Method and system for collecting high-throughput blood component

Abstract

To provide a method and a system capable of performing a blood collection process more efficiently for a donor at a higher speed.SOLUTION: Disclosed is an embodiment including a device for separating a component from blood. The embodiment includes separation of blood plasma from whole blood. Also disclosed is an embodiment including a method and a device for positioning a part of a disposable article, for example, a loop 520, in a medical device. The embodiment includes use of a surface for automatically guiding loops and positioning the loops to predetermined positions.SELECTED DRAWING: Figure 4A

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 488,404, filed on April 21, 2017, entitled "Disposable Loading" and U.S. Provisional Patent Application No. 62 / 539,053, filed on July 31, 2017, entitled "Component Collection", under 35 U.S.C.§119(e). The entire disclosure content of the above applications is incorporated herein by reference in its entirety for all purposes and with respect to all that they teach.

[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 with respect to blood donor donation / collection. The first method is that after the donation of whole blood from the donor, a centrifugation process follows to separate the blood components from the whole blood based on the density of the blood components. The desired components are manually, semi - automatically, or automatically transferred to a collection container during or (in some cases) after the whole blood is subjected to the force provided by a centrifuge. The other method is apheresis collection which requires special equipment.

[0004] The apheresis method withdraws whole blood from the donor while the donor is connected to special equipment. The whole blood can be centrifuged again to collect only the desired blood components (e.g., plasma) and return all other blood components that are not desired during the same blood collection back to the original donor. The donor is connected to the apheresis device during the separation and collection of the blood components.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Unfortunately, the apheresis process can be very time-consuming and unpleasant. In many cases, the donor must remain connected to the device for a predetermined period of time to have blood components collected. Therefore, it is still desirable for apheresis collection sites to perform blood collection procedures more efficiently.

[0006] There is a need for a system for plasma or other blood components that can reduce blood collection time and increase donor comfort. Embodiments provided herein can increase the efficiency of the blood collection process by pushing or returning unwanted blood components to the donor using the separated blood components without stopping and restarting the centrifuge. Thus, the embodiments herein make the blood collection process more efficient and faster for the donor.

Means for Solving the Problems

[0007] Embodiments may provide a method and apparatus for positioning a disposable part (e.g., a loop) within a medical device. Embodiments can involve the use of surfaces for automatically guiding the loop. In some embodiments, the medical device may be a blood separation device such as an apheresis device.

[0008] The previously mentioned needs and other needs are addressed in various aspects, embodiments, and / or configurations. Although the present disclosure is provided with respect to exemplary embodiments, it should be understood that the individual aspects of the present disclosure can be claimed separately.

[0009] An embodiment includes an assembly for separating one component from a multi-component fluid, the assembly including a filler having channels for holding a separation bladder of a disposable item, the channels having two opposing walls, and a loop rotation positioning guide having a plurality of bearings, the loop rotation positioning guide holding a flexible loop of the disposable item when the separation bladder is mounted within the channels.

[0010] Aspects of the assembly include the loop rotation positioning guide including a stopper plate. Aspects of the assembly include the flexible loop contacting the stopper plate when held within the loop rotation positioning guide. Aspects of the assembly include the assembly being part of an aphoresis device. Aspects of the assembly include the assembly being connected to a rotor that rotates the loop rotation positioning guide about an axis of rotation. Aspects of the assembly include the plurality of bearings including a plurality of pairs of roller bearings.

[0011] An embodiment includes a centrifuge assembly including 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 disposed within the internal cavity of the centrifuge housing and configured to rotate about the axis of rotation relative to the centrifuge housing, and a fluid line loop arm attached to a portion of the centrifuge housing and extending along a length of the outer surface of the centrifuge housing, the fluid line loop arm including a bearing set disposed at a point along the length of the outer surface, the bearing set configured to contact a tube portion of the interconnected fluid line loop to hold the fluid line loop in an engaged position relative to the centrifuge housing while allowing the fluid line loop to rotate in the engaged position.

[0012] Aspects of the centrifuge assembly include that the bearing set comprises a pair of roller bearings. Aspects of the centrifuge assembly include that the bearing set comprises a plurality of pairs of roller bearings. Aspects of the centrifuge assembly include that the centrifuge assembly is part of an apheresis device. Aspects of the centrifuge assembly include that a fluid line loop is attached at a first end thereof to a stationary non-rotating part of the apheresis device via a first positive positioning connector, and the fluid line loop is interconnected at a second end thereof to a fluid separation body within an internal cavity via a second positive positioning connector. Aspects of the centrifuge assembly include that the second end of the fluid line loop rotates with the fluid separation body. Aspects of the centrifuge assembly include that the fluid line loop is physically and fluidly attached to a disposable fluid separation bladder at the second positive positioning connector. Aspects of the centrifuge assembly include that the fluid line loop comprises a plurality of lumens, the fluid separation bladder comprises a first flexible sheet attached to a second flexible sheet to form a fluid path, and a first portion of the fluid path is narrower than a second portion of the fluid path.

[0013] Embodiments include a method for automatically attaching a fluid line loop to a centrifuge assembly, the method comprising attaching the fluid line loop at a first end to a fluid separation body of the centrifuge assembly, and rotating the fluid separation body in a first rotational direction relative to a housing of the centrifuge assembly, 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 part of the housing, the channel including a bearing disposed in a bearing set attached to the loop arm, the bearing holding the fluid line loop in a predetermined position relative to the housing as the centrifuge assembly rotates.

[0014] Aspects of the method include the bearing contacting a portion of the fluid line loop as the fluid line loop rotates relative to the housing at a predetermined position within the channel. Aspects of the method include the centrifuge housing rotating about the axis of rotation in a first direction of rotation at a first angular velocity, and the fluid separation body being rotated about the axis of rotation at a different second angular velocity by a torsional force provided by the fluid line loop. Aspects of the method include the second angular velocity being approximately twice the first angular velocity. Aspects of the method include the fluid line loop being physically and fluidly attached to a disposable fluid separation bladder that is at least partially disposed within the fluid separation body. Aspects of the method further include attaching a second end of the fluid line loop to a point fixed in the direction of rotation of the apheresis device, and rotating the centrifuge assembly about the axis of rotation relative to a point fixed in the direction of rotation of the apheresis device via a rotor-motor assembly of the apheresis device.

[0015] Embodiments include a method for collecting blood components by apheresis, the method including drawing whole blood from a donor into a centrifuge, rotating the centrifuge to apply a centrifugal force to the whole blood to separate the whole blood into at least a first blood component and a third blood component, separating the first blood component from the whole blood, 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, while the centrifuge continues to rotate, pushing the separated first blood component back into the centrifuge and moving at least the third blood component out of the centrifuge and back to the donor.

[0016] Aspects of the method include that the first blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. Aspects of the method include that the second blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood, and the third blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. Aspects of the method include that the first blood component is two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. Aspects of the method include that the centrifuge rotates at a first speed when separating the first blood component from whole blood. Aspects of the method include that the centrifuge continues to rotate at the first speed when returning the separated first blood component back into the centrifuge. Aspects of the method include that the centrifuge rotates at a second speed when drawing whole blood from the donor into the centrifuge. Aspects of the method include that the second speed is slower than the first speed. Aspects of the method include that the first blood component is separated from whole blood within a blood component collection set inserted into the centrifuge. Aspects of the method include that the centrifuge includes a filler that rotates a blood component collection bladder associated with the blood component collection set. Aspects of the method include that the blood component collection bladder is inserted into and held in a collection insertion channel formed in the filler.

[0017] The embodiment includes an apheresis system, the apheresis system having a lumen and being fluidly associated with a needle, and including a first tube 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 apply a centrifugal force to the whole blood to separate the whole blood into at least a first blood component and a third blood component, a blood component collection bladder inserted into the centrifuge and fluidly associated with the first tube for separating the first blood component from the whole blood, a second tube fluidly associated with the blood component collection bladder for moving the first blood component from the blood component collection bladder, a collection container fluidly associated with the second tube for extracting the first blood component from the apheresis system, a sensor positioned physically proximate to the second tube for detecting that a second blood component has been extracted from the whole blood, and a return pump engaged with the second tube for returning the separated first blood component through the second tube to the blood component collection bladder while the centrifuge continues to rotate after the second blood component has been detected by the sensor, and for moving at least the third blood component from the blood component collection bladder back to the donor.

