the terms “one (a)” (or “one (an)”), “one or more (one or more)” and “at least one” may be used interchangeably in this specification. It should also be noted that the terms “comprising,” “including,” and “having” may be used interchangeably.

[0043] As used herein, the term “donor” may mean any person who provides a fluid, such as whole blood, to an apheresis system. The donor may also be a patient who temporarily provides a fluid to the apheresis system, which is processed, treated, manipulated, etc., before being returned to the patient.

[0044] As used herein, the term “automatic” and its variations refer to any process or action that is performed without substantial human input when it is performed. However, even if significant or unsignificant human input is used in the execution of a process or action, the process or action may be automatic if such input is received before the execution of the process or action. Human input is considered significant if it affects how the process or action is performed. Human input that signifies consent to the execution of a process or action is not considered “significant.”

[0045] As used herein, the term “computer-readable medium” refers to any tangible storage device and / or transmission medium involved in providing instructions to a processor for execution. Such mediums can take many forms, but are not limited to non-volatile media, volatile media, and transmission media. Examples of non-volatile media include NVRAM, magnetic disks, or optical disks. Examples of volatile media include dynamic memory such as main memory. Common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tapes, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tapes, any other physical media with hole patterns, RAM, PROMs, and EPROMs, FLASH-EPROMs, solid media such as memory cards, any other memory chips or cartridges, carriers as described below, or any other computer-readable media. Digital files or other embedded information archives or sets of archives attached to email are considered distribution media equivalent to tangible storage media. When a computer-readable medium is configured as a database, it should be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and / or similar. Accordingly, this disclosure is considered to include tangible storage media or distribution media on which a software implementation of the disclosure is stored, as well as equivalents and successor media recognized as prior art.

[0046] As used herein, the term “module” refers to any known or subsequently developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software capable of performing functions associated with such elements.

[0047] The terms “determine,” “calculate,” and “operate” as used herein, and their variations thereof, are to be used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0048] The term “means” as used herein should be understood to be given its broadest possible interpretation in accordance with paragraph 6 of Section 112 of 35 U.S.C. Accordingly, any claim containing the term “means” shall encompass all structures, materials, or actions and all equivalents thereof described herein. Furthermore, structures, materials, or actions and their equivalents shall include all those described in the summary of the invention, the brief description of the drawings, the detailed description, the abstract, and the claims themselves.

[0049] The above is a simplified overview of the Disclosure to give an understanding of some aspects of the Disclosure. This overview is neither an extensive nor a comprehensive overview of the Disclosure and its various aspects, embodiments, and / or configurations. It does not attempt to identify important or significant elements of the Disclosure, nor to delineate the scope of the Disclosure, but rather to provide a simplified form of selected concepts of the Disclosure as an introduction to the more detailed description provided below. As can be understood, other aspects, embodiments, and / or configurations of the Disclosure are possible that utilize one or more of the features described above or described below, either individually or in combination. [Brief explanation of the drawing]

[0050] [Figure 1] Figure 1 is a perspective view of the operating environment of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 2A] Figure 2A is a perspective view of the apheresis system shown in Figure 1. [Figure 2B] Figure 2B is a perspective view of an exemplary pump used in the apheresis system of Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 2C] Figure 2C is another perspective view of the exemplary pump shown in Figure 2B. [Figure 2D]Figure 2D is a perspective view of an exemplary fluid valve control system used in the apheresis system of Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 3A] Figure 3A is a perspective view of an exemplary disposable soft cassette assembly used in the apheresis system of Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 3B] Figure 3B is another perspective view of the exemplary disposable soft cassette shown in Figure 3A. [Figure 3C] Figure 3C is an elevation cross-sectional view along line 3C in Figure 3B. [Figure 3D] Figure 3D is an elevation cross-sectional view along line 3D in Figure 3B. [Figure 4A] Figure 4A is a perspective view of an exemplary centrifuge assembly used in the apheresis system of Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 4B] Figure 4B is a front perspective view of the centrifuge assembly shown in Figure 4A. [Figure 4C] Figure 4C is a rear perspective view of the centrifuge assembly shown in Figure 4A. [Figure 4D] Figure 4D is a schematic cross-sectional view of the centrifuge assembly of Figure 4A in a closed state, according to at least one exemplary embodiment of the present disclosure. [Figure 4E] Figure 4E is a schematic cross-sectional view of the partially open centrifuge assembly of Figure 4A, according to at least one exemplary embodiment of the present disclosure. [Figure 4F] Figure 4F is a schematic cross-sectional view of the centrifuge assembly of Figure 4A in an open state, according to at least one exemplary embodiment of the present disclosure. [Figure 4G] Figure 4G is a perspective view of an exemplary filler used in the centrifuge of Figure 4A, according to at least one exemplary embodiment of the present disclosure. [Figure 4H] Figure 4H is a plan view of the exemplary filler shown in Figure 4G. [Figure 4I]Figure 4I is a schematic plan view of a substantially helical receiving channel used in the filler shown in Figure 4G, according to at least one exemplary embodiment of the present disclosure. [Figure 4J] Figure 4J is an elevation cross-sectional view along line 4J in Figure 4H. [Figure 4K] Figure 4K is a detailed cross-sectional view of a portion of the channel in the filler shown in Figure 4G. [Figure 4L] Figure 4L shows different states of the fluid separation bladder placed within the channel in the filler of Figure 4G. [Figure 5A] Figure 5A is a schematic diagram of an exemplary fluid component collection set for use in, for example, the exemplary apheresis system shown in Figure 1, according to an embodiment of the present disclosure. [Figure 5B] Figure 5B is an elevation view of the fluid component collection loop shown in Figure 5A. [Figure 5C] Figure 5C is a cross-sectional view of an exemplary bladder used in the fluid component collection loop of Figure 5A, according to at least one exemplary embodiment of the present disclosure. [Figure 5D] Figure 5D is a cross-sectional view of another exemplary bladder used in the fluid component collection loop of Figure 5A, according to at least one exemplary embodiment of the present disclosure. [Figure 5E] Figure 5E is a perspective view of the fluid component collection loop of Figure 5A in a bent state, according to at least one exemplary embodiment of the present disclosure. [Figure 5F] Figure 5F is a perspective view of the fluid component collection loop of Figure 5A in a mounted state, according to at least one exemplary embodiment of the present disclosure. [Figure 5G] Figure 5G is a perspective view of an exemplary fluid component collection loop shown in Figure 5A, which is fitted to, for example, an exemplary filler shown in Figure 4G, according to at least one exemplary embodiment of the present disclosure. [Figure 5H] Figure 5H is a perspective view of the exemplary fluid component collection loop shown in Figure 5A, fitted to, for example, the exemplary filler shown in Figure 4G, according to at least one exemplary embodiment of the present disclosure. [Figure 6A]Figure 6A is a schematic cross-sectional view of the centrifuge assembly of Figure 4A in a first loop-mounted state, according to at least one exemplary embodiment of the present disclosure. [Figure 6B] Figure 6B is a schematic cross-sectional view of the centrifuge assembly of Figure 4A in a second loop-mounted state according to at least one exemplary embodiment of the present disclosure. [Figure 6C] Figure 6C is a schematic cross-sectional view of the centrifuge assembly of Figure 4A in a third loop mounting state according to at least one exemplary embodiment of the present disclosure. [Figure 7A] Figure 7A is a schematic plan view of the centrifuge assembly of Figure 4A with the loop mounted, according to at least one exemplary embodiment of the present disclosure. [Figure 7B] Figure 7B is a schematic plan view of the centrifuge assembly of Figure 4A in operation, according to at least one exemplary embodiment of the present disclosure. [Figure 8] Figure 8 is a functional diagram of an exemplary apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 9] Figure 9 is a block diagram of the electrical system of the apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 10] Figure 10 is a further block diagram of the exemplary electrical system shown in Figure 9. [Figure 11] Figure 11 is a further block diagram of the exemplary electrical system shown in Figure 9. [Figure 12] Figure 12 is a process diagram of an exemplary method for performing apheresis using, for example, the apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 13] Figure 13 is a process diagram of another exemplary method for performing apheresis using, for example, the apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 14]Figure 14 is a process diagram of another exemplary method for performing apheresis using, for example, the apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 15] Figure 15 is a process diagram of another exemplary method for performing apheresis using, for example, the apheresis system shown in Figure 1, according to at least one exemplary embodiment of the present disclosure. [Figure 16] Figure 16 is a process diagram of an exemplary method for inserting a disposable item into a filler similar to the filler shown in Figure 4G, according to at least one exemplary embodiment of the present disclosure. [Figure 17A] Figure 17A is an exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17B] Figure 17B is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17C] Figure 17C is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17D] Figure 17D is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17E] Figure 17E is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17F] Figure 17F is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17G] Figure 17G is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17H] Figure 17H ​​is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17I] Figure 17I is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17J] Figure 17J is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17K] Figure 17K is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17L] Figure 17L is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17M] Figure 17M is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17N] Figure 17N is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17O]Figure 17O is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17P] Figure 17P is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17Q] Figure 17Q is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17R] Figure 17R is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17S] Figure 17S is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17T] Figure 17T is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in Figure 1, during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0051] In the attached diagram, similar components and / or features may have the same reference label. Furthermore, different components of the same type may be distinguished by letters following the reference label that differentiate them from each other. If only the initial reference label is used in the specification, its description can be applied to any one of the similar components having the same initial reference label, regardless of any subsequent reference labels.

[0052] Embodiments of this disclosure are described in relation to apheresis methods and systems. The following embodiments are described with respect to the separation of blood components from whole blood. However, these are given for illustrative purposes only. The embodiments are not limited to the following description. The embodiments are intended for use in products, processes, apparatus, and systems for separating any complex fluid. Accordingly, this disclosure is not limited to the separation of blood components from whole blood.

[0053] Figure 1 shows a perspective view of the operating environment 100 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes the apheresis system 200, a donor 102, and one or more connections (e.g., a donor supply tube 104, a cassette inlet tube 108A, 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 of the donor 102, e.g., a vein, via venipuncture. For example, a cannula connected to the end of the donor supply tube 104 is inserted through the skin of the donor 102 and inserted into a target site (e.g., a vein). This connection provides a venous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the original donor 102. In at least one exemplary embodiment, the fluid pathways and connection portions may form an extracorporeal tubular circuit of the apheresis system 200.

[0054] Blood supplied from donor 102 flows along donor supply tube 104 through tube connector 106 and into soft cassette assembly 300 along cassette inlet tube 108A. The soft cassette assembly 300 may include one or more fluid control paths and valves for selectively controlling the flow of blood to and / or from donor 102. The apheresis system 200 may include an anticoagulant supply source contained in anticoagulant (AC) bag 114. The anticoagulant may also be delivered through at least anticoagulant tube 110 and tube connector 106 to prevent blood clotting in the apheresis system 200.

[0055] The anticoagulant may include, but is not limited to, one or more citrates and / or unfractionated heparin. The AC bags and other bags or bottles described herein may be formed from, but are not limited to, one or more of the following: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The amount of AC in the AC bag 114 may vary based on various factors, including the weight of the donor 102 and the volumetric flow rate of blood from the donor. In one example, the volume in the AC bag 114 is 250 mL to 500 mL, but the volume in the AC bag 114 may be greater or less than this volume.

[0056] In at least one embodiment, the apheresis system 200 may include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or tubes 116, 120 (e.g., fluid transport tubes) connecting the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200. The amount of saline fluid provided in the saline bag 118 is, for example, about 500 mL to 800 mL, but the volume of the saline bag 118 may be larger or smaller than this volume. An example of the amount of blood component (e.g., plasma) to be donated may be 880 mL. Therefore, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one exemplary embodiment, the plasma collection bottle 122 may include a connection point located substantially at, adjacent to, or physically close to the bottom of the plasma collection bottle 122 (for example, when the plasma collection bottle 122 is placed in the plasma collection cradle 232C, as shown in Figure 2A). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 for receiving and / or transporting plasma. Placing the connection point at the bottom of the plasma collection bottle 122 allows the plasma contained in the plasma collection bottle 122 to flow back from the plasma tube 120 through the line without trapping air bubbles, as described herein. In at least one exemplary embodiment, the plasma collection bottle 122 may be configured as a flexible bag, a rigid container, and / or other container, and therefore the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0057] Figure 2A shows a perspective view of the apheresis system 200 described in Figure 1. The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is collected from donor 102 and supplied substantially continuously to the blood component separator of the apheresis system 200. In the blood component separator, the blood is separated into various components, and at least one of these blood components is collected from the apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components may be collected for subsequent use or returned to donor 102. Blood is collected from donor 102 and guided to the centrifuge of the apheresis system 200 through the opening 220 of the access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the tubes 104, 108A, 108B, 112, 116, and 120 used in the extracorporeal tubing circuit form a closed-system sterile disposable system or blood component collection set, which is further described below.