[0018] Aspects of the apheresis system include that the first blood component is plasma and the second blood component is platelets, red blood cells, and / or high hematocrit blood. Aspects of the apheresis system further include an anticoagulant pump for drawing an anticoagulant from an anticoagulant bag and mixing the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tube. Aspects of the apheresis system include that the centrifuge includes a filler for rotating the blood component collection bladder. Aspects of the apheresis system include that the blood component collection bladder is inserted into and held in a collection insertion channel formed in the filler.

[0019] An embodiment includes 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, fluidly associated with the needle, and configured to move the whole blood through the lumen, the first tube being engaged with a draw pump that draws the whole blood from the donor; a blood component collection bladder inserted into a centrifuge, fluidly associated with the first tube, and configured to separate a first blood component and a third blood component from the whole blood; a second tube fluidly associated with the blood component collection bladder and configured to move the first blood component from the blood component collection bladder; a collection container fluidly associated with the second tube and configured to extract the first blood component from the apheresis system, wherein a sensor is physically proximate to the second tube to detect that a second blood component has been extracted from the whole blood, and after the second blood component is detected by the sensor, a return pump engaged with the second tube returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor.

[0020] Aspects of the blood component collection set include that the first blood component is plasma and the second blood component is platelets. Aspects of the blood component collection set include that the draw pump is disengaged when the return pump returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor. Aspects of the blood component collection set include that the blood component collection bladder is inserted and held within a filler that rotates the blood component collection bladder in a centrifuge. Aspects of the blood component collection set include that the blood component collection bladder is inserted into a collection insertion channel formed within the filler to hold the blood component collection bladder.

[0021] An embodiment includes a filler for holding a separation bladder from which components are separated from a composite fluid. The filler includes a channel for holding the separation bladder during separation of components from the composite fluid. The channel includes a first wall and a second wall facing the first wall. A first end of the channel is adjacent to the central portion of the filler, and the channel spirals towards the outer periphery of the filler.

[0022] Aspects of the filler include that the upper end of the channel is narrower than the central portion of the channel. Aspects of the filler include that at least a part of the second wall has a concave surface. Aspects of the filler include that the second end of the channel is positioned such that it receives a higher gravity than the first end during separation. Aspects of the filler include that the upper end of the channel performs reinforcement for the separation bladder during separation.

[0023] An embodiment includes a fluid separation filler, the fluid separation filler including a body having a rotation axis disposed at a substantially mass center of the body, and a fluid collection insertion channel disposed within the body and following a substantially spiral path that spirally extends outward from a first point near the rotation axis to a second point near the outer periphery of the body. The fluid collection insertion channel curves outward towards the circumferential portion of the body near an end of the substantially spiral path that defines a third point of the fluid collection insertion channel that is disposed furthest from the rotation axis.

[0024] The embodiment of the fluid separation filler further includes a fluid collection chamber disposed within the main body and following a part of a substantially helical path, and a fluid collection insertion channel that connects to the fluid collection chamber and defines an access area between the interior of the fluid collection chamber and the exterior of the main body. The embodiment of the fluid separation filler includes that the fluid collection chamber is configured to receive a disposable fluid collection bladder. The embodiment of the fluid separation filler includes that the dimension from the axis of rotation to a third point of the substantially helical path is greater than the dimension from the axis of rotation to a second point of the substantially helical path. The embodiment of the fluid separation filler includes that the width of the fluid collection chamber at a point along the substantially helical path is greater than the width of the fluid collection insertion channel at a point along the substantially helical path. The embodiment of the fluid separation filler includes that the fluid collection chamber further includes a first wall following the innermost part of the substantially helical path and a second wall substantially parallel to the first wall and following the outermost part of the substantially helical path. The embodiment of the fluid separation filler includes that the fluid collection chamber further includes one or more tapered walls disposed between the first wall and the second wall, and the one or more tapered walls are configured to guide the disposable fluid collection bladder to a seating position within the fluid collection chamber. The embodiment of the fluid separation filler includes that the fluid inlet for the disposable fluid collection bladder when installed within the fluid collection chamber is disposed adjacent to the axis of rotation, and the first fluid path of the disposable fluid collection bladder follows a substantially helical path outwardly toward the end of the disposable fluid collection bladder disposed adjacent to a third point of the fluid collection insertion channel disposed farthest from the axis of rotation, and is fluidly interconnected with a second fluid path that extends inwardly in a direction away from the first fluid path of the disposable fluid collection bladder and following a substantially helical path from the third point to the fluid outlet for the disposable fluid collection bladder disposed adjacent to the axis of rotation. The embodiment of the fluid separation filler includes that the fluid inlet and the fluid outlet are part of a connector attached to the disposable fluid collection bladder, and the main body of the fluid separation filler includes a connection point that engages with the connector.The aspect of the fluid separation filler includes that the connector includes at least one key function part, the connection point includes at least one fitting key function part, and the key function part includes positively positioning the connector with respect to the connection point.

[0025] The embodiment includes a centrifuge assembly, the centrifuge assembly having an internal cavity and including a centrifuge housing that rotates about the axis of rotation of the centrifuge assembly, and a fluid separation body that is at least partially disposed within the internal cavity of the centrifuge housing and is configured to rotate relative to the centrifuge housing about the axis of rotation. The fluid separation body includes a fluid collection insertion channel that is disposed within the fluid separation body and follows a generally helical path that extends outwardly in a spiral from a first point adjacent to the axis of rotation to a second point adjacent to the outer periphery of the fluid separation body. The fluid collection insertion channel curves outwardly toward the outer periphery of the body near an end of the generally helical path that defines a third point of the fluid collection insertion channel that is disposed furthest from the axis of rotation.

[0026] Aspects of the centrifuge assembly include that the fluid separation body further comprises a fluid collection chamber disposed within the body and following a portion of a generally helical path, and a fluid collection insertion channel connects to the fluid collection chamber to define an access region between the interior of the fluid collection chamber and the exterior of the fluid separation body. Aspects of the centrifuge assembly further comprise a disposable fluid collection bladder disposed within the fluid collection chamber and following a generally helical path, the disposable fluid collection bladder including a fluid inlet disposed adjacent to the axis of rotation, and a first fluid path of the disposable fluid collection bladder follows a generally helical path outwardly toward an end of the disposable fluid collection bladder disposed adjacent to a third point of the fluid collection insertion channel disposed farthest from the axis of rotation, and is fluidly interconnected with a second fluid path that is separated from the first fluid path of the disposable fluid collection bladder and extends inwardly in a direction toward a fluid outlet of the disposable fluid collection bladder disposed adjacent to the axis of rotation following a generally helical path from the third point. Aspects of the centrifuge assembly include that the centrifuge assembly is part of an apheresis device. Aspects of the centrifuge assembly include that the centrifuge housing is divided into an upper housing and a lower housing, the upper housing includes an internal cavity, the upper housing is rotatable between an open state and a closed state about a pivot axis offset from the axis of rotation and generally perpendicular to the axis of rotation, and the fluid collection insertion channel of the fluid separation body is accessible in the open state and inaccessible in the closed state.

[0027] The embodiment includes a blood component collection loop, the blood component collection loop including a flexible loop and 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 positioned in the centrifuge.

[0028] Aspects of the blood component collection loop include that the blood component collection loop is part of a blood component collection set, and the blood component collection set is associated with an apheresis system. Aspects of the blood component collection loop include that a loop rotation positioning guide is attached to a rotor that rotates the loop rotation positioning guide and the flexible loop around an axis of rotation. Aspects of the blood component collection loop include that the blood component collection loop is at least partially positioned by a loop positioning stopper plate. Aspects of the blood component collection loop include that the flexible loop is curved around a centrifuge. Aspects of the blood component collection loop include that the flexible loop is also held in a predetermined position by a loop storage bracket. Aspects of the blood component collection loop include that at least a portion of the loop rotation positioning guide includes a loop torsion support bearing. Aspects of the blood component collection loop include that the loop torsion support bearing includes a pair of roller bearings. Aspects of the blood component collection loop include that the loop torsion support bearing allows the flexible loop to be twisted. Aspects of the blood component collection loop include that twisting causes the filler to rotate at an angular velocity greater than that of the centrifuge. Aspects of the blood component collection loop include that the flexible loop can include two or more lumens for moving whole blood and / or blood components within the flexible loop.