[0058] Examples of apheresis systems, plasmapheresis systems, and other separation systems that may be used in conjunction with embodiments of the present disclosure (such as the apheresis system 200) include, but are not limited to, the SPECTRA OPTIA® apheresis system, the COBE® spectral apheresis system, and the TRIMA ACCEL® automated blood collection system (these systems are manufactured by Terumo BCT in Lakewood, Colorado).

[0059] The operation of various pumps, valves, and blood component separators or centrifuges may be controlled by one or more processors included in the apheresis system 200. One or more processors may include, for example, multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, and / or flash memory), communication / network devices (e.g., wired such as modems / network cards, or wireless such as WiFi), keyboards, touchscreens, cameras, and / or input devices such as microphones, and output devices for displays and / or audio systems. To assist the operator of the apheresis system 200 in various aspects of its operation, embodiments of the blood component separator or centrifuge may include a graphical user interface with a display, including an interactive touchscreen.

[0060] The apheresis system 200 may include a housing 204 and / or a structural frame, a cover 210, access panels 224 located at the front 202 and / or rear 206 of the apheresis system 200, and one or more supports 232A-232C including hooks, rests, cradles, arms, projections, plates, and / or other support functions for holding, placing, and / or otherwise supporting bags or containers 114, 118, 122. In at least one exemplary embodiment, the functional parts of the apheresis system 200 are described in relation to a coordinate system 103 and / or one or more axes thereof. The housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extruded materials, and / or beams) to which one or more panels, covers 210, doors, subassemblies, and / or components are attached. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may include a mounting surface for a soft cassette assembly 300, one or more pumps 208, 212, 216, and / or a fluid valve control system 228 (e.g., plasma-saline valve control).

[0061] The access panel 224 may include one or more handles, locks, and pivot or hinge shafts 226 (e.g., door hinges, piano hinges, continuous hinges, and / or cleanroom hinges). In any case, the access panel 224 is selectively opened to allow access to the interior of the apheresis system 200, more specifically, to the blood separation assembly or centrifuge. In at least one exemplary embodiment, the access panel 224 allows access to the interior when attaching and / or removing one or more components of the blood component collection set to the centrifuge.

[0062] The interior of the apheresis system 200 may be divided into at least a centrifugation section and a control section. For example, the centrifugation section includes a cavity configured to accommodate a centrifuge, a rotary motor, and associated hardware. This area may be physically separated from the control section by one or more walls of the cavity. In at least one exemplary embodiment, access to the control section (configured to house or include, for example, a motor controller, a CPU or processor, electronics, and / or wiring) may be provided by a panel separate from the rigidly fastened panel of the housing 204 and / or the access panel 224.

[0063] In at least one exemplary embodiment, the apheresis system 200 includes a plurality of pumps 208, 212, 216 configured to control the flow of fluid (e.g., blood and / or blood components, anticoagulants, and / or saline) through the apheresis system 200. For example, the apheresis system 200 includes a draw pump 208 that controls blood flow to and / or from the donor 102 to the centrifuge of the apheresis system 200. The draw pump 208 may engage with a portion of the loop inlet tube 108B located between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 may include a return pump 212 configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to and / or the reverse flow to the plasma collection bottle 122. In addition to or instead of this, the return pump 212 may control the flow of saline (supplied, for example, from the saline bag 118) throughout the blood component collection set and / or apheresis system 200. The anticoagulant pump 216 may engage with a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant throughout the blood component collection set of the apheresis system 200. As shown in Figure 2A, the pumps 208, 212, and 216 may be at least partially located on the top cover 210 of the apheresis system 200.

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

[0065] The suction pump 208 may include a pump cover 236 or housing configured to at least partially accommodate the moving elements of the suction pump 208. In at least one exemplary embodiment, the pump cover 236 may include a hinged tube guard 240 configured to open and close around a tube guard pivot axis 242. In at least one exemplary embodiment, the tube guard 240 may be attached to the pump cover 236 via one or more fasteners arranged along the tube guard pivot axis 242. As shown in Figures 2B and 2C, the blood supplied by the donor 102 may be transported or drawn into the centrifuge by the suction pump 208 in a first suction direction, i.e., the centrifuge direction 250A. In addition to or instead of this, blood or other fluid may be transported or drawn into the donor 102 by the suction pump 208 in a donor direction 250B opposite to the centrifuge direction 250A.

[0066] In at least one exemplary embodiment, the intake pump 208 and / or other pumps 212, 216 may be tube pumps, peristaltic pumps, diaphragm pumps, and / or other pumps configured to manipulate the flow of fluid (e.g., blood, blood components, anticoagulants, and / or saline) in at least a portion of the tubing. For example, pumps 208, 212, 216 may include motors operably interconnected with the rotating tube contact assembly. During operation, the tubing (e.g., loop inlet tube 108B, loop outlet tube 112, and / or anticoagulant tube 110) may be inserted into the lead 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 may be moved away from the rotating tube contact head or pumps 208, 212, 216 to provide an intake clearance area, or vice versa. The rotating tube contact head comprises a plurality of rotating pressure rollers 268, each roller configured to rotate around its respective pressure roller rotation axis 264. Each of the rotating pressure rollers 268 is positioned between a first rotating pump plate 272A and a second rotating pump plate 272B, in which case the plates 272A and 272B are configured to rotate around the pump rotation axis 260. In at least one exemplary embodiment, the rotating pressure rollers 268 are positioned on the outer circumference of the rotating pump plates 272A and 272B.

[0067] One or more of pumps 208, 212, and 216 may, without limitation, include or operate similarly to the Pulsafeeder® Model UX-74130 peristaltic pumps and Pulsafeeder® MEC-O-MATIC series pumps, all manufactured by Pulsafeeder Inc. in Punta Gorda, Florida. Other examples of pumps 208, 212, and 216 include, but are not limited to, the INTEGRA DOSE IT Laboratory peristaltic pumps manufactured by INTEGRA Biosciences AG in Switzerland, and the WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pumps, all manufactured by WELCO Co., Ltd. in Tokyo, Japan.

[0068] When the tube is mounted on the lead tube guide 244, the tube pressure block 248, and / or the end tube guide 252, at least a portion of the rotary pressure roller 268 engages with, contacts, or presses against the tube positioned between the rotary tube contact head and the tube pressure block 248. As the rotary pump plates 272A and 272B rotate around the pump rotation axis 260, the rotary pressure roller 268 compresses the portion of the tube between the pumps 208, 212, and 216 and the tube pressure block 248, ensuring that the fluid in that portion of the tube is moved in the direction 250A and 250B in which the rotary pressure roller 268 moves. For example, if the rotary pump plates 272A and 272B rotate counterclockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268 compressing the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or deliver the fluid towards the centrifuge 250A. As another example, when the rotary pump plates 272A and 272B rotate clockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268, which compresses the tube between the rotary pressure roller 268 and the tube pressure block 248, can move or deliver the fluid in the donor direction 250B. When not actively delivering fluid, the pump 208 is maintained in a state where at least one rotary pressure roller 268 continues to occlude the tube 108B, or where the rotary pressure roller 268 does not occlude the tube 108B. Thus, the pump 208 can also act as a "valve" to prevent or allow fluid movement based on its stationary state. This capability is also possible in pumps 212 and 216.

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

[0070] One or more fluid control valves can be used to control the routing or flow direction of the fluid being transported through the tubing of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 may include a plasma-saline valve control system 228 positioned adjacent to the saline bag 118 and / or plasma collection bottle 122. The plasma-saline valve control system 228 is shown in a detailed perspective view in Figure 2D.

[0071] As shown in Figure 2D, the loop outlet tube 112 passes through the return pump 212 and is interconnected with the saline-plasma tube y-connector 280. The saline-plasma tube y-connector 280 allows the loop outlet tube 112 to be connected to the saline tube 116 line and the plasma tube 120 line. The plasma-saline valve control system 228 includes an air detection sensor 284 located at the first end of the saline-plasma valve housing 276 and surrounding a portion of the loop outlet tube 112. For example, the air detection sensor 284 may be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air in the loop outlet tube 112 and providing a signal to the controller of the apheresis system 200. Examples of air detection sensor 284 include, for example, the SONOCHECK ABD05 manufactured by SONOTEC US Inc., or other similar sensors.

[0072] The saline / plasma valve housing 276 includes a plurality of receiving functions (e.g., grooves, channels, and / or receptacles) for receiving portions of the tubes 112, 116, 120 and / or the saline / plasma tube y-connector 280. When air is detected in the loop outlet tube 112, the plasma / saline valve control system 228 selectively activates one or more of the fluid control valves 286, 288. In at least one exemplary embodiment, detection of air via the air detection sensor 284 signals an operation step and / or triggers a step in a control method as described herein.

[0073] The plasma flow control valve 286 and / or saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamp valves, tubular valves, and / or other operable valves configured to selectively alter (e.g., block) the fluid passage associated with specific portions of the tubes 112, 116, and 120. As shown in Figure 2D, the plasma flow control valve 286 may be configured to pinch a portion of the plasma tube 120 that is at least partially housed within the receptive functional portion of the saline-plasma valve housing 276. The saline flow control valve 288 may be configured to pinch a portion of the saline tube 116 that is at least partially housed within the receptive functional portion of the saline-plasma valve housing 276. In any case, the control valves 286 and 288 include operable and extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the tube housed within the saline-plasma valve housing 276. The control valves 286 and 288 may completely pinch the tube (for example, completely restrict the flow of fluid through the tube), but it should be understood that they may also be partially actuated to a position that partially restricts the flow of fluid through a portion of the tube.

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

[0075] The soft cassette assembly 300 includes an air detection sensor 312, a fluid sensor 316, and one or more fluid control valves 320A-320C configured to control the path or direction of fluid flow through the soft cassette 340. In at least one exemplary embodiment, these components may be embedded in the cassette access door 304, the base plate, and / or as part of the housing 204 of the apheresis system 200. Similar to the guard closing functional part 254 described in association with Figures 2B-2C, the soft cassette assembly 300 may include one or more door closing functional parts 328. These functional parts 328 may include, but are not limited to, magnetic catches, projections, tabs and slots, and / or other connections. In at least one exemplary embodiment, the door closing functional part 328 may include a pressure contact surface configured to hold or at least partially position the soft cassette 340 within the soft cassette assembly 300.

[0076] Examples of valves 320A-320C include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamp valves, tube valves, and / or other actuated valves configured to selectively alter (e.g., block) a fluid passage (e.g., cross-sectional area) associated with a particular portion of the soft cassette 340. The soft cassette assembly 300 includes a first fluid control valve 320A configured to pinch a portion of the soft cassette 340 adjacent to the cassette inlet tube 108A. A second fluid control valve 320B may be configured to pinch a portion of the soft cassette 340 adjacent to the loop inlet tube 108B. A draw-in fluid control valve 320C may be configured to pinch a portion of the soft cassette 340 along a branch tube extending from a point adjacent to the cassette inlet tube 108A to a point adjacent to the loop inlet tube 108B. In any case, valves 320A to 320C include operable and extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the soft cassette 340 housed within the soft cassette assembly 300. Valves 320A to 320C may completely pinch the flow path within the soft cassette 340 (e.g., completely restrict the flow of fluid through this flow path), but it should be understood that valves 320A to 320C may also be partially actuated to a position that partially restricts the flow of fluid through a portion of the soft cassette 340.