[0029] An embodiment includes an assembly for mounting a flexible loop, the assembly including a loop rotation positioning guide having a channel for holding a flexible loop of a blood component collection set, a loop torsion support bearing disposed within the channel as part of the loop rotation positioning guide for supporting the flexible loop, and a loop capture arm positioned adjacent to the channel, connected to the loop rotation positioning guide, guiding the flexible loop into the channel, and contacting the loop torsion support bearing.

[0030] The aspects of the assembly include that the assembly is part of an apheresis device, and the loop rotation positioning guide is connected to a centrifuge that rotates the loop rotation positioning guide and the flexible loop around the axis of rotation. The aspects of the assembly include that the loop rotation positioning guide further includes a loop positioning stopper plate for further positioning the flexible loop. The aspects of the assembly further include a loop storage bracket that is positioned within a plane with the loop rotation positioning guide and is disposed in the centrifuge to further capture the flexible loop.

[0031] Embodiments include a method for automatically attaching a flexible loop to an assembly, the method including 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 the first end of the flexible loop to a loop connection region of a filler, wherein a torsional force based on the twist 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 in the centrifuge.

[0032] Aspects of the method include that the flexible loop engages with a loop twist support bearing disposed within a channel formed by the loop rotation positioning guide, and the loop twist support bearing supports the flexible loop. Aspects of the method include that when rotating to guide the flexible loop into the channel and bring it into contact with the loop twist support bearing, a loop capture arm contacts the flexible loop. Aspects of the method include that the loop rotation positioning guide further includes a loop positioning stopper plate to prevent the flexible loop from over-rotating past the channel. Aspects of the method include that a loop storage bracket that is positioned within a plane with the loop rotation positioning guide and is disposed in the centrifuge further captures and holds the flexible loop.

[0033] The embodiment includes a soft cassette, the soft cassette including a first cassette port, a second cassette port, a direct current lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber disposed within the direct current lumen such that fluid passing through the direct current lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct current lumen adjacent to the first cassette port between the first cassette port and the drip chamber and fluidly connected to the direct current 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.

[0034] The aspect of the soft cassette includes that the fluid flow bypass path is composed of a first bypass branch fluidly connected to the direct current lumen adjacent to the first cassette port and a second bypass branch fluidly connected to the direct current lumen adjacent to the second cassette port. The aspect of the soft cassette includes that the fluid flow bypass path further includes a fluid pressure ring disposed between the first bypass branch and the second bypass branch and fluidly connected to these bypass branches. The aspect of the soft cassette includes that the direct current lumen has a first flexible region disposed between a first connection portion with the first bypass branch and the drip chamber, and this first flexible region enables the first fluid control valve to block the direct current lumen. The aspect of the soft cassette includes that the direct current lumen has a second flexible region disposed between a second connection portion with the second bypass branch and the drip chamber, and this second flexible region enables the second fluid control valve to block the direct current lumen. The aspect of the soft cassette includes that the direct current lumen has a third flexible region disposed within the first bypass branch, and this third flexible region enables the retraction fluid control valve to block the first bypass branch. The aspect of the soft cassette includes that the first cassette port is fluidly connected to a cassette inlet tube that moves fluid from the donor to the soft cassette or moves fluid from the soft cassette to the donor, and the second cassette port is fluidly connected to a loop inlet tube that moves fluid from the soft cassette to the centrifuge or moves fluid from the centrifuge to the soft cassette. The aspect of the soft cassette includes that when drawing fluid from the donor, the fluid passes through the fluid flow bypass path. The aspect of the soft cassette includes that when sending fluid to the donor, the fluid passes through the direct current lumen. The aspect of the soft cassette includes that when drawing fluid from the donor in the next draw, a part of the fluid sent to the donor through the direct current lumen last time is held in the drip chamber when the fluid passes through the fluid flow bypass path. The aspect of the soft cassette includes that the soft cassette is part of a blood component collection set. The aspect of the soft cassette includes that the blood component collection set is part of an apheresis system.

[0035] The embodiment includes a blood component collection set, the blood component collection set comprising 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 including a first cassette port fluidly connected to the cassette inlet tube, a second cassette port fluidly connected to the loop inlet tube, a direct current lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber disposed within the direct current lumen such that fluid passing through the direct current lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct current lumen adjacent to the first cassette port between the first cassette port and the drip chamber and fluidly connected to the direct current 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.

[0036] The aspect of the blood component collection set includes a fluid flow bypass path having a first bypass branch fluidly connected to a direct current lumen adjacent to a first cassette port, a second bypass branch fluidly connected to the direct current lumen adjacent to a second cassette port, and a fluid pressure loop disposed between the first bypass branch and the second bypass branch and fluidly connected to these bypass branches. The aspect of the blood component collection set includes that the direct current lumen has a first flexible region disposed between a first connection portion with the first bypass branch and a drip chamber, and this first flexible region enables a first fluid control valve to block the direct current lumen; the direct current lumen has a second flexible region disposed between a second connection portion with the second bypass branch and the drip chamber, and this second flexible region enables a second fluid control valve to block the direct current lumen; the direct current lumen has a third flexible region disposed within the first bypass branch, and this third flexible region enables a draw fluid control valve to block the first bypass branch. The aspect of the blood component collection set includes that when drawing fluid from the donor, the first fluid control valve and the second fluid control valve are closed to block the direct current lumen, and the draw fluid control valve is opened to enable whole blood to pass through the fluid flow bypass path. The aspect of the blood component collection set includes that when sending fluid to the donor, the first fluid control valve and the second fluid control valve are opened to enable the fluid to pass through the direct current lumen, and the draw fluid control valve is closed to block the fluid flow bypass path. The aspect of the blood component collection set includes that when drawing fluid from the donor in the next draw, a part of the fluid previously sent to the donor through the direct current lumen is retained in the drip chamber when the fluid passes through the fluid flow bypass path.

[0037] An embodiment includes a method for passing and moving a fluid through a soft cassette, the method comprising the step of providing a soft cassette, the soft cassette comprising a first cassette port fluidly connected to a cassette inlet tube, a second cassette port fluidly connected to a loop inlet tube, a straight-through lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber disposed within the straight-through lumen such that fluid passing through the straight-through lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the straight-through lumen adjacent to the first cassette port between the first cassette port and the drip chamber and fluidly connected to the straight-through 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. The method has steps including, when drawing whole blood from a donor, receiving the whole blood from the cassette inlet tube at the first cassette port fluidly connected to the cassette inlet tube, moving the whole blood through the fluid flow bypass path to the second cassette port, and preventing the whole blood from moving through the straight-through lumen. The method also includes, when returning red blood cells to the donor, receiving the red blood cells from the loop inlet tube at the second cassette port fluidly connected to the loop inlet tube, moving the red blood cells through the straight-through lumen and the drip chamber to the first cassette port, and preventing the red blood cells from moving through the fluid flow bypass path.

[0038] Aspects of the method include that when drawing fluid from the donor in a subsequent draw, a portion of the fluid previously sent to the donor through the straight-through lumen is retained within the drip chamber when the whole blood passes through the fluid flow bypass path again when returning the red blood cells to the donor.

[0039] Any one or more of the aspects / embodiments substantially disclosed herein.

[0040] Any one or more of the aspects / embodiments substantially disclosed herein, in combination with any one or more of the other aspects / embodiments substantially disclosed herein.

[0041] One or more means adapted to perform any one or more of the aspects / embodiments substantially disclosed herein.

[0042] The present disclosure can provide many advantages depending on specific aspects, embodiments, and / or configurations. By maintaining the rotational speed of the centrifuge while moving and returning unnecessary blood components to the donor, the time of the apheresis procedure can be reduced by up to 30% in some cases. This efficiency improvement enables faster and more comfortable donor provision. With a faster donor provision time, a donor center can obtain more donor provisions in a typical day, increasing productivity and revenue. Furthermore, if donor provision is faster, donors are more likely to return to donate again. If donor provision is faster, a donor center can also attract donors who are using other donor centers with slower donor provision speeds.

[0043] These and other advantages are apparent from the present disclosure.

[0044] The phrases "at least one", "one or more", and "and / or" are non-restrictive expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions "at least one of A, B, and C", "at least one of A, B, or C", "one or more of A, B, and C", "one or more of A, B, or C", and "A, B, and / or C" means only A, only B, only C, both A and B, both A and C, both B and C, or all of A, B, and C.

[0045] The term "a" or "an" entity refers to one or more of such entities. Thus, the terms "a" (or "an"), "one or more", and "at least one" can be used interchangeably herein. It should also be noted that the terms "comprising", "including", and "having" can be used interchangeably.

[0046] As used herein, the term "donor" can 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 the fluid to the apheresis system, but the fluid is processed, treated, manipulated, etc. before being provided back to the patient.

[0047] As used herein, the term "automated" and its variations refer to any process or operation that is performed without substantial human input when the process or operation is carried out. However, a process or operation can be automated if the input, even if the execution of the process or operation uses substantial or insubstantial human input, is received before the execution of the process or operation. Human input is considered substantial if such input affects the way the process or operation is carried out. Human input that merely consents to the execution of the process or operation is not considered "substantial".

[0048] As used herein, the term "computer-readable medium" refers to any tangible storage device and / or transmission medium involved in providing instructions to a process for execution. Such media can take many forms, including, but not limited to, non-volatile media, volatile media, and transmission media. Examples of non-volatile media include, for example, 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 medium, magneto-optical media, CD-ROM, any other optical media, punch cards, paper tapes, any other physical medium with patterns of holes, RAM, PROM, and EPROM, FLASH-EPROM, solid media such as memory cards, any other memory chip or cartridge, carrier waves described hereinafter, or any other medium readable by a computer. Digital files attached to electronic mails or other built-in information archives or sets of archives 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 can be of any type, such as relational, hierarchical, object-oriented, and / or the like. Accordingly, the present disclosure is considered to include tangible storage media or distribution media in which software implementations of the present disclosure are stored, equivalents recognized as prior art, and successor media.

[0049] As used herein, the term "module" refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or a combination of hardware and software capable of performing functions associated with its elements.

[0050] As used herein, the terms "determine", "calculate", and "compute", and variations thereof, are used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0051] The term "means" as used herein is to be understood to be given its broadest possible interpretation in accordance with Paragraph 6 of 35 U.S.C. § 112. Accordingly, a claim incorporating the term "means" shall cover all structures, materials, or acts described herein, and all equivalents thereof. Further, structures, materials, or acts, and equivalents thereof, shall include all those described in the summary of the invention, brief description of the drawings, detailed description, abstract, and the claims themselves.

[0052] The above is a simplified summary of the disclosure to provide an understanding of some aspects of the present disclosure. This summary is neither an extensive nor an inclusive overview of the present disclosure and its various aspects, embodiments, and / or configurations. It is not intended to identify key or critical elements of the present disclosure, nor to delineate the scope of the present disclosure, but rather to present selected concepts of the present disclosure in a concise form as a prelude to the more detailed description provided below. As will be appreciated, other aspects, embodiments, and / or configurations of the present disclosure utilizing one or more of the features described above or below in detail, alone or in combination, are contemplated.

Brief Description of the Drawings

[0053]

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DETAILED DESCRIPTION OF THE INVENTION

[0054] In the accompanying drawings, like components and / or features may have the same reference labels. Further, various components of the same type may be distinguished by letters following the reference label to distinguish between like components. If only a first reference label is used in the specification, the description applies to any one of the like components having the same first reference label regardless of the second reference label.

[0055] Embodiments of the present disclosure will be described in relation to apheresis methods and systems. The following embodiments may be described with respect to separating blood components from whole blood. However, the techniques of this example are provided for illustrative purposes only. Note that the embodiments are not limited to the following description. The embodiments are adapted to be used in products, processes, devices, and systems for separating any complex fluid. Accordingly, the present disclosure is not limited to the separation of blood components from whole blood.

[0056] Referring to FIG. 1, a perspective view of an operating environment 100 of an apheresis system 200 according to an embodiment of the present disclosure is shown. The operating environment 100 includes an apheresis system 200, a donor 102, and one or more connections (e.g., donor supply tube 104, cassette inlet tube 108A, anticoagulant tube 110, etc.) extending from and / or to the donor 102 to the apheresis system 200. As shown in FIG. 1, the donor supply tube 104 is fluidly connected to at least one blood vessel of the donor 102, such as a vein, by venipuncture. For example, a cannula connected to the end of the donor supply tube 104 is inserted through the skin of the donor 102 and into the target site, i.e., the 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 some embodiments, the flow path and connections may form an extracorporeal tubing circuit of the apheresis system 200.

[0057] The blood supplied from donor 102 passes through tube connector 106 along donor supply tube 104 and flows 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 (AC) source contained within an AC bag 114. The anticoagulant may be delivered at least through anticoagulant tube 110 and tube connector 106 to prevent coagulation of the blood within the apheresis system 200.

[0058] The anticoagulant can include, but is not limited to, one or more of citrate and / or unfractionated heparin. The AC bags and other bags or bottles described herein can be formed from, for example, one or more of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof, but are not limited thereto. The amount of AC within AC bag 114 can vary based on various factors including the mass of donor 102, the volumetric flow rate of blood from the donor, etc. In one example, the volume within AC bag 114 is 250 - 500 mL, although the volume within AC bag 114 may be larger or smaller than this volume.

[0059] In some embodiments, the apheresis system 200 may include a plasma collection bottle 122 or container, a saline fluid contained within the saline bag 118, and one or more lines or tubes 116, 120 (e.g., fluid transfer tubes, etc.) that connect the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200. The amount of saline prepared within the saline bag 118 is 500 - 800 mL, although the volume within the saline bag 118 may be larger or smaller than this volume. An example of the blood collection volume of a blood component (e.g., plasma) may be 880 mL. Accordingly, the plasma collection bottle 122 holds at least this amount of plasma. In some embodiments, the plasma collection bottle 122 may include a connection point disposed at or adjacent to or in physical proximity to the substantially bottom portion of the plasma collection bottle 122 (e.g., when the plasma collection bottle 122 is placed within the plasma collection cradle 232C as shown in FIG. 2A). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 for receiving and / or transporting plasma. Disposing the connection point at the bottom of the plasma collection bottle 122 allows the plasma contained within the plasma collection bottle 122 to flow retrograde from the plasma tube 120 through the line without trapping air bubbles or the like, as described herein. In some embodiments, the plasma collection bottle 122 may be configured as a flexible bag, a rigid container, and / or other container, and thus the plasma collection bottle 122 is not limited to a bottle or bottle-shaped container.

[0060] Figure 2A shows a perspective view of the apheresis system 200 described in FIG. 1. The apheresis system 200 provides a continuous whole blood separation process. In one embodiment, whole blood is drawn from the donor 102 and supplied to the blood component separator of the apheresis system 200 in a substantially continuous manner. 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 some embodiments, one or more of the separated blood components may be collected for subsequent use or returned to the donor 102. The blood is drawn from the donor 102 and directed to the centrifuge of the apheresis system 200 through the opening 220 of the access panel 224 of the apheresis system 200. In one embodiment, the tubes 104, 108A, 108B, 112, 116, 120 used in the extracorporeal tubing circuit together form a closed sterile disposable system or a blood component collection set, which will be further described below.

[0061] Examples of apheresis systems, plasma apheresis systems, and other separation systems that may be used 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® Spectra apheresis system, and the TRIMA ACCEL® automated blood collection system (these systems are manufactured by Terumo BCT of Lakewood, Colorado).