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

[0078] Figures 3B to 3D show an exemplary soft cassette 340 according to at least one exemplary embodiment of the present disclosure. As previously stated, the soft cassette 340 may be part of a blood component collection set. For example, the soft cassette 340 may be a disposable component used in a blood separation method described herein. In at least one exemplary embodiment, the soft cassette 340 may be formed from a substantially flexible and / or pliable material. The flexible material may be chemically inert and / or able to withstand sterilization and cleaning operations, temperatures, and / or processing. The soft cassette 340 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In at least one exemplary embodiment, the soft cassette 340 may be molded, rotomolded, cast, injection molded, or formed from one or more of the aforementioned materials.

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

[0080] Blood supplied by donor 102 is guided along one or more channels located within the soft cassette 340. In at least one exemplary embodiment, blood is guided along a DC lumen 370 from a first cassette port 360A to a second cassette port 360B. In at least one exemplary embodiment, this channel guides blood through a drip chamber 354 of the soft cassette 340. In at least one exemplary embodiment, blood and / or other fluids returned to donor 102 are guided along a DC lumen 370 from the second cassette port 360B to the first cassette port 360A.

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

[0082] Controlling the flow path or guiding fluid within the soft cassette 340 involves activating fluid control valves 320A-320C of the soft cassette assembly 300, causing the valves to interact with various flexible regions 350A-350C to shut off and / or open multiple portions of the DC lumen 370 and / or bypass flow lumen 364. The first flexible region 350A provides a pinch valve region at a point along the DC lumen 370 between the first cassette port 360A near the first cassette end 342 of the soft cassette 340 and the drip chamber 354. When the first fluid control valve 320A is activated, the valve 320A pinches the DC lumen 370 in this first flexible region 350A, thereby restricting or completely blocking the fluid flow at this point in the soft cassette 340. The second flexible region 350B provides a pinch valve region at a point along the DC lumen 370 between the second cassette port 360B near the second cassette end 346 (e.g., the end opposite to the first cassette end 342) and the drip chamber 354. When the second fluid control valve 320B is actuated, the valve 320B pinches the DC lumen 370 in this second flexible region 350B, thereby restricting or completely blocking the fluid flow at this point in the soft cassette 340. As can be understood, a third flexible region 350C, positioned adjacent to the fluid pressure ring 362 and along the first bypass branch 358A, can provide a pinch valve region at a point along the bypass flow lumen 364. When the intake fluid control valve 320C is activated, the valve 320C can pinch the bypass flow lumen 364 in this third flexible region 350C, thereby restricting or completely blocking the flow of fluid through the bypass flow lumen 364.

[0083] As shown in the elevation section of Figure 3C, taken along a plane extending through the DC lumen 370 and the drip chamber 354, the DC lumen 370 extends from the first cassette port 360A through the chamber volume 374 of the drip chamber 354 to the second cassette port 360B. The DC lumen 370 is formed as a flow path extending inside the first tube section 368A, the chamber volume 374, and the second tube section 368B of the soft cassette 340.

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

[0085] Figures 4A to 4C show an exemplary centrifuge assembly 400 for use in an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 may be located within the internal space of the apheresis system 200. The internal space may be at least partially enclosed by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the internal space and the centrifuge assembly 400 may be provided by an access panel 224 located on the front 202 of the apheresis system 200. For example, the access panel 224 in Figure 4A is shown in an open position, open along a hinge axis 226. As previously stated, the hinge axis 226 may correspond to a door hinge, a continuous hinge, a cleanroom hinge, and / or any other panel hinge.

[0086] The centrifuge assembly 400 is operably mounted inside the apheresis system 200 so that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the apheresis system 200. One or more parts of the blood component collection set are loaded into the centrifuge assembly 400 by routing tubes (e.g., loop inlet tube 108B and / or loop outlet tube 112) into the internal space of the apheresis system 200 (e.g., through the opening 220 shown in Figure 2A), connecting a portion of the blood component collection loop 520 to the fixed loop connector 402, and inserting the blood component separation bladder 536 into the filler 460. The fixed loop connector 402 maintains the loop inlet tube 108B and loop outlet tube 112 in a fixed position and prevents the tubes 108B and 112 from twisting outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection loop 520 may be interconnected with the fixed loop connector 402 via one or more key function parts or positive location features.

[0087] The centrifuge assembly 400 includes a centrifuge split housing 404 having a lower housing 404A that is rotatably connected to an upper housing 404B. The upper housing 404B can be opened to provide access for loading a blood component separation bladder or other components of a blood component collection set into the centrifuge assembly 400. In at least one exemplary embodiment, the upper housing 404B rotates around a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, and / or shoulder bolt).

[0088] Each half of the centrifuge split housing 404 (e.g., the lower housing 404A and the upper housing 404B) may be configured to lock and / or unlock each other. Unlocking the upper housing 404B relative to the lower housing 404A provides access to the interior of the centrifuge assembly 400. This selective locking may be performed by rotating the upper housing 404B relative to the lower housing 404A around the centrifuge rotation axis 430. In Figures 4B and 4C, the centrifuge split housing 404 is shown in an unlocked state, but it should be understood that the upper housing 404B can be rotated (e.g., counterclockwise) around the centrifuge rotation axis 430 to engage one or more locking tabs 428 or locking elements of the upper housing 404B with locking slots 432 located in the lower housing 404A (as shown in Figure 4C). When the upper housing 404B is in the unlocked position, it is released or rotated around the split housing pivot axis 406 to mount the blood component collection loop 520 and / or blood component separation bladder 536 onto the centrifuge assembly 400. When the upper housing 404B is in the locked position, it is rotationally locked relative to the lower housing 404A, and the two halves of the centrifuge split housing 404 are locked together and rotate as a single unit during centrifugation or blood separation operations.

[0089] The centrifuge assembly 400 may include at least one clockwise rotation stopper 408A, a counterclockwise rotation stopper 408B, an upper housing clockwise rotation flag 410A, and / or an upper housing counterclockwise rotation flag 410B. In at least one exemplary embodiment, the rotation stoppers 408A, 408B are fixed in the rotational direction with respect to the centrifuge rotation axis 430 of the lower housing 404A. The rotation flags 410A, 410B are mounted on or formed in the upper housing 404B and are configured to contact the respective rotation stoppers 408A, 408B when locking and / or unlocking the two halves of the centrifuge split housing 404 to each other, thereby preventing over-rotation of the upper housing 404B relative to the lower housing 404A. For example, when the upper housing 404B is rotated clockwise or in the unlocking direction around the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A may contact the clockwise rotation stopper 408A to prevent further rotation in the clockwise direction. In addition to or instead of this, when the upper housing 404B is rotated counterclockwise or in the locking direction around the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation flag 410B may contact the counterclockwise rotation stopper 408B to prevent further rotation in the counterclockwise direction. In at least one exemplary embodiment, the centrifuge split housing 404 includes one or more locking elements. The locking elements are configured to hold half of the centrifuge split housing 404 in a locked state while these locking elements are engaged.

[0090] In at least one exemplary embodiment, the centrifuge split housing 404 includes a pull ring 412 attached to a portion of the upper housing 404B to rotate the upper housing 404B relative to the lower housing 404A around a split housing pivot axis 406. The pull ring 412 has an opening through which a user can insert a finger and apply a tensile force to the upper housing 404B, which is unlocked in the rotational direction.

[0091] The centrifuge assembly 400 may include a rotor motor assembly 414 that is controlled and / or powered via electrically interconnected electrical cables 420. The electrical cables 420 include connectors that are attached to a controller, processor, and / or power supply. The electrical cables 420 can transmit power and / or data signals between the rotor motor assembly 414 and one or more controllers / processors of the apheresis system 200. The rotor motor assembly 414 may be configured as an electric motor and / or as part of an electric motor that rotates the entire centrifuge assembly 400 relative to the apheresis system 200 (e.g., a portion of the housing 204 and / or the base of the apheresis system 200). In other words, the rotor motor assembly 414 includes one or more components that rotate the centrifuge assembly 400 (e.g., both halves of the centrifuge split housing 404 together) inside the apheresis system 200.

[0092] As described herein, the centrifuge assembly 400 may include one or more functional parts for guiding, housing, and / or positioning elements of a blood component collection set relative to the centrifuge split housing 404. For example, Figure 4B shows a blood component collection loop 520 captured in the operating position within a loop rotation positioning guide 424, which includes a loop capture arm 416. The loop rotation positioning guide 424 includes a plurality of bearings 417 and / or bearing surfaces arranged to at least partially support the blood component collection loop 520 in the operating position. In the operating position, the blood component collection loop 520 is capable of twisting along its length within the range of support provided by the bearings 417 of the loop rotation positioning guide 424. For example, one end of the blood component collection loop 520 is attached and fixed to a fixed loop connection 402 of the apheresis system 200, while the other end of the blood component collection loop 520 is attached to a filler 460 (e.g., an internal rotating component of the centrifuge assembly 400). As the centrifuge assembly 400 rotates during centrifugal operation, the twisting of the blood component collection loop 520 between the fixed loop connector 402 and the connector in the filler 460 causes the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In at least one exemplary embodiment, the low inertia of the filler 460, coupled with the twisting of the blood component collection loop 520 as the centrifuge assembly 400 rotates within the apheresis system 200, causes the filler 460 to rotate in the same direction at an angular velocity twice that of the centrifuge split housing 404. In this example, as the centrifuge split housing 404 rotates counterclockwise around the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 rotates counterclockwise within the centrifuge split housing 404 at a second angular velocity 2ω (for example, approximately twice the first angular velocity).

[0093] The centrifuge assembly 400 may include one or more balancing functional parts, elements, and / or structures positioned around the centrifuge rotation axis 430 of the centrifuge assembly 400. These balancing functional parts can balance the centrifuge assembly 400 axially so as not to substantially impose vibrations on the apheresis system 200 when the centrifuge assembly 400 is rotated around the centrifuge rotation axis 430. In at least one exemplary embodiment, the centrifuge balance weight 418 is mounted on a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B). This centrifuge balance weight 418 may be custom-tuned for the centrifuge assembly 400 and therefore may be selectively mounted to and removed from the centrifuge assembly 400. The tuning of the centrifuge balance weight 418 is calculated and / or experimentally derived, in particular to result in a fully balanced centrifuge assembly 400 when one or more elements of the blood component collection set are mounted.

[0094] Figure 4C is a rear perspective view of the centrifuge assembly 400. Part of the filler 460 is visible through the opening in the upper housing 404B. The blood component collection loop 520 is shown in its initial loop mounting position 520A, in which the first end is interconnected with the filler 460 and the second end is attached and fixed to a fixed loop connection 402 (not shown). It is shown that the blood component collection loop 520 passes through the loop access clearance 436 of the centrifuge split housing 404. When the blood component collection loop 520 is mounted in the loop mounting position 520A, a portion of the blood component collection loop 520 is partially housed, held, and / or supported by the loop storage bracket 426. The loop storage bracket 426 includes one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, and / or assemblies thereof) or bearing surfaces arranged to at least partially support the blood component collection loop 520 as it twists relative to the centrifuge assembly 400. In at least one exemplary embodiment, the blood component collection loop 520 rotates (e.g., in the installed or mounted situation and / or state) around an axis extending along the length of the flexible loop 524, allowing for relative rotational movement of the flexible loop 524 with respect to the loop rotation positioning guide 424. For example, the loop does not “twist up,” but rather rotates or rolls between one or more bearings 417 relative to the loop rotation positioning guide 424 (e.g., the support structure). This rotation or twisting, which does not constrain or twist the flexible loop 524, may be referred to herein as a twist. This twist allows the flexible loop 524 to transmit rotational force to the filler 460 without significantly reducing the inner diameter of the lumen of the flexible loop 524. In some cases, the inner diameter of the lumen of the flexible loop 524 does not decrease at all.