[0062] The operations of various pumps, valves, and blood component separation devices, or centrifuges may be controlled by one or more processors included in the apheresis system 200, and preferably may include a plurality of embedded computer processors that are part of a computer system. The computer system may include components that enable a user to interface with the computer system, such as, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / network devices (e.g., wired such as a modem / network card, or wireless such as WiFi), input devices such as a keyboard, touch screen, camera, and / or microphone, and output devices such as a display and audio system. Embodiments of the blood component separation device or centrifuge may include a graphical user interface with a display including an interactive touch screen to assist the operator of the apheresis system 200 in various aspects of its operation.

[0063] The apheresis system 200 may include a housing 204 and / or a structural frame, a cover 210, an access panel 224 disposed at the front portion 202 and / or the rear portion 206 of the apheresis system 200, and one or more supports 232A - 232C that hold, mount, and / or otherwise support hooks, rests, cradles, arms, protrusions, plates, and / or bags or containers 114, 118, 122. In some embodiments, the features of the apheresis system 200 may be described in relation to a coordinate system 103 and / or one or more of its axes. The housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extruded material, beams, etc.), to which one or more panels, the cover 210, doors, subassemblies, and / or components are attached. In one embodiment, at least one panel of the apheresis system 200 may include a mounting surface for a soft cassette assembly 300, one or more pumps 208, 212, 216, and / or a fluid valve control system 228 (e.g., plasma - saline valve control, etc.).

[0064] The access panel 224 may include one or more handles, locks, and a pivot axis or hinge axis (e.g., door hinge, piano hinge, continuous hinge, cleanroom hinge, etc.). In any case, the access panel 224 is selectively opened to provide access to the interior of the apheresis system 200, more specifically, to the blood separation assembly or centrifuge. In one embodiment, the access panel 224 may be accessible to attach and / or remove one or more components in a blood component collection set to the centrifuge. Details of the centrifuge are described in more detail herein, at least with respect to FIGS. 4A - 4L.

[0065] The interior of the apheresis system 200 may be divided into at least a centrifugal separation unit and a control unit. For example, the centrifugal separation unit includes a cavity configured to receive a centrifuge, a rotary motor, and related hardware. This area may be physically separated from the control unit by one or more walls of the cavity. In some embodiments, access to the control unit (configured to house or include, for example, a motor controller, a CPU or a processor, electronic devices, wiring, etc.) may be through a panel firmly fastened to the housing 204 and / or a panel separate from the access panel 224.

[0066] In some embodiments, 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, physiological saline, etc.) through the apheresis system 200. For example, the apheresis system 200 includes a draw pump 208 configured to control the blood flow to and / or from the donor 102 to the centrifuge of the apheresis system 200. The draw pump 208 may engage a portion of the loop inlet tube 108B disposed between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In some embodiments, the apheresis system 200 may include a return pump 212 configured to control the flow of separated blood components (e.g., plasma, etc.) from the centrifuge to the plasma collection bottle 122 and / or the reverse flow thereof. In addition to or instead of this, the return pump 212 may control the flow of physiological saline (e.g., supplied from the physiological saline bag 118) throughout the blood component collection set and / or the entire apheresis system 200. The anticoagulant pump 216 may engage 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 FIG. 2A, the pumps 208, 212, 216 may be at least partially disposed on the top cover 210 of the apheresis system 200.

[0067] Figures 2B and 2C show various perspective views of pumps 208, 212, 216 of the apheresis system 200 according to embodiments of the present disclosure. Although the draw pump 208 is illustrated and described in connection with FIGS. 2B and 2C, it should be understood that the other pump assemblies of the apheresis system 200, namely, the return pump 212 and the anticoagulant pump 216, may include a configuration that is substantially similar, if not identical, to the draw pump 208 being described.

[0068] The draw pump 208 may include a pump cover 236 or housing configured to at least partially receive the moving elements of the draw pump 208. In some embodiments, the pump cover 236 may include a hinged tube guard 240 configured to open and close about a tube guard pivot axis 242. In one embodiment, the tube guard 240 may be attached to the pump cover 236 via one or more fasteners disposed along the tube guard pivot axis 242. As shown in FIGS. 2B and 2C, blood supplied by the donor 102 may be conveyed or drawn into the centrifuge by the draw pump 208 in a first draw or centrifugal direction 250A. In addition to or instead of this, blood or other fluid may be conveyed or drawn by the draw pump 208 to the donor 102 in a donor direction 250B opposite to the centrifugal direction 250A.

[0069] In some embodiments, the draw pump 208 and / or other pumps 212, 216 may be a tube pump, a peristaltic pump, a diaphragm pump, and / or other pumps configured to manipulate the flow of fluid (e.g., blood, blood components, anticoagulants, saline, etc.) within at least a portion of a tube. For example, pumps 208, 212, 216 may include a motor operably interconnected with a rotating tube contact assembly. In operation, a tube (e.g., loop inlet tube 108B, loop outlet tube 112, anticoagulant tube 110, etc.) may be inserted into lead tube guides 244, tube pressure block 248, and end tube guides 252 adjacent to the rotating tube contact head. In one embodiment, the tube pressure block 248 may be moved away from the rotating tube contact head or pumps 208, 212, 216 to provide a capture clearance region, or vice versa. The rotating tube contact head includes a plurality of rotating pressure rollers 268, each configured to rotate about a respective pressure roller rotation axis 264. Each of the rotating pressure rollers 268 is disposed between a first rotating pump plate 272A and a second rotating pump plate 272B, where the plates 272A, 272B are configured to rotate about a pump rotation axis 260. In some embodiments, the rotating pressure rollers 268 are disposed on the outer periphery of the rotating pump plates 272A, 272B.

[0070] One or more of pumps 208, 212, 216 may include, without limitation, all Pulsafeeder® model UX-74130 peristaltic pumps manufactured by Pulsafeeder Inc. in Punta Gorda, Florida, pumps of the Pulsafeeder® MEC-O-MATIC series, or may operate similarly to these pumps. Other examples of pumps 208, 212, 216 include, but are not limited to, INTEGRA DOSE IT laboratory peristaltic pumps manufactured by INTEGRA Biosciences AG in Switzerland, and WELCO WP1200, WP1100, WP1000, WPX1, and / or peristaltic pumps of the WPM series, all manufactured by WELCO Co., Ltd in Tokyo, Japan.

[0071] When the tube is loaded into the lead tube guide 244, the tube pressure block 248, and / or the end tube guide 252, at least a part of the rotary pressure roller 268 engages with, contacts, or compresses the tube disposed between the rotary tube contact head and the tube pressure block 248. When the rotary pump plates 272A, 272B rotate about the pump rotary shaft 260, the rotary pressure roller 268 compresses the portion of the tube between the pumps 208, 212, 216 and the tube pressure block 248, and can surely move the fluid in that portion of the tube in the directions 250A, 250B in which the rotary pressure roller 268 moves. For example, when the rotary pump plates 272A, 272B rotate counterclockwise about the pump rotary shaft 260, the rotation of the rotary pressure roller 268 that compresses the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or send out the fluid in the centrifugal direction 250A. As another example, when the rotary pump plates 272A, 272B rotate clockwise about the pump rotary shaft 260, the rotation of the rotary pressure roller 268 that compresses the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or send out the fluid in the donor direction 250B. When not actively sending out, the pump 208 is maintained in a state where at least one rotary pressure roller 268 continues to block the tube 108B, or a state where the rotary pressure roller 268 does not block the tube 108B. Therefore, the pump 208 can also act as a "valve" for preventing or allowing fluid movement based on the stationary state. This ability is also possible for the pumps 212, 216.

[0072] The tube guard 240 and the pump cover 236 serve to protect the operator (e.g., a phlebotomist, an apheresis technician, etc.) and / or the donor 102 from accidental contact with one or more moving parts of the pumps 208, 212, 216. In one embodiment, the tube guard 240 is held in the closed position via one or more guard closing features 254 disposed in the tube guard 240, the lead tube guide 244, the tube pressurizing block 248, and / or the end tube guide 252. These guard closing features 254 may be magnets housed in the tube guard 240, the lead tube guide 244, the tube pressurizing block 248, and / or the end tube guide 252. In some embodiments, the pumps 208, 212, 216 may be stopped or made not to move / operate when the tube guard 240 is open. In this embodiment, a guard closing sensor may be included in the guard closing feature 254, the guides 244, 252, and / or the tube pressurizing block 248.

[0073] One or more fluid control valves are used to control the path or flow direction of the fluid conveyed throughout the tubes of the apheresis system 200. In some embodiments, the apheresis system 200 may include a plasma / saline valve control system 228 disposed adjacent to the saline bag 118 and / or the plasma collection bottle 122. The plasma / saline valve control system 228 is shown in the detailed perspective view of FIG. 2D.

[0074] As shown in FIG. 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 enables the connection of the loop outlet tube 112 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 disposed at a first end of the saline / plasma valve housing 276 and surrounding a portion of the loop outlet tube 112. The air detection sensor 284 may be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air within the loop outlet tube 112 and providing its signal to the controller of the apheresis system 200. Examples of the type of air detection sensor 284 include, for example, the SONOCHECK ABD05 manufactured by SONOTEC US Inc., or other similar sensors.

[0075] The saline / plasma valve housing 276 includes a plurality of receiving features (e.g., grooves, channels, receptacles, etc.) for receiving a portion of the tubes 112, 116, 120 and / or the saline / plasma tube y-connector 280. When detecting air within the loop outlet tube 112, the plasma / saline valve control system 228 selectively actuates one or more of the fluid control valves 286, 288. In some embodiments, the air detection result via the air detection sensor 284 is used to signal an operating step and / or cause a step of the control method described herein.

[0076] The plasma flow control valve 286 and / or the saline flow control valve 288 may be a solenoid valve, a linear actuator, a pinch valve, a clamp valve, a tube valve, and / or other operable valves configured to selectively change (e.g., block) the fluid passage associated with a particular portion of the tubes 112, 116, 120. As shown in FIG. 2D, the plasma flow control valve 286 may be configured to clamp a portion of the plasma tube 120 that is at least partially received within the receiving feature of the saline-plasma valve housing 276. The saline flow control valve 288 may be configured to clamp a portion of the saline tube 116 that is at least partially received within the receiving feature of the saline-plasma valve housing 276. In any case, the control valves 286, 288 include operable and extendable fingers that move from a retracted position or a partially retracted position to an extended position or a partially extended position to clamp a portion of the tube received within the saline-plasma valve housing 276. The control valves 286, 288 may fully clamp the tube (e.g., completely restrict fluid flow through the tube), but it should be understood that the control valves 286, 288 may also be partially actuated to a position that partially restricts fluid flow through a portion of the tube.

[0077] Referring now to FIG. 3A, a detailed perspective view of a disposable soft cassette assembly 300 according to an embodiment of the present disclosure is shown. 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 some embodiments, the cassette access door 304 is unlocked by actuating the cassette access door latch 308 and pivoted about the cassette access door hinge axis 306. The soft cassette assembly 300 may be configured with one or more soft cassette receiving features 324 for at least partially housing and / or positioning the soft cassette 340 therein. The soft cassette 340 may be part of a blood component collection set described herein. For example, the soft cassette 340 may be disposed between the cassette inlet tube 108A and the loop inlet tube 108B of an extracorporeal tubing circuit. In some embodiments, the soft cassette 340 includes one or more features for controlling the flow of blood and / or blood components from the donor 102 to the apheresis system 200 and / or vice versa.

[0078] 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 flow direction of fluid through the soft cassette 340. In some embodiments, these components may be embedded in a cassette access door 304, a base plate, and / or a portion of the housing 204 of the apheresis system 200. Similar to the guard closing function 254 described in connection with FIGS. 2B - 2C, the soft cassette assembly 300 may include one or more door closing functions 328. Examples of these functions 328 can include, but are not limited to, magnetic catches, protrusions, tabs and slots, and / or other connections. In one embodiment, the door closing function 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.

[0079] Examples of valves 320A to 320C include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamp valves, tube valves, and / or other operable valves configured to selectively change (e.g., block) a fluid passage (e.g., cross-sectional area, etc.) associated with a particular portion of the soft cassette 340. The soft cassette assembly 300 includes a first fluid control valve 320A configured to clamp a portion of the soft cassette 340 adjacent to the cassette inlet tube 108A. The second fluid control valve 320B may be configured to clamp a portion of the soft cassette 340 adjacent to the loop inlet tube 108B. The retraction fluid control valve 320C may be configured to clamp 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 configured to move from a retracted position or a partially retracted position to an extended position or a partially extended position to clamp a portion of the soft cassette 340 received within the soft cassette assembly 300. Valves 320A to 320C may completely clamp 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.

[0080] Sensors 312 and 316 may be one or more of ultrasonic detectors, pressure sensors, magnetic position sensors, and / or the like. The fluid sensor 316 may determine whether there is fluid in the soft cassette 340 based on the position of a 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 disposed 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 a 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 detection results of air or fluid by the air detection sensor 312 and the fluid sensor 316 may be used to signal the operating steps and / or to cause the steps of the control method described herein.

[0081] Figures 3B - 3D show various views of the soft cassette 340 according to an embodiment of the present disclosure. As described above, 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 the blood separation method described herein. In some embodiments, the soft cassette 340 may be formed from a substantially flexible and / or pliable material. The flexible material may be chemically inert and / or may be able to withstand sterilization and washing operations, temperature, and / or processing. The soft cassette 340 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicon, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In some embodiments, the soft cassette 340 is formed, molded, rotomolded, cast, injection molded, or otherwise formed from one or more of the foregoing materials.

[0082] 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 some embodiments, the first and / or second cassette ports 360A, 360B may be configured to receive and / or be in fluid communication with one or more tubes of a blood component collection set. For example, the first cassette port 360A is coupled to the cassette inlet tube 108A, and the second cassette port 360B is coupled to the loop inlet tube 108B. These couplings are airtight and / or fluidtight. In one embodiment, the first and / or second cassette ports 360A, 360B may include an opening disposed within the soft cassette 340 configured to elastically expand around the end of a tube (e.g., cassette inlet tube 108A, loop inlet tube 108B, etc.).

[0083] Blood supplied by the donor 102 is directed along one or more flow paths disposed within the soft cassette 340. In one embodiment, the blood is directed along the DC lumen 370 from the first cassette port 360A to the second cassette port 360B. In some embodiments, this flow path directs the blood through the drip chamber 354 of the soft cassette 340. In some embodiments, blood and / or other fluid returned to the donor 102 is directed along the DC lumen 370 from the second cassette port 360B to the first cassette port 360A.

[0084] The soft cassette 340 includes a fluid flow bypass path provided by a first bypass branch portion 358A having a bypass flow lumen 364 fluidly connected to a portion of the DC lumen 370 adjacent to or as part of the first cassette port 360A. In some embodiments, the bypass flow lumen 364 extends from a point on the DC lumen 370 adjacent to the first cassette port 360A, along the first bypass branch portion 358A, through the fluid pressure ring 362 to the second bypass branch portion 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.

[0085] Controlling the flow path within the soft cassette 340 or guiding the fluid involves operating the fluid control valves 320A - 320C of the soft cassette assembly 300 to interact the valves with various flexible regions 350A - 350C to block and / or open multiple portions of the direct current lumen 370 and / or the bypass flow lumen 364. The first flexible region 350A provides a pinch valve region at a point along the direct current 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 actuated, the valve 320A constricts the direct current lumen 370 in this first flexible region 350A, thereby restricting or completely blocking the fluid flow at this point within the soft cassette 340. The second flexible region 350B provides a pinch valve region at a point along the direct current lumen 370 between the second cassette port 360B near the second cassette end 346 (e.g., the end opposite the first cassette end 342) and the drip chamber 354. When the second fluid control valve 320B is actuated, the valve 320B constricts the direct current lumen 370 in this second flexible region 350B, thereby restricting or completely blocking the fluid flow at this point within the soft cassette 340. As can be understood, the third flexible region 350C disposed along the first bypass branch 358A adjacent to the fluid pressure ring 362 can provide a pinch valve region at a point along the bypass flow lumen 364. When the draw-in fluid control valve 320C is actuated, the valve 320C can constrict the bypass flow lumen 364 in this third flexible region 350C, thereby restricting or completely blocking the fluid flow through the bypass flow lumen 364.