[0095] As described above, when the upper housing 404B is rotated from the unlocked position in the rotational direction shown in Figures 4B-4C to the locked position in the rotational direction, the locking tab 428 of the upper housing 404B engages with the locking slot 432 of the lower housing 404A. In addition to or instead of this, when moved to the locked position in the rotational direction, the loop storage bracket 426 rotates together with the blood component collection loop 520 and the upper housing 404B to a position where it is aligned with the loop rotation positioning guide 424 along the loop engagement position 520B. In at least one exemplary embodiment, as the upper housing 404B and the blood component collection loop 520 rotate to the loop engagement position 520B, the loop capture arm 416 can guide the blood component collection loop 520 to the bearing 417 and / or bearing surface of the loop rotation positioning guide 424. Further details regarding the mounting of the blood component collection loop 520 will be described in relation to Figures 6A-7B.

[0096] Figures 4D to 4F show various schematic cross-sectional views passing through the center of the centrifuge assembly 400 (for example, bisecting the centrifuge assembly 400 by the centrifuge rotation axis 430). As previously stated, the centrifuge assembly 400 includes a lower housing 404A which is rotatably attached to the upper housing 404B by a split housing pivot axis 406 or a hinge. The upper housing 404B is attached to an upper housing adapter 440 which is rotatably connected to an upper housing bushing block 442 which is attached to a pull ring 412. In at least one exemplary embodiment, a bearing 417, bush, or bearing surface may be positioned between the upper housing adapter 440 and the upper housing bushing block 442 to allow the upper housing 404B to rotate along the centrifuge rotation axis 430 from a locked position to an unlocked position and vice versa. The pull ring 412 may be fixed relative to the lower housing 404A in the rotational direction around the centrifuge rotation axis 430. In at least one exemplary embodiment, the upper housing adapter 440 and the upper housing 404B may be formed from a single integrated structure.

[0097] The filler 460 is mounted and fixed to a filler mandrel 434 configured to rotate relative to the upper housing 404B about the centrifuge rotation axis 430. In at least one exemplary embodiment, the filler mandrel 434 may be formed from a portion of the filler 460. In any case, one or more mandrel support bearings 444 are positioned between the filler mandrel 434 and the upper housing adapter 440 to allow the filler 460 to rotate about the centrifuge rotation axis 430 inside the centrifuge split housing 404 and the centrifuge assembly 400. In at least one exemplary embodiment, the filler mandrel 434 may be held in the working position via at least one retaining nut 438. The filler 460 and the filler mandrel 434 can rotate together with respect to the centrifuge split housing 404.

[0098] Figure 4D shows the centrifuge assembly 400 in a closed state (for example, before attaching the blood component collection loop 520). When the upper housing 404B is unlocked relative to the lower housing 404A, the operator pulls the pull ring 412 to rotate the entire upper housing 404B and filler 460 around the split housing pivot axis 406. In at least one exemplary embodiment, the upper housing 404B and filler 460 are partially opened by rotating the components around the split housing pivot axis 406 in the opening direction 446 shown in Figure 4E. As shown in Figure 4E, which shows the centrifuge assembly 400 in a partially opened state, the upper housing 404B and filler 460 are rotated so that their axes are separated from the lower housing pivot axis 430A. In this position, the filler 460 may be made rotatable around the filler pivot axis 430B. When the lower housing 404A and the upper housing 404B are closed, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (to coincide or nearly coincide) to form the centrifugal separator rotation axis 430.

[0099] By continuously rotating the upper housing 404B and filler 460 in the open direction 446 around the Y-axis of the split housing pivot axis 406 (for example, by continuing to pull the pull ring 412), the upper housing 404B and filler 460 can be rotated approximately 180 degrees from the closed position shown in Figure 4D. As shown in Figure 4F, the centrifuge assembly 400 is in the open or mounted position. In this position, the upper housing 404B and filler 460 can be rotated outside the internal space of the apheresis system 200. For example, at least a portion of the upper housing 404B and / or filler 460 is positioned through the open space of the open access panel 224. In this position, a mounting access area 450 is provided with respect to the loop connection area 454 of the filler 460. As can be understood, when the upper housing 404B is in the open position, the interior of the upper housing 404B and filler 460 is easily accessible. In particular, this arrangement allows the operator to provide sufficient space to attach the blood component collection loop 520 to the filler 460 in the loop connection area 454.

[0100] Figure 4G shows, for example, a filler 460 of a centrifuge assembly 400. In at least one exemplary embodiment, the filler 460 is formed from a lightweight material such as plastic, carbon fiber, and / or aluminum. In at least one exemplary embodiment, the filler 460 may be three-dimensionally (3D) printed by a 3D printer. For example, the filler 460 may be manufactured by additive manufacturing techniques or systems such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or additive manufacturing machines. In particular, these additive rapid prototyping manufacturing techniques enable more complex geometric shapes of the filler 460 that may not be possible with the use of conventional machining or manufacturing processes. In at least one exemplary embodiment, the material of the filler 460 is selected based on the desired mass of the filler 460, the desired physical strength of the filler 460 to be manufactured, and / or a material suitable for use in manufacturing.

[0101] The filler 460 includes a loop connection region 454 located substantially at the center of the filler 460. The loop connection region 454 includes one or more key function parts or positive positioning function parts for engaging with a portion of the blood component collection loop 520. As shown in Figure 4G, the loop connection region 454 includes a first positive positioning function part 478 located along a portion of the central axis of the filler 460. The first positive positioning function part 478 may be a keyway, groove, slot, or other function part for engaging with a fitting function part located on the blood component collection loop 520. In at least one exemplary embodiment, the filler 460 has a second positive positioning function part 480 in the loop connection region 454. The positioning function parts 478, 480 prevent rotation of the blood component collection loop 520 in the loop connection region 454 and / or prevent the blood component collection loop 520 from detaching from the loop connection region 454 of the filler 460.

[0102] In at least one exemplary embodiment, the filler 460 includes a separation insertion channel 466 configured to receive and at least partially accommodate a blood component separation bladder of a blood component collection set, more specifically, a blood component collection loop 520. The separation insertion channel 466 is configured as a groove, slot, extending substantially spirally outward from the center of the filler 460. In at least one exemplary embodiment, the separation insertion channel 466 follows a substantially spiral path including a first spiral path portion extending outward along the longitudinal direction of the circumference of the separation insertion channel 466 to a substantially constant radius from the center of the filler 460 (for example, relative to the center of the filler 460). In any case, the path is referred to herein as a spiral path or substantially spiral path. The separation insertion channel 466 begins at a channel inlet 468 near the center of the filler body 464 and ends at a channel end 472 near the point furthest from the center of the filler body 464. As shown in Figures 4G to 4I, the separation insertion channel 466 extends along a substantially helical path 490 that extends from a point near the filler rotation axis 430B to the channel end 472. The substantially helical path 490 includes a channel path curve 476 at a point close to or adjacent to the channel end 472. This channel path curve 476 increases the distance between the center of the filler body 464 and the separation insertion channel 466, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the separation insertion channel 466. In at least one exemplary embodiment, this channel path curve 476 corresponds to a critical inlet / outlet port at the maximum radial position in the blood component separation bladder 536, which is at least partially inserted or positioned 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 projections 482 positioned on or near part of the filler body 464. These filler balancing projections 482 can result in a filler 460 that is axially balanced (e.g., balanced around the filler rotation axis 430B), especially when the separation insertion channel 466 contains a blood component separation bladder and fluid (e.g., blood, blood components).

[0103] Figure 4I shows a substantially helical receiving channel or separation / insertion channel 466 in the filler 460. This schematic plan view shows a first distance R1 of the separation / insertion channel 466 from the center of the filler body 464 at a first point along the substantially helical path 490 (e.g., near the filler rotation axis 430B), and a second distance R2 of the portion of the separation / insertion channel 466 past the point near the channel path curve 476 from the center of the filler body 464. As shown in Figure 4I, the second distance R2 is further from the center of the filler body 464 than the first distance R1. This increment in distance allows for a higher centripetal or centrifugal force to be applied to the channel at the channel end 472 or a point near it than at any other point along the substantially helical path 490. In at least one exemplary embodiment, the end of the blood component separation bladder substantially coincides with the channel end 472, thereby resulting in the greatest blood separation force at the end of the bladder.

[0104] Figures 4J to 4L show various elevational and cross-sectional views of the filler 460, more specifically, the separation insertion channel 466 and filler insertion chamber 492 located inside the filler body 464. In at least one exemplary embodiment, the separation insertion channel 466 has a cross-section or shape substantially following a substantially helical path 490 within the filler body 464. The separation insertion channel 466 includes an insertion groove configured to receive a substantially flat or unfilled blood component separation bladder. The blood component separation bladder is inserted into the separation insertion channel 466 and into the filler insertion chamber 492 formed within the filler body 464 along the substantially helical path 490. The filler insertion chamber 492 is defined by one or more side walls 494, 496 that form a cavity following the substantially helical path 490. As shown in Figure 4K, the filler insertion chamber 492 includes an inner chamber wall 494 at a given distance from at least one outer chamber wall 496. The filler insertion chamber 492 may be formed on the filler 460 by 3D printing the filler 460 and / or by some one or more other metal or plastic molding processes (e.g., casting, molding, and / or shaping). In at least one exemplary embodiment, the filler insertion chamber 492 includes one or more insertion guide functional portions 498. These insertion guide functional portions 498 are configured to guide, position, and / or seat a blood component separation bladder of the filler 460 inside the filler insertion chamber 492. The insertion guide functional portion 498 is shown as a chamfered retract functional portion of the filler insertion chamber 492, but may include one or more radii, chamfers, bevels, tapers, draft angles, receptacles, grooves, and / or other molded portions configured to guide and / or direct a portion of the inserted blood component separation bladder.

[0105] Figure 4L shows different states of a fluid separation bladder (e.g., a blood component separation bladder) positioned within the separation insertion channel 466 and filler insertion chamber 492 of the filler 460. As previously described, the blood component separation bladder is inserted into the separation insertion channel 466 in a substantially flat, i.e., unfilled state S1. In the substantially flat state S1, the blood component separation bladder is sized to enter the upper opening of the separation insertion channel 466 and remain in the filler insertion chamber 492 in a pre-filled state. As the filler 460 rotates and begins to separate blood components from the blood supplied by the donor 102, the blood component separation bladder expands from the substantially flat first state S1 to an expanded, i.e., filled state S2. In at least one exemplary embodiment, the blood component separation bladder may expand with blood and / or blood components until the walls of the blood component separation bladder contact the walls 494, 496 of the filler insertion chamber 492. In at least one exemplary embodiment, the shape of the filler insertion chamber 492 is designed to optimize the amount of fluid that can be collected and / or separated within the filler insertion chamber 492 (for example, maximizing the amount of fluid while minimizing the amount of material for the filler 460).

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

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

[0108] The blood component collection loop 520 includes a flexible loop 524 positioned between the system fixed loop connector 528 and the filler loop connector 532. The flexible loop 524 may be configured as a hollow flexible tube configured to receive and / or accommodate at least a portion of the loop inlet tube 108B and the loop outlet tube 112. In at least one embodiment, the flexible loop 524 may be formed from a highly flexible thermoplastic elastomer capable of transmitting twist from one end of the flexible loop 524 to the other. These types of elastomers can provide the flexibility of rubber while maintaining the strength and torque properties of plastic. Examples of thermoplastic elastomers include, but are not limited to, copolyester, DuPont® Hytrel® thermoplastic elastomers, Eastman Neostar® elastomers, Celanese Riteflex® elastomers, TOYOBO PELPRENE® elastomers, and / or other manufacturers' elastomers that provide high flexibility and strength properties.

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

[0110] Details of the blood component collection loop 520 are described in relation to the elevation view in Figure 5B. The blood component collection loop 520 includes a flexible loop 524 configured as a tube that includes a first path for a loop inlet tube 108B and a second path for a loop outlet tube 112. In at least one embodiment, the loop inlet tube 108B passes through the flexible loop 524 and interconnects with the first collection flow chamber 544 at the bladder loop end 540A via a filler loop connector 532. In addition to or instead of this, the loop outlet tube 112 may pass through the flexible loop 524 and interconnect with the second collection flow chamber 552 at the bladder loop end 540A via a filler loop connector 532. The first path is separate from the second path. This configuration allows blood to enter the flexible loop 524 and the blood component separation bladder 536 via the first collection flow chamber 544 and separate into one or more blood components. Subsequently, the blood components are transported along the second collection flow chamber 552 to the loop outlet tube 112 in the flexible loop 524.

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

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

[0113] In at least one embodiment, the blood component collection loop 520 may include several positive positioning or keying functional parts 530A, 530B configured to reliably (positively) position multiple locations of the blood component collection loop 520 relative to the apheresis system 200 and / or filler 460. For example, the blood component collection loop 520 includes a first connector positioning functional part 530A on the system fixed loop connector 528 and a second connector positioning functional part 530B on the filler loop connector 532. The functional parts 530A, 530B may be configured as keys, tabs, and / or other protrusions made of material extending from the connectors 528, 532. In at least one exemplary embodiment, the second connector positioning function portion 530B may include a function portion that interconnects with or engages with the first positive positioning function portion 478 and / or the second positive positioning function portion 480 of the loop connection region 454 of the filler 460. Similar, if not identical, positive positioning function portions may be associated with or included in the fixed loop connection portion 402 of the apheresis system 200.

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

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

[0116] Figures 5E to 5H show various perspective views of the blood component collection loop 520 in a bent state (e.g., Figures 5E to 5F), as well as figures showing the bent blood component separation bladder 536 of the blood component collection loop 520 inserted into the filler 460 (e.g., Figures 5G to 5H). The various components of the blood component collection loop 520 may be flexible and / or can be shaped or molded by the application of force. In at least one exemplary embodiment, this flexibility may be elastic, such that the components do not permanently deform even if the various parts of the blood component collection loop 520 are shaped. Figure 5E shows the blood component collection loop 520 in a bent state. For example, the flexible loop 524 is shown elastically bent along its length, and the blood component separation bladder 536 is shown following many bent or curved portions along its length. The flexible loop 524, while its components are bent, transports fluid supplied through the loop inlet tube 108B to the first collection flow chamber 544 of the blood component separation bladder 536, and vice versa. In addition to or instead of this, the flexible loop 524 may also transport fluid from the second collection flow chamber 552 of the blood component separation bladder 536 to the loop outlet tube 112, and vice versa, while its components are bent.

[0117] In at least one exemplary embodiment, the blood component collection loop 520 may be pre-formed to fit into the separation insertion channel 466 of the filler 460, for example, as shown in Figure 5F. This pre-forming may include bending the blood component separation bladder 536 of the blood component collection loop 520 to conform to the substantially helical path 490 of the separation insertion channel 466. Once pre-formed, the functional portion of the blood component collection loop 520 may be aligned with one or more functional portions of the filler 460, as shown in Figure 5G. In at least one exemplary embodiment, the filler loop connector 532 of the blood component collection loop 520 is aligned with the loop connection region 454 of the filler 460 such that a second connector positioning functional portion 530B is aligned to engage with a first positive positioning functional portion 478. In addition to or instead of this, the blood component separation bladder 536 may be shaped or trimmed (e.g., by hand) to fit the substantially helical path 490 of the separation insertion channel 466 in the filler 460. In some cases, this shaping or trimming may include aligning the bladder free end 540B of the blood component separation bladder 536 with the channel end 472 of the separation insertion channel 466 in the filler 460. As the components are roughly aligned with one another, the blood component collection loop 520 may be moved toward the separation insertion channel 466 and the loop connection region 454 (as shown in Figure 5G).

[0118] In at least one exemplary embodiment, as the filler loop connector 532 is moved into the loop connection region 454 of the filler 460, the first positive positioning function portion 478 interconnects with and / or holds the second connector positioning function portion 530B of the filler loop connector 532 of the blood component collection loop 520. This interconnection prevents the filler loop connector 532 from rotating relative to the filler 460. In some cases, this interconnection holds the filler loop connector 532 of the blood component collection loop 520 within the loop connection region 454 of the filler 460. Figure 5H shows the blood component collection loop 520 fitted into the filler 460 according to at least one exemplary embodiment of the present disclosure.

[0119] Figures 6A to 6C show the centrifuge assembly 400 in various loop mounting configurations according to the embodiments of this disclosure. The centrifuge assembly 400 shown in Figures 6A to 6C corresponds to the centrifuge assembly 400 described above, particularly in relation to Figures 4D to 4F. Specifically, Figure 6A shows a schematic cross-sectional view of the first loop mounting configuration, Figure 6B shows a schematic cross-sectional view of the second loop mounting configuration, and Figure 6C shows a schematic cross-sectional view of the second loop mounting configuration for the centrifuge assembly 400.

[0120] In Figure 6A, the centrifuge assembly 400 is shown in the open loop mounting position, in which the upper housing 404B is rotated 180 degrees from the closed position, i.e., the operating position. This open position corresponds to the position of the centrifuge assembly 400 shown in Figure 4F. However, in Figure 6A, the blood component collection loop 520 is inserted into the filler 460, and the filler loop connector 532 is interconnected with the loop connection region 454 of the filler body 464. The other end of the blood component collection loop 520 is connected to the fixed loop connection section 402 via the system fixed loop connector 528. In this first loop mounting state, the flexible loop 524 is fixed to the fixed loop connection section 402 so as not to rotate, but rotates together with the filler 460 in the loop connection region 454.

[0121] In Figure 6B, the centrifuge assembly 400 is shown in a partially closed position, in which the upper housing 404B is moving from the open position to the closed position, i.e., the operating position. As the upper housing 404B rotates, the flexible loop 524 can move to a stationary position relative to the centrifuge assembly 400. The flexible loop 524 is fixed in the rotational direction at the fixed loop connection 402, but the filler 460 can rotate freely around the filler rotation axis 430B (limited, for example, only by the flexible loop 524 which is fixed in the rotational direction).

[0122] In Figure 6C, the centrifuge assembly 400 is shown in the closed position, i.e., the operating position, in which the upper housing 404B can be locked to the lower housing 404A (so that the lower housing 404A and the upper housing 404B can rotate together around the centrifuge rotation axis 430). In this position, the flexible loop 524 extends from the loop connection area 454 of the filler 460 through the loop access clearance 436 of the centrifuge split housing 404 to the fixed loop connection 402. In at least one exemplary embodiment, the flexible loop 524 can move freely within the loop access clearance 436, with or without contact with one or more portions of the centrifuge split housing 404. In this position, as the centrifuge assembly 400 rotates around the centrifuge rotation axis 430, the flexible loop 524, which is fixed in the rotational direction at the fixed loop connection 402, can twist along the length of the flexible loop 524, thereby causing the filler 460 to rotate within the centrifuge assembly 400 (for example, along the centrifuge rotation axis 430). As previously mentioned, the rotation of the filler 460 relative to the centrifuge assembly 400 may be in a 2:1 ratio. For example, as the centrifuge assembly 400 rotates one full turn, the flexible loop 524, which is fixed in the rotational direction (for example, fixed at the fixed loop connection 402), twists in the loop connection region 454 (for example, attempting to unwind from the twist caused by the rotation of the centrifuge assembly 400), thereby causing the filler 460 to rotate in the same rotational direction as the centrifuge assembly 400, but approximately two full turns. This rotation of the filler 460 by the twist along the length of the flexible loop 524 does not require engagement between the centrifuge assembly 400 and the filler 460.

[0123] Figures 7A and 7B show schematic plan views of a centrifuge assembly 400 that automatically mounts the loop to the centrifugation operating position (e.g., blood separation). The centrifuge assembly 400 shown in Figures 7A and 7B may correspond to the centrifuge assembly 400 described and / or explained above in relation to Figures 4A to 4F and Figures 6A to 6C. Once the blood component collection loop 520 is mounted within the centrifuge assembly 400 as shown in Figure 6C, the flexible loop 524 is automatically mounted to the loop engagement position 520B as shown in Figures 7A and 7B.

[0124] In at least one exemplary embodiment, when the upper housing 404B is locked into the lower housing 404A, the flexible loop 524 extends from the loop connection area 454 of the filler 460 to the fixed loop connection 402 of the apheresis system 200. The flexible loop 524 may be rotatably fixed to the fixed loop connection 402 by the system fixed loop connector 528, but the flexible loop 524 passing through the loop access clearance 436 of the centrifuge split housing 404 may not be initially held, or at least partially captured, by the loop rotation positioning guide 424 and / or other functional parts of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop rotation positioning guide 424 or loop arm corresponds to the uncaptured loop state 700A. In other words, the flexible loop 524 may be positioned at some angle α with respect to the loop rotation positioning guide 424, the loop positioning stopper plate 704, and / or one or more loop torsion support bearings 708, or a set of bearings. In at least one exemplary embodiment, the loop torsion support bearing 708 may correspond to the bearing 417 described in conjunction with Figures 4B-4C. The loop storage area, or channel, may be formed by one or more loop torsion support bearings 708 positioned along the length of the loop positioning stopper plate 704 and / or the upper housing 404B. In at least one exemplary embodiment, this arrangement may be designed to allow for ease of access and / or mounting in the loop mounting described in conjunction with Figures 6A-6C.

[0125] As the centrifuge assembly 400 is rotated in the loop-filler rotation direction 712 around the centrifuge rotation axis 430, the flexible loop 524 can move from an uncaptured loop state 700A to a captured loop state 700B as shown in Figure 7B. This rotation may be performed by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the loop-filler rotation direction 712, and / or by a rotor motor assembly 414 rotating the centrifuge assembly 400 around the centrifuge rotation axis 430. In at least one exemplary embodiment, as the flexible loop 524 rotates in the loop-filler rotation direction 712, the outer portion of the flexible loop 524 comes into contact with the loop positioning stopper plate 704 or another rotation stopper surface of the loop rotation positioning guide 424.

[0126] With the flexible loop 524 held or at least partially housed within the loop rotation positioning guide 424, a portion of the flexible loop 524 can move within one or more of the loop torsion support bearings 708. As previously stated, the flexible loop 524 is rotationally fixed to the fixed loop connection 402 via the first connector positioning functional portion 530A of the system fixed loop connector 528 associated with the blood component collection loop 520. This rotationally fixed connection prevents the flexible loop 524 from rotating relative to the apheresis system 200 at the fixed loop connection 402. The other end of the flexible loop 524 is interconnected at the loop connection region 454 of the filler 460 so that this end can move together with the filler 460 and / or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the loop filler rotation direction 712, the force from the flexible loop 524 to avoid unraveling or entanglement causes the filler 460 and the end of the flexible loop 524 attached to the filler to rotate.

[0127] In any case, once the fluid separation method described herein is completed, the rotation of the centrifuge assembly 400 is stopped, and the centrifuge split housing 404 is opened to remove the disposable elements of the blood component collection set 500 from the centrifuge assembly 400. In some cases, the flexible loop 524 may be moved from the captured loop state 700B shown in Figure 7B to the uncaptured loop state 700A shown in Figure 7A by rotating the centrifuge assembly 400 and / or filler 460 in the opposite direction to the loop filler rotation direction 712.

[0128] An exemplary functional diagram of the apheresis system 200 is shown in Figure 8. This explanation describes the operation of the system 200 for extracting plasma or other blood components from the whole blood of donor 102 during an apheresis procedure or process, and therefore shows the components in the functional diagram that have already been described in Figures 1 to 7B.

[0129] System 200 may include an anticoagulant (AC) pump 216. The AC pump 216 delivers fluid from the AC bag 114 into the AC tube 110. The AC pump 216, AC tube 110, and / or AC bag 114 may be those described above. The AC tube 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tube 110. The AC ADS 804 may be of the same type and / or function as the sensors 284 and / or 312 already described. The AC tube 110 is fluidically associated with the donor supply tube 104 and the cassette inlet tube 108A by intersecting them at a tube connector 106. The tube connector 106 may be any type of connection between tubes 110, 104, and / or tube 108A, as already described.

[0130] The donor supply tube 104 extends from the donor 102, in which case the donor 102 may be punctured with a lumen needle or other device, thereby allowing whole blood to flow from the donor 102 into the apheresis system 200 and blood components to flow back into the donor 102. Tube 108A extends to the soft cassette 340. Furthermore, a donor air detection sensor 312 can be placed on or inside tube 108A to detect the presence of fluid and / or air in tube 108A.