[0086] As shown in the elevation cross - sectional view of FIG. 3C taken along a plane extending through the direct current lumen 370 and the drip chamber 354, the direct current 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 direct current 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.

[0087] In some embodiments, the bypass path of the soft cassette 340 includes a fluid pressure loop 362. Fluid can flow through this fluid pressure loop 362 from the first bypass branch 358A to the second bypass branch 358B and / or vice versa. In one embodiment, a pressure diaphragm 380 may be formed in the material of the soft cassette 340 within or adjacent to the fluid pressure loop 362. The fluid pressure loop 362 and the pressure diaphragm 380 are shown in a front elevation cross-sectional view of FIG. 3D taken along a plane extending through the fluid pressure loop 362 and a portion of the first and second bypass branches 358A, 358B. The pressure diaphragm 380 may provide a contact surface or a measurement surface for the fluid sensor 316 to detect whether the fluid pressure loop 362 and / or the bypass flow lumen 364 contains a predetermined amount of fluid, air, and / or a combination thereof. As described above, when the fluid fills a portion of the fluid pressure loop 362, the fluid can provide a greater resistance to movement than when the fluid pressure loop 362 is filled with air. This difference in resistance is measured by the fluid sensor 316, thereby determining the amount and type of fluid (e.g., air, blood, etc.) within the bypass flow lumen 364 and / or within the fluid pressure loop 362.

[0088] FIG. 4A shows a perspective view of a centrifuge assembly 400 of an apheresis system 200 according to an embodiment of the present disclosure. The centrifuge assembly 400 may be disposed within the internal space of the apheresis system 200. The internal space may be at least partially surrounded 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 disposed at the front portion 202 of the apheresis system 200. For example, the access panel 224 of FIG. 4A is shown in an open position opened along a hinge axis 226. As described above, the hinge axis 226 may correspond to a door hinge, a continuous hinge, a cleanroom hinge, and / or any other panel hinge.

[0089] The centrifuge assembly 400 is operably mounted inside the apheresis system 200 such that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the apheresis system 200. The centrifuge assembly 400 routes tubes (e.g., loop inlet tube 108B and loop outlet tube 112, etc.) into the internal space of the apheresis system 200 (e.g., via the opening 220 shown in FIG. 2A), connects a portion of the blood component collection loop 520 to the fixed loop connection 402, and inserts the blood component collection bladder 536 into the filler 460, thereby loading one or more portions of the blood component collection set. The fixed loop connection 402 maintains the loop inlet tube 108B and the loop outlet tube 112 in a fixed position and can prevent the twisting of the tubes 108B, 112 outside the apheresis system 200. In some embodiments, the blood component collection loop 520 may be interconnected to the fixed loop connection 402 via one or more keyed features or positive location features.

[0090] FIGS. 4B - 4C show various perspective views of the centrifuge assembly 400 separated from the apheresis system 200 for clarity of explanation. The centrifuge assembly 400 includes a centrifuge split housing 404 having a lower housing 404A rotatably connected to an upper housing 404B. The upper housing 404B can be opened to provide access for loading a blood component collection bladder or other components of the blood component collection set into the centrifuge assembly 400. In some embodiments, the upper housing 404B rotates about a split housing rotation axis 406 (configured, for example, as a hinge, pin, fastener, shoulder bolt, etc.).

[0091] The different halves 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 with respect to each other. Unlocking the upper housing 404B with respect to the lower housing 404A allows access to the interior of the centrifuge assembly 400. This selective locking may be performed by rotating the upper housing 404B with respect to the lower housing 404A about the centrifuge rotation axis 430. In FIGS. 4B - 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 about the centrifuge rotation axis 430 (e.g., in a counterclockwise direction) to engage one or more locking tabs 428 or elements of the upper housing 404B with a locking slot 432 disposed in the lower housing 404A (as shown in FIG. 4C). The upper housing 404B is opened or rotated about the split housing pivot axis 406 to load the blood component collection loop 520 and / or the blood component collection bladder 536 into the centrifuge assembly 400 when in the unlocked position. The upper housing 404B is rotationally locked with respect to the lower housing 404A when in the locked position, and the two halves of the centrifuge split housing 404 are locked together and rotate integrally during the centrifugation operation or the blood separation operation.

[0092] 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 some embodiments, 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 attached to or formed on 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 prevent over-rotation of the upper housing 404B with respect to the lower housing 404A. For example, when rotating the upper housing 404B clockwise or in the unlocking direction about 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 rotating the upper housing 404B counterclockwise or in the locking direction about 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 some embodiments, the centrifuge split housing 404 includes one or more locking elements. The locking elements are configured to maintain the halves of the centrifuge split housing 404 in a locked state while these locking elements are engaged.

[0093] In one embodiment, the centrifuge split housing 404 includes a pull ring 412 attached to a portion of the upper housing 404B for rotating the upper housing 404B relative to the lower housing 404A about the 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 that is unlocked in the rotational direction.

[0094] 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, a processor, and / or a power source. This electrical cable 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 a part of an electric motor that rotates the entire centrifuge assembly 400 relative to the apheresis system 200 (e.g., relative to a part 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 inside the apheresis system 200 (e.g., together the two halves of the centrifuge split housing 404).

[0095] As described herein, the centrifuge assembly 400 may include one or more features for guiding, housing, and / or positioning elements of a blood component collection set relative to the centrifuge split housing 404. For example, FIG. 4B shows the blood component collection loop 520 captured in an operating position within a loop rotation positioning guide 424 with 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 inner rotating component of the centrifuge assembly 400). As the centrifuge assembly 400 rotates during a centrifugation operation, the twisting of the blood component collection loop 520 between the fixed loop connection 402 and the connection at the filler 460 causes the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In one embodiment, the low inertia of the filler 460 combined 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 of rotation as the centrifuge split housing 404 at an angular velocity that is twice the angular velocity of the centrifuge split housing 404. In this example, if the centrifuge split housing 404 rotates counterclockwise about the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 rotates counterclockwise within the centrifuge split housing 404 at a second angular velocity 2ω (e.g., approximately twice the first angular velocity).

[0096] The centrifuge assembly 400 may include one or more balancing features, elements, and / or structures disposed about the centrifuge rotation axis 430 of the centrifuge assembly 400. These balancing features can provide an axially balanced centrifuge assembly 400 that does not substantially impart vibration to the apheresis system 200 when rotating the centrifuge assembly 400 about the centrifuge rotation axis 430. In one embodiment, the centrifuge balance weight 418 is attached to a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). The centrifuge balance weight 418 can be custom adjusted for the centrifuge assembly 400 and thus can be selectively attached and removed relative to the centrifuge assembly 400. The adjustment of the centrifuge balance weight 418 is calculated and / or experimentally derived to provide a fully balanced centrifuge assembly 400, particularly when one or more elements of the blood component collection set are loaded.

[0097] FIG. 4C shows a rear perspective view of a centrifuge assembly 400 according to an embodiment of the present disclosure. A portion of the filler 460 is visible through the opening of the upper housing 404B. The blood component collection loop 520 is shown in an initial loop loading position 520A, in which the first end is interconnected with the filler 460 and the second end is attached and fixed to a fixed loop connection 402 (not shown). The blood component collection loop 520 is shown passing through a loop access clearance 436 of the centrifuge split housing 404. When the blood component collection loop 520 is loaded into the loop loading position 520A, a portion of the blood component collection loop 520 is partially received, held, and / or supported by a loop storage bracket 426. The loop storage bracket 426 includes one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc., and / or assemblies thereof, etc.) or bearing surfaces arranged to at least partially support the blood component collection loop 520 when the blood component collection loop 520 is twisted relative to the centrifuge assembly 400. In some embodiments, the blood component collection loop 520 rotates about an axis extending along the length of the flexible loop 524 (e.g., in an installed or mounted situation and / or state, etc.) to enable relative rotational movement of the flexible loop 524 with respect to a loop rotation positioning guide 424. For example, the loop does not "twist up" and actually rotates or rolls relative to the loop rotation positioning guide 424 (e.g., a support structure) between one or more bearings 417. This rotation or torsion without winding or twisting the flexible loop 524 may be referred to herein as "twist". Due to this twist, the flexible loop 524 can transmit a rotational force to the filler 460 without substantially 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.