[0131] As already described, the soft cassette 340 may include a "Y" connector or section or branch that can function as a "Y" connector or section or branch, and / or may be substantially adjacent to the "Y" connector or section or branch, which separates tube 108A into a first bypass branch 358A and a first tube section 368A (the "Y" section is indicated by reference letter 360A). The two tube sections 358, 368 are reconnected at a second cassette port 360B that may also include a second "Y" connector or section that can function as a second "Y" connector or section, and / or may be substantially adjacent to the second "Y" connector or section (the second "Y" section is indicated by reference letter 360B). Tube 358 is divided into two by the fluid sensor 316, which divides tube 358 into a first bypass branch section 358A and a second bypass branch section 358B. Similarly, tube 368 is divided into two by the drip chamber 354, which divides tube 368 into a first tube section 368A and a second tube section 368B.

[0132] The first tube section 368A may include a first fluid control valve 320A. The second tube section 368B may include a second fluid control valve 320B. The first bypass branch 358A may include a draw-in fluid control valve 320C. Thus, depending on the configuration of the system 200 and the operation of the system 200, various sections of the tubes 368A, 358A, 358B, and 368B can be isolated by valves 320A, 320B, and / or valve 320C.

[0133] The drip chamber 354 is located between the first tube section 368A and the second tube section 368B. The drip chamber 354 can collect a predetermined amount of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) depending on the operation of the system 200, as will be described later. The fluid sensor 316 is located between the first bypass branch 358A and the second bypass branch 358B, as already described.

[0134] The loop inlet tube 108B is connected to the second cassette port 360B, connecting the soft cassette 340 to the flexible loop 524. The loop inlet tube 108B may also include a sensor 808 located on or inside the tube 108B, which is positioned with the tube 108B before connecting to the system fixed loop connector 528 of the flexible loop 524. The pressure sensor (CPS) 808 may detect one or more of the pressure, presence or absence of fluid or air in the tube 108B, and / or, optionally, other properties of the fluid. Furthermore, a draw-in pump 208 can pump fluid through the tube 108B away from or towards the soft cassette 340.

[0135] Two or more different tubes can be connected to the flexible loop 524 via the system fixed loop connector 528, and two or more different tubes can supply fluid to or receive fluid from the blood component separation bladder 536. The loop outlet tube 112 exits the flexible loop 524 through the system fixed loop connector 528. This loop outlet tube 112 may also include other line sensors 812 placed on or inside the loop outlet tube to detect fluid, air, intracellular concentration, color, and / or color changes in the fluid coming from the flexible loop 524. The line sensors 812 may be of the same or similar type and / or function as sensors 804, 312, 320, 808 and / or sensor 284 already described. A second CPS sensor 816 or fluid sensor may be placed inside or on line 112. Sensor 816 may detect, but is not limited to, the presence or absence of fluid in tube 112, its pressure, and / or one or more other characteristics of the fluid in tube 112. Sensor 816 may be of the same or similar type and / or function as sensors 804, 312, 320, 808, 812, and / or sensor 284 already described.

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

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

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

[0139] Each node may function to control a different part of the apheresis system 200. For example, the control system 900 may include a cassette node 904 and a centrifuge node 908 that can control or communicate with components of the blood component collection set 500 (and associated hardware or mechanical components that interface with the soft cassette assembly 300) and the centrifuge assembly 400 (and associated hardware or mechanical components associated with the centrifuge assembly). The cassette node 904 and the centrifuge node 908 may communicate wirelessly or via some other electrical or data connection. In at least one exemplary embodiment, the separate nodes 904, 908 may be two parts of a single node 902. Thus, each node 904, 908 may have the same physical hardware operating to control different functions. An example of a cassette node 904 can be described in relation to Figure 10, and a centrifuge node 908 can be described in relation to Figure 11.

[0140] Each of nodes 904 and 908 may communicate with one or more sensors 916, 920, and / or sensor 924. There may be more or fewer sensors than those shown in Figure 9, as indicated by the ellipsis 928. Each node 904 and 908 may communicate directly with each sensor 916-924, or it may communicate with several sensors 916-924 via bus 912. Bus 912 may communicate by any type of communication protocol, such as Universal Serial Bus (USB), Universal Asynchronous Transceiver (UART), or other types of bus systems or parallel communication connections. Thus, bus 912 is shown as an optional but possible communication platform for communicating with various sensors 916-924. Sensors 916-924 may be any type of sensor capable of communicating information about light, fluid, presence of air, color, and / or pressure. Some of the sensors 916-924 may include sensors 312, 316, 804, 808, 812, 816 and / or sensor 284. The functions of these sensors 912-924 may be as described later.

[0141] Nodes 904 and 908 may communicate with one or more pump drives, pump motors 936, 940, and 944, simply referred to as "pumps." There may be more or fewer pumps than those shown in Figure 9, as indicated by the abbreviation 948. Nodes 904 and 908 can communicate with pumps 936-944 via direct wired or wireless communication or via bus 932. Bus 932 may be a Control Area Network (CAN) bus, USB, or other type of bus architecture for communicating with pumps 936-944. Pumps 936-944 may include pumps 216, 208, and / or pump 212, as already described. The functions of pumps 936-944 are described herein.

[0142] Figure 10 shows an exemplary cassette node 904. The cassette node 904 may include a controller 1004, memory 1008, valve controller 1020, and / or one or more communication interfaces for a CAN bus 1016, UART 1012, or other types of buses. The cassette node 904 may also include other hardware, firmware, and / or software, which are not shown for clarity.

[0143] The controller 1004 may be any type of microcontroller, microprocessor, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc. An example of the controller 1004 may be the NK10DN512VOK10 microcontroller, manufactured and sold by N9P USA, Incorporated, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are also conceivable. 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, and pumps 936-944. Furthermore, the controller 1004 can communicate with various sensors 916-924 or other devices to receive or send information about the functions of the apheresis system 200.

[0144] Other examples of processors or microcontrollers 1004 as described herein include Qualcomm® Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTE Integration and 64-bit computing, Apple® A7 processor with 64-bit architecture, Apple® M7 motion coprocessor, Samsung® Exynos® series, Intel® Core® processor family, Intel® Xeon® processor family, Intel® Atom® processor family, Intel Itanium® processor family, Intel® Core® i5-4670K and i7-4770K 22nm Haswell, and Intel® Core® i5-3570K 22nm The computer may include, but is not limited to, at least one of the following: IvyBridge, AMD® FX® processor family, AMD® FX-4300, FX-6300, and FX-8350 32nm Vishera, AMD® Kaveri processor, ARM® Cortex®-M processor, ARM® Cortex-A and ARM926EJ-S® processor, or other industrial equivalent processors, and may perform computer functions using any known or future-developed standard instruction sets, libraries, and / or architectures.

[0145] Memory 1008 may be random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disk read-only memory (CD-ROM), optical memory, magnetic memory, any suitable combination thereof, or any other type of memory including other types of memory devices or memory units that store and provide instructions for programming and controlling the controller 1004. Memory 1008 may also provide all types of software or firmware for programming the functions of the controller 1004, as described later.

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

[0147] The controller 1004 can also be connected to buses 912, 932 (e.g., UART bus and / or CAN bus) or other buses via transceivers 1012, 1016 located outside or integrated with the controller 1004. The UART transceiver 1012 may communicate with one or more of the sensors 916-924 or other devices. Similarly, the CAN bus transceiver 1016 can communicate with one or more of the pump controllers 936-944 or other devices. The UART transceiver 1012 and bus and the CAN bus transceiver 1016 and bus are well known in the art and do not need to be further described herein.

[0148] Figure 11 shows an exemplary centrifuge node 908. The centrifuge node 908 may include the same or similar types of components as the cassette node 904. For example, the centrifuge node 908 may include a controller 1104 and / or a UART transceiver 1112. Similar to the controller 1004, the controller 1104 may be any type of processor or microcontroller, for example, the NK10DN512VOK10 microcontroller unit with a 32-bit architecture provided by N9P USA, Incorporated as already mentioned, or other controllers, processors (e.g., the devices already mentioned).

[0149] Controller 1104 can communicate with sensors 916-924 via UART transceiver 1112 or directly via another bus or system. Controller 1104 can also communicate with brake controller 1124, which can brake, decelerate, and stop the centrifuge 400. Similarly, controller 1104 can communicate with motor transceiver 1116. Motor transceiver 1116 communicates with a motor power system or motor controller that functions to spin up or rotate the centrifuge 400, or to control the speed setting or other functions of the centrifuge 400.

[0150] 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 arm during the apheresis process. Furthermore, as already described, the controller 1104 can communicate with and / or control the strobe 1112, which is a light of any kind that flashes periodically in sync with the rotational speed of the motor, so that an operator of the apheresis system 200 can observe the operation of the filler 460. Thus, the controller 1104 communicates with the strobe 1112 to change the frequency of the flashing of the light of the strobe 1112, the intensity of the light of the strobe 1112, etc.

[0151] Figure 12 shows an exemplary method 1200 used to perform apheresis of a blood component (e.g., plasma) using a system 200, according to at least one exemplary embodiment of the present disclosure. Method 1200 may be described in relation to Figures 17A to 17T. Thus, Method 1200 will be described with respect to or with reference to these figures. Figure 12 shows a general sequence of steps in Method 1200. Generally, Method 1200 begins with initiation step 1204 and ends with step 1220. Method 1200 may include more or fewer steps, or the order of steps may be different from the order shown in Figure 12. Method 1200 may be performed at least in part as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other devices. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, Method 1200 can be at least partially carried out by a set of components, circuits, and / or gates fabricated 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, Method 1200 will be described in relation to, for example, systems, apparatus, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, and / or apheresis systems, as described in relation to Figures 1 to 11.

[0152] Generally, Method 1200 can be divided into three stages, in which case each stage includes a series of steps or processes. Each of the three stages is shown in Figure 12 and will be explained with reference to Figures 13 to 16 which illustrate the steps or processes. Method 1200 includes a system preparation stage in step 1208. In this stage 1208, the operator may prepare the system 200 for apheresis, which may include the steps of inserting a needle into the donor 102, performing other actions to prepare for blood collection, and inserting the blood component collection set 500 into the system. Examples of steps that may be included in the system preparation stage 1208 will be explained with reference to Figure 13.

[0153] Method 1200 proceeds to step 1212, which involves entering a plasma ingestion phase. The plasma ingestion phase 1212 is described with reference to Figure 14. The plasma ingestion phase 1212 may include drawing in 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 has been collected). The initiation of a return cycle may be triggered based on the presence of one or more blood components (e.g., platelets and / or red blood cells) at some predetermined location within the apheresis system.

[0154] The final stage of Method 1200 is the disposable item removal stage in step 1216. The disposable item removal stage 1216 is described with reference to Figure 15. The disposable item removal stage 1216 may include the completion of the apheresis process, the removal of the needle from the donor 102, the removal of the blood component collection set 500, and the completion of the procedure. Hereinafter, each of the three stages 1208-1216 and the steps or processes associated with these stages will be described.

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

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

[0157] As shown in Figure 2D, the saline / plasma tube y-connector 280 is attached to the plasma / saline valve control system 228. This allows valves 286 and 288 to control the fluid flow from and to the plasma collection bottle 122 and / or saline bag 118. As shown in Figures 1 to 2B, the AC bag 114 is attached to the anticoagulant support 232A, the plasma collection bottle 122 is placed in the plasma collection cradle 232C, and the saline bag 118 is attached to the saline support 232B. With the blood component collection set 500 attached to the apheresis system 200, the apheresis system 200 will be as shown in Figures 17A and 17B. The state of the various components of the apheresis system 200 during this step is as shown below.

[0158] [Table 1]

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

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

[0161] [Table 2]

[0162] In step 1316, saline solution 1712 is primed. Priming of saline solution 1712 includes the cassette microcontroller 1004 instructing the opening of the saline flow control valve 288, as shown in Figure 17D. The cassette microcontroller 1004 receives instructions or programs for a user interface to initiate the apheresis process, which begins with priming the saline solution 1712. This causes the saline solution 1712 to move from the saline bag 118, through the saline flow control valve 288, to the plasma air detection sensor 284. The cassette microcontroller 1004 instructs the return pump 212 to rotate counterclockwise to cause a volumetric flow of saline solution 1712 from the saline bag 118, through the saline tube 116 and the saline-plasma tube Y-connector 280 attached to the plasma-saline valve control system 228, to the plasma air detection sensor 284. When the plasma air detection sensor 284 detects either the presence or absence of liquid in the loop outlet tube 112, a signal is sent to the cassette microcontroller 1004. The cassette microcontroller 1004 instructs the return pump 212 to stop rotating and the saline flow control valve 288 to close. This prevents saline 1712 from flowing further into the loop outlet tube 112 beyond the plasma air detection sensor 284. At this point in the process, the apheresis system is as shown in Figure 17E. The states of the various components of the apheresis system 200 during this step are as follows.

[0163] [Table 3]

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

[0165] Furthermore, the volume and rate of transfer within the apheresis system 200 are referred to or described in the tables included herein. However, these volumes and rates depend on the size of the tubing, the size of the bag used, the desired amount of blood component to be collected (e.g., 880 mL of plasma), and other considerations. State or national laws and other directives may specify the volumes and rates used in the apheresis system 200, or these volumes and rates may be predetermined based on the instructions of a medical professional or based on the characteristics of the donor 102. Thus, the volumes and rates are merely illustrative, and those skilled in the art will understand which volumes and rates should be used for the following steps and processes.

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

[0167] [Table 4]

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

[0169] To determine when to stop the AC pump 216, the cassette microcontroller 1004 receives signals from the fluid sensor 316 and / or the donor air detection sensor 312 indicating that fluid is present in or passing through sensors 312, 316. When the fluid sensor 316 sends a notification to the cassette microcontroller 1004 that AC1702 has reached sensor 316, the cassette microcontroller 1004 continues to instruct the AC pump 216 for a predetermined period until a known amount of AC1702 is delivered through the second cassette port 360B to a portion of the loop inlet tube 108B. Thus, priming of AC1702 brings the apheresis system 200 to the state shown in Figure 17G. The states of the various components of the apheresis system 200 during this step are as shown below.

[0170] [Table 5]

[0171] In at least one exemplary embodiment, the direction of the AC pump 216 may be reversed, as shown in Figure 17G. At least a portion of the anticoagulant 1702 may be returned to the AC bag 114 and / or to a portion of the cassette inlet tube 108A and / or the anticoagulant tube 110. In at least one exemplary embodiment, the cassette microcontroller 1004 can instruct the draw-in fluid control valve 320C to close, thereby holding the AC in the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The donor air detection sensor 312 can determine when to stop the AC 1702 from passing through the sensor 312 and send a signal to the cassette microcontroller 1004. In this case as before, the cassette microcontroller 1004 can continue to instruct the AC pump 216 for a predetermined period of time until a known amount of AC 1702 has been returned through the cassette inlet tube 108A. Therefore, AC1702 remains in the apheresis system 200 in the state shown in Figure 17G. The amount of anticoagulant remaining in the cassette inlet tube 108A, tube connector 106, and / or anticoagulant tube 110 may be determined by the cassette microcontroller 1004 by a predetermined time after the anticoagulant 1702 has passed the donor air detection sensor 312. This process leaves some anticoagulant in the cassette inlet tube 108A, but by reducing the amount of AC used, the problem of mixing an excess amount of AC with the incoming whole blood is avoided. In step 1212 (Figure 12), the apheresis system 200 is ready to withdraw whole blood and is ready to withdraw whole blood at any time. The state of the various components of the apheresis system 200 during this step is as shown below.

[0172] [Table 6]

[0173] Figure 14 shows an exemplary method 1400 representing the plasma ingestion stage 1212 according to an embodiment of the present disclosure. Method 1400 begins with a start step 1404 and ends with a step 1440. Method 1400 may include more or fewer steps, or the order of steps may be different from the order shown in Figure 14. Method 1400 may be at least partially executed as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other devices. The set of instructions may be encoded or stored in a computer-readable medium. In at least one exemplary embodiment, Method 1400 may be at least partially executed by a set of components, circuits, and / or gates fabricated in a hardware device such as a SOC, ASIC, and / or FPGA. Hereafter, Method 1400 will be described in relation to, for example, systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, and / or methods, as described in relation to Figures 1 to 13.

[0174] In step 1408, the needle is inserted into the donor 102. A phlebotomist, apheresis technician, or other medical professional attaches a needle with a lumen to the tubing attachment 504 and inserts the needle into the donor 102's blood vessel (e.g., a vein). Thus, the apheresis system 200 is fluidly connected to the donor 102 and ready to draw whole blood at any time. In this way, the apheresis system 200 begins the plasma draw-in phase 1212 with the donor 102 ready to supply whole blood at any time, as shown in Figure 17H. The states of the various components of the apheresis system 200 during this step are as follows.

[0175] [Table 7]

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

[0177] [Table 8]

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

[0179] [Table 9]

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

[0181] In step 1420, the cassette microcontroller 1004 initiates the initial draw-in of plasma 1704 or other blood components from the whole blood 1706. The cassette microcontroller 1004 continues to operate the AC pump 216 to supply the anticoagulant 1702 to the cassette inlet tube 108A and mix it with the whole blood 1706 from the donor 102. Furthermore, the cassette microcontroller 1004 continues to operate the draw-in pump 208 to move the whole blood 1706 into the blood component separation bladder 536 and separate the plasma 1704 from the whole blood 1706. To perform the separation of plasma 1704, the cassette microcontroller 1004 informs the centrifuge microcontroller 1008 that the draw-in step has begun. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to begin rotating or spinning at a higher rotational speed (RPM) (e.g., approximately 5000 RPM) to begin separating red blood cells 1708 from plasma 1704, as shown in Figure 17K. The draw pump 208 continues to push the plasma 1704 into the loop outlet tube 112 via the flexible loop 524 and the system fixed loop connector 528. The draw process 1420 continues until, at some point, the platelets 1710 separated from the whole blood 1706 reach the line sensor 812, as shown in Figure 17L. The line sensor 812 informs the cassette microcontroller 1004 that the entire volume of plasma 1704 from the whole blood 1706 sent into the blood component separation bladder 536 has been extracted. The cassette microcontroller 1004 proceeds to step 1424. The state of the various components of the apheresis system 200 is as follows during this step.

[0182] [Table 10]

[0183] Additionally or alternatively, the radial position of the interface 1709 between plasma 1704 and red blood cells (RBCs) 1708 within the blood component separation bladder 536 and / or the RBC interface 1709 is determined as the RBC interface 1709 rises in the centrifugal field during the separation of plasma 1704. The radial position of the interface 1709 may also be determined by a fluid for monitoring the inlet pressure of the centrifuge assembly 400. For example, a sensor 808 located on or within tube 108B determines the inlet pressure to the centrifuge assembly 400. Alternatively, another sensor located on or within the flow path to the centrifuge assembly 400 may determine the inlet pressure. As the RBC interface 1709 rises within the blood component separation bladder 536, the plasma 1704 is moved by the red blood cells 1708 in the RBC layer (RBC bed). As the radial position of the RBC interface 1709 gradually rises (delta R), the back pressure affecting the inlet pressure to the centrifuge assembly 400 (e.g., back pressure on sensor 808 or other sensors) increases according to the product of delta R, the mean value (G) of the centrifugal force field between the radial position of the channel inlet and the radial position of the RBC interface 1709, and the RBC layer density minus the plasma density. In short, the back pressure affecting the inlet pressure to the centrifuge assembly increases by the following equation: delta R × (RBC layer density - plasma density) × G. For example, in at least one exemplary embodiment, the total change in back pressure from the start of RBC layer formation until the RBC exits at the center of rotation is approximately 220 mmHg when the centrifuge is rotated at approximately 5000 RPM and RBC layer formation begins at a radius of approximately 67 mm.

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

[0185] Alternatively, if it is determined that the RBC interface 1709 is at its radially innermost position, the cassette microcontroller 1004 determines in step 1426 whether blood collection is complete. For example, the radially innermost position is adjacent to the filler loop connector 532. Completion of blood collection means that the entire required or desired amount of plasma 1704 has been drawn into the plasma collection bottle 122. In at least one exemplary embodiment, the cassette microcontroller 1004 determines by weight or volume whether a completion amount (e.g., 880 mL) has been extracted. This situation is shown in Figure 17L, in which case the plasma 1704 has been extracted and is still present in the loop outlet tube 112 and supplied to the plasma collection bottle 122 through the plasma tube 120. If it is an incomplete blood collection (i.e., the plasma collection bottle 122 has not reached the desired weight or volume limit), process 1400 is returned to step 1428. If it is a complete blood collection, method 1400 will be YES and proceed to the final return step 1432.

[0186] The time to complete the pull-in process 1420 is reduced by performing the return step 1428 when it is determined that the RBC interface 1709 is in its radially innermost position, rather than when platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach the line sensor 812, thereby reducing the overall time to complete method 1400.

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

[0188] [Table 11]

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

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

[0191] [Table 12]

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

[0193] Following or as part of the final return 1432, saline solution 1712 is also returned to the donor 102 in step 1436, as illustrated in Figure 17O. In step 1436, the cassette microcontroller 1004 opens the saline flow control valve 288, leaving the first fluid control valve 320A and the second fluid control valve 320B open. The return pump 212 continues to operate counterclockwise. The centrifuge microcontroller 1008 stops the rotation of the filler 460. The saline solution 1712 from the saline bag 118 is pushed back to the donor 102 through the blood component separation bladder 536, the drip chamber 354, and various tubes. Any remaining blood components in the blood component collection set 500 are pushed back to the donor 102 along with some of the saline solution 1712. Saline solution 1712 is used for fluid replenishment to donor 102 and is required in several jurisdictions. This return of saline solution 1712 continues until a predetermined amount of saline solution 1712, determined by the weight or volume of saline solution 1712 released from saline bag 118, is supplied to the user. Plasma collection is completed as shown in Figure 17O. The state of the various components of the apheresis system 200 during this step is as shown below.

[0194] [Table 13]

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

[0196] In step 1508, the channel is evacuated. In at least one exemplary embodiment, the cassette microcontroller 1004 operates the suction pump 208 counterclockwise, as shown in Figure 17P, to continue pushing the saline solution 1712 almost completely out of the blood component separation bladder 536 and the rest of the blood component collection set 500. At some point, almost the entire volume of blood components and / or saline solution 1712 is pushed back into the donor 102, in which case all pumps 216, 208, and 212 are stopped. The fluid control valve 320A, the first fluid control valve 320A, the saline flow control valve 288, and any other valves are closed by the cassette microcontroller 1004. Once the various valves are closed, there should be only a small amount of saline solution 1712 remaining in the blood component collection set 500, or no saline solution 1712 at all. The state of the apheresis system 200 is shown in Figure 17Q. The state of the various components of the apheresis system 200 is as follows during this step.

[0197] [Table 14]

[0198] The blood component collection set 500 is sealed in step 1512, as shown in Figure 17R. Sealing the blood component collection set 500 may include clamping the donor supply tube 104 leading to the donor 102 and fusion sealing the tube at various points. As the tube is a thermoplastic, as shown in Figure 17R, the sealing is performed by fusion sealing of the tube. For example, the anticoagulant tube 110, the saline tube 116, the plasma tube 120 (upstream of the plasma flow control valve 286), and the donor supply tube 104 are all heat-fused to separate the AC bag 114, the plasma collection bottle 122, the saline bag 118, and the donor 102 from the rest of the blood component collection set 500. The state of the various components of the apheresis system 200 during this step is as shown below.

[0199] [Table 15]

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

[0201] [Table 16]

[0202] In step 1520, the blood component collection set 500 is removed from the apheresis system 200. This involves reversing at least some of the procedures described in relation to Figures 13 and 16. The state of the various components of the apheresis system 200 during this step is as shown below.

[0203] [Table 17]

[0204] Once removed, the used blood component collection set 500 is disposed of as medical waste. As shown in Figure 17S, the plasma collection bottle 122 is sealed against the plasma tube 120. The sealed area prevents 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 is removed and used in the procedure where the plasma is required. The remaining components may be disposed of as medical waste. As shown in Figure 17T, the procedure is completed in step 1524. The state of the various components of the apheresis system 200 at the end of the procedure is as follows.

[0205] [Table 18]

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

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

[0208] In step 1612, a blood component collection set 500, including a blood component isolation bladder 536, is prepared. The blood component collection set 500 is packaged and removed from the package. The user exposes the blood component isolation bladder 536 and inserts it into the isolation insertion channel 466. This involves ensuring that the free end of the bladder 540B is securely positioned in the channel path jog 476 of the isolation insertion channel 466 and that the filler loop connector 532 is securely positioned in the loop connection area 454. With the blood component isolation bladder 536 properly positioned, in step 1616, the user deforms the blood component isolation bladder 536 to the shape of the isolation insertion channel 466 and the channel path jog 476, as shown in Figures 5F to 5H. In this way, the user deforms the blood component isolation bladder 536 into a substantially circular shape or any other shape to conform to the shape of the isolation insertion channel 466.

[0209] In step 1620, as shown in Figures 5G to 5H, the user inserts the blood component separation bladder 536, which has been deformed to conform to its shape, into the separation insertion channel 466 of the filler 460, with the free end 540B of the blood component separation bladder 536 inserted into the channel path jog 476 of the separation insertion channel 466. The user inserts the blood component separation bladder 536 into the separation insertion channel 466 at approximately the center position within the filler insertion chamber 492. Due to centrifugal force, the blood component separation bladder 536 is automatically positioned in the correct location within the filler insertion chamber 492. However, if the blood component separation bladder 536 is not positioned when centrifugal force acts on it, the blood component separation bladder 536 will be removed from the separation insertion channel 466. Once positioned, the blood component separation bladder 536 is fixed in place.

[0210] In step 1624, the user connects the filler loop connector 532 of the blood component separation bladder 536 to the loop connection area 454 of the separation insertion channel 466. The user may also enable mechanical connection by snapping the filler loop connector 532 into the loop connection area 454. The dimensions and physical features of the filler insertion chamber 492 ensure that the filler loop connector 532 is stable within the loop connection area 454, and that the blood component separation bladder 536 is held in a stable position so that it can enter the center of the filler insertion chamber 492 during the operation of the centrifuge 400. The portion of the flexible loop 524 remaining outside or on the outside of the filler 460 is attached to the loop capture arm 416. This attachment of the flexible loop 524 enables the 1ω / 2ω action of the centrifuge 400.

[0211] After the flexible loop 524 is installed, in step 1628, the upper housing 404B is rotated 180 degrees to a predetermined position. Thus, the filler 460 is rotated into the system housing 204 by the hinge axis 406 (e.g., the hinge). The centrifuge split housing 404 is rotated with the blood component collection loop 520 passing through the loop access clearance 436 of the centrifuge split housing 404. Once the blood component collection loop 520 is installed in the loop installation position 520A, a portion of the blood component collection loop 520 is partially housed, held, and / or supported by the loop storage bracket 426, as described in relation to Figures 4A-4C. The access panel 224 is rotated to the closed position, enabling the operation of the system 200.

[0212] With regard to apheresis methods and systems, typical systems and methods of this disclosure have been described. However, in order to avoid unnecessarily obscuring this disclosure, some known structures and apparatus have been omitted from the above description. This omission should not be construed as limiting the scope of the disclosure as described in the claims. Certain detailed descriptions are provided to give an understanding of this disclosure. However, it should be understood that this disclosure may be carried out in various ways other than those described herein.

[0213] Furthermore, while the embodiments, configurations, and / or configurations illustrated herein represent various components of a system, specific components of the system may be located remotely in a remote part of a distributed network such as a LAN and / or the Internet, or within a dedicated system. Therefore, it should be understood that system components can be combined into one or more devices such as a cassette node 904 and a centrifuge node 908, or that system components can be located at specific nodes in a distributed network such as an analog and / or digital telecommunications network, a packet-switch network, or a circuit-switched network. From the above description, it should also be understood that, for computational efficiency, system components can be located at any location within the distributed network of the components without affecting the operation of the system. For example, various components can be located in a PBX and media server, a switch such as a gateway, one or more communication devices, one or more user sites, or any combination thereof. Similarly, one or more functional parts of the system can be placed between a telecommunications device and associated computer equipment.

[0214] Furthermore, it should be understood that the various links connecting the elements may be wired links or wireless links, or any combination thereof, or any other known or later developed elements capable of supplying and / or communicating data to and from the connected elements. These wired or wireless links may also be secure links and capable of transmitting encrypted information. The transmitting medium used as a link may be any carrier suitable for electrical signals, including, for example, coaxial cables, copper wires, and optical fibers, or it may take the form of sound waves or light waves, such as those generated during radio or infrared data communications.

[0215] Furthermore, while flowcharts have been discussed and illustrated to illustrate specific sequences of events, it should be understood that modifications, additions, and omissions to these sequences can be made without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0216] Multiple variations and modifications of this disclosure can be used. Some features of this disclosure can be provided without giving rise to other features.

[0217] In further other embodiments, the systems and methods of this disclosure may be implemented in connection with a dedicated computer, a programmed microprocessor or microcontroller and peripheral integrated circuit elements, an ASIC or other integrated circuit, a digital signal processor, logic circuits such as hardwired electronic equipment or discrete element circuits, a programmable logic device or gate array, e.g., a PLD, PLA, FPGA, PAL, a dedicated computer, any equivalent means, etc. In general, any apparatus or means capable of implementing the methodologies shown herein may be used to implement various aspects of this disclosure. Typical hardware that may be used for the disclosed embodiments, configurations, and aspects includes computers, portable devices, telephones (e.g., mobile phones, internet-enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., one or more microprocessors), memory, non-volatile storage devices, input devices, and output devices. Furthermore, other software implementations, including but not limited to distributed processing or component / object distributed processing, parallel processing, or virtual machine processing, may also be constructed to implement the methods described herein.

[0218] In further embodiments, the disclosed method can be readily implemented in connection with 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 partially or fully implemented with hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement the system relating to this disclosure depends on the system's speed and / or efficiency requirements, specific functions, and the specific software or hardware system or microprocessor or microcomputer system being used.

[0219] In further embodiments, the disclosed method may be partially implemented in software that can be stored on a storage medium and executed in a general-purpose computer, dedicated computer, microprocessor, etc., programmed in cooperation with a controller and memory. In these cases, the system and method of this disclosure may be implemented as a program embedded in a personal computer, such as an applet, JAVA® or CGI script; as a resource residing in a server or computer workstation; as a routine embedded in a dedicated measurement system or system component; or the like. The system may also be implemented by physically embedding the system and / or method into a software and / or hardware system.

[0220] This disclosure describes components and functions implemented in aspects, embodiments, and / or configurations relating to specific standards and protocols, but the aspects, embodiments, and / or configurations are not limited to such standards and protocols. Other similar standards and protocols not mentioned herein exist and are deemed to be included in this disclosure. Furthermore, the standards and protocols mentioned herein, as well as other similar standards and protocols not mentioned herein, are periodically superseded by faster or more effective equivalents having substantially the same functionality. Such alternative standards and protocols having the same functionality are deemed to be equivalents included in this disclosure.

[0221] This disclosure of various aspects, embodiments, and / or configurations includes, substantially, components, methods, processes, systems, and / or devices, including various aspects, embodiments, configuration embodiments, subcombinations, and / or subsets thereof, which are illustrated and described herein. A person skilled in the art will be able to understand, after understanding this disclosure, how to create and use the disclosed aspects, embodiments, and / or configurations. This disclosure of various aspects, embodiments, and / or configurations includes providing devices and processes in various aspects, embodiments, and / or configurations, for example, in the absence of items that may have been used in prior devices or processes, in the absence of items not illustrated and / or described herein, or in the absence of items in those various aspects, embodiments, and / or configurations, including in the absence of items that may have been used in prior devices or processes, to improve performance, gain ease, and / or reduce implementation costs.

[0222] The above description has been given for illustrative and explanatory purposes. It is not intended to limit the disclosure to one or more forms disclosed herein. For example, in the above detailed description, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of simplifying the disclosure. Features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those described above. This method of disclosure should not be interpreted as reflecting an intention that the claims require more features than those explicitly enumerated in each claim. Rather, as reflected in the following claims, the aspects of the invention have fewer features than all the features of the single disclosed aspect, embodiment, and / or configuration described above. Accordingly, the following claims are incorporated into this detailed description, and each claim exists on its own as a separate preferred embodiment of the disclosure.

[0223] Furthermore, while the text of the specification has included descriptions of one or more aspects, embodiments, and / or configurations, and specific variations and modifications, other variations, combinations, and modifications may be within the scope of the disclosure, for example, within the scope of the skills and knowledge of a person skilled in the art, after understanding the disclosure. It seeks to obtain, to the extent permitted, rights including other aspects, embodiments, and / or configurations, including substitute and / or equivalent structures, functions, scopes, or steps, whether or not such substitute and / or equivalent structures, functions, scopes, or steps are disclosed herein, and without intending to publicly use any patentable subject matter.

Claims

1. A method for operating an apheresis system for collecting blood components, wherein the method of operation is: The apheresis system operates to draw whole blood into a centrifuge, The apheresis system operates by rotating the centrifuge to apply centrifugal force to the whole blood, thereby separating the whole blood into at least a first blood component and a second blood component different from the first blood component. The apheresis system operates to extract the first blood component from the centrifuge, A detection step in which the apheresis system operates to detect when the second blood component is about to be extracted from the centrifuge, The apheresis system operates to move at least the second blood component away from the centrifuge while the centrifuge continues to rotate, after the second blood component has been detected. It has, The aforementioned detection step is, The apheresis system operates to monitor the inlet pressure of the whole blood entering the centrifuge, The apheresis system operates to determine the back pressure at the inlet of the centrifugal separator based on the inlet pressure, The apheresis system operates to detect the radial position of the interface between the first blood component and the second blood component in the centrifuge by relating the change in back pressure from the start of extraction of the first blood component to the radial position of the interface between the first blood component and the second blood component in the centrifuge, Having, How to operate the apheresis system.

2. In the method for operating the apheresis system according to claim 1, The first blood component includes plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof. How to operate the apheresis system.

3. In the method of operating the apheresis system according to claim 2, The second blood component includes plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof. How to operate the apheresis system.

4. In the method of operating the apheresis system according to claim 2, The second blood component mentioned above includes red blood cells, How to operate the apheresis system.

5. In the method for operating the apheresis system according to claim 1, When separating the first blood component from the whole blood, the apheresis system operates such that the centrifuge rotates at a first speed. How to operate the apheresis system.

6. In the method of operating the apheresis system according to claim 5, The apheresis system operates such that the centrifuge continues to rotate at a first speed when the separated first blood component is flowed back towards the centrifuge. How to operate the apheresis system.

7. In the method of operating the apheresis system according to claim 6, When the whole blood is drawn into the centrifuge, the apheresis system operates such that the centrifuge rotates at a second speed. How to operate the apheresis system.

8. In the method of operating the apheresis system according to claim 7, The second speed is slower than the first speed. How to operate the apheresis system.

9. In the method for operating the apheresis system according to claim 1, The centrifuge is configured to receive a blood component collection set, and the blood component collection set is configured to receive the first blood component. How to operate the apheresis system.

10. In the method of operating the apheresis system according to claim 9, The blood component collection set includes a blood component separation bladder for separating the first blood component. How to operate the apheresis system.

11. In the method of operating the apheresis system according to claim 10, The centrifuge includes a filler, which is configured to rotate the blood component separation bladder. How to operate the apheresis system.

12. In the method of operating the apheresis system according to claim 11, The filler includes a separation and insertion channel configured to receive the blood component separation bladder. How to operate the apheresis system.

13. In the method for operating the apheresis system according to claim 1, The step of monitoring the inlet pressure includes the operation of the apheresis system which is configured to receive a signal output from a sensor located at the inlet of the centrifuge, How to operate the apheresis system.

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