[0098] As described above, when the upper housing 404B is rotated from the unlock position in the rotational direction shown in FIGS. 4B - 4C to the lock 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 or alternatively, when moved to the lock position in the rotational direction, the loop storage bracket 426 rotates to a position aligned with the loop rotation positioning guide 424 along the loop engagement position 520B, together with the blood component collection loop 520 and the upper housing 404B. In some embodiments, when 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 loading of the blood component collection loop 520 will be described in connection with FIGS. 6A - 7B.

[0099] FIGS. 4D - 4F show various schematic cross - sectional views through the center of the centrifuge assembly 400 (e.g., bisecting the centrifuge assembly 400 by the centrifuge rotation axis 430, etc.). As described above, the centrifuge assembly 400 includes a lower housing 404A rotatably attached to the upper housing 404B by a split housing pivot axis 406 or hinge. The upper housing 404B is attached to an upper housing adapter 440 rotatably connected to an upper housing bushing block 442 attached to the pull ring 412. In one embodiment, a bearing 417, bushing, or bearing surface may be disposed 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 the lock position to the unlock position and vice versa. The pull ring 412 may be fixed relative to the lower housing 404A in the rotational direction about the centrifuge rotation axis 430. In some embodiments, the upper housing adapter 440 and the upper housing 404B may be formed from an integral structure.

[0100] The filler 460 is attached and fixed to a filler mandrel 434 configured to rotate with respect to the upper housing 404B about the centrifuge rotation axis 430. In one embodiment, the filler mandrel 434 is formed from a portion of the filler 460. In any case, one or more mandrel support bearings 444 are disposed between the filler mandrel 434 and the upper housing adapter 440 so that the filler 460 can rotate about the centrifuge rotation axis 430 inside the centrifuge split housing 404 and the centrifuge assembly 400. In some embodiments, the filler mandrel 434 is held in the operating position by at least one retaining nut 438. The filler 460 and the filler mandrel 434 can rotate integrally with respect to the centrifuge split housing 404.

[0101] FIG. 4D shows a schematic cross-sectional view of a closed centrifuge assembly 400 according to an embodiment of the present disclosure, for example, before loading the blood component collection loop 520. When unlocking the upper housing 404B with respect to the lower housing 404A, the operator pulls the pull ring 412 to rotate the entire upper housing 404B and the filler 460 about the split housing rotation axis 406. In one embodiment, the upper housing 404B and the filler 460 are partially opened by rotating the components in the opening direction 446 about the split housing rotation axis 406 as shown in FIG. 4E. As shown in FIG. 4E showing the centrifuge assembly 400 in a partially opened state, the upper housing 404B and the filler 460 are rotated so as to be axially spaced from the lower housing rotation axis 430A. In this position, the filler 460 may be enabled to rotate about the filler rotation axis 430B. When the lower housing 404A and the upper housing 404B are in the closed state, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (coincide or substantially coincide) so as to form the centrifuge rotation axis 430.

[0102] Continuing to rotate the upper housing 404B and the filler 460 in the opening direction 446 (e.g., by continuing to pull the pull ring 412) about the Y-axis of the split housing rotation axis 406, the upper housing 404B and the filler 460 can rotate approximately 180° from the closed position shown in FIG. 4D. As shown in FIG. 4F, the centrifuge assembly 400 is in an open or mounted state. In this position, the upper housing 404B and the filler 460 can rotate outside the internal space of the apheresis system 200. For example, at least a portion of the upper housing 404B and / or the filler 460 is positioned and arranged through the open space of the open access panel 224. In this position, a loading access area 450 is provided for the loop connection area 454 of the filler 460. As can be understood, when the upper housing 404B is in the open position, easy access to the interior of the upper housing 404B and the filler 460 is available. In particular, this arrangement can provide sufficient space for an operator to attach the blood component collection loop 520 to the filler 460 at the loop connection area 454.

[0103] Referring to FIG. 4G, a perspective view of the filler 460 for the centrifuge assembly 400 according to an embodiment of the present disclosure is shown. In some embodiments, the filler 460 is formed from a lightweight material such as, for example, plastic, carbon fiber, aluminum. In one 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 forms of the filler 460 that may not be possible with the use of conventional machining or manufacturing processes. In some embodiments, 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.

[0104] The filler 460 includes a loop connection region 454 disposed at approximately the center of the filler 460. The loop connection region 454 includes one or more keying features or positive positioning features for engaging a portion of the blood component collection loop 520. As shown in FIG. 4G, the loop connection region 454 includes a first positive positioning feature 478 disposed along a portion of the central axis of the filler 460. The first positive positioning feature 478 may be a keyway, groove, slot, or other feature for engaging a mating feature disposed on the blood component collection loop 520. In some embodiments, the filler 460 has a second positive positioning feature 480 in the loop connection region 454. The positioning features 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 disengaging from the loop connection region 454 of the filler 460.

[0105] In some embodiments, the filler 460 includes a collection insertion channel 466 configured to receive and at least partially house the blood component collection bladder of the blood component collection set, and more specifically, the blood component collection loop 520. The collection insertion channel 466 is configured as a groove or slot that extends outwardly in a substantially helical shape from the center of the filler 460. In some embodiments, the collection insertion channel 466 follows a substantially helical path that includes a first helical path portion that extends outwardly along the length of the outer perimeter of the collection insertion channel 466 from the center of the filler 460 (e.g., relative to the center of the filler 460) to a substantially constant radius. In any case, the path is referred to herein as a helical path or a substantially helical path. The collection insertion channel 466 begins at a channel inlet 468 near the center of the filler body 464 and ends at a channel end 472 near the point furthest from the center of the filler body 464. As shown in FIGS. 4G-4I, the collection insertion channel 466 extends along a substantially helical path 490 that extends from a point near the filler rotation axis 430B to the channel end 472. The substantially helical path 490 includes a channel path jog 476 at a point near or adjacent to the channel end 472. This channel path jog 476 increases the separation distance of the collection insertion channel 466 from the center of the filler body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the collection insertion channel 466. In one embodiment, this channel path jog 476 corresponds to a critical inlet / outlet port at the maximum radial position within the blood component collection bladder 536 that is at least partially inserted or disposed within the collection insertion channel 466 of the filler 460. In some embodiments, the filler 460 may include one or more filler balance protrusions 482 disposed on or near a portion of the filler body 464. These filler balance protrusions 482 can provide an axially balanced filler 460 (e.g., balanced about the filler rotation axis 430B), particularly when the collection insertion channel 466 contains a blood component collection bladder and a fluid (e.g., blood, blood components, etc.).

[0106] FIG. 4I is a schematic plan view of a substantially helical receiving channel or collection insertion channel 466 in a filler 460 according to an embodiment of the present disclosure. This schematic plan view shows a first distance R1 of the collection insertion channel 466 from the center of the filler body 464 at a first point along the substantially helical path 490 (e.g., in the vicinity of the filler rotation axis 430B, etc.), and a second distance R2 of the collection insertion channel 466 from the center of the filler body 464 past a point near the channel path jog 476. As shown in FIG. 4I, the second distance R2 is farther from the center of the filler body 464 than the first distance R1. This increment in distance can impart a higher centripetal or centrifugal force to the channel at a point at or near the channel end 472 than at any other point along the substantially helical path 490. In some embodiments, the end of the blood component collection bladder substantially coincides with the channel end 472, thereby providing the greatest blood separation force at the end of the bladder.

[0107] Figures 4J - 4L show various elevation cross - sectional views of the filler 460, and more specifically, the collection insertion channel 466 and the filler insertion chamber 492 disposed inside the filler body 464. In some embodiments, the collection insertion channel 466 includes a cross - section or shape that generally follows a substantially helical path 490 within the filler body 464. The collection insertion channel 466 includes an insertion groove configured to receive a substantially flat or unfilled blood component collection bladder. The blood component collection bladder is inserted into the collection insertion channel 466 and into the filler insertion chamber 492 formed within the filler body 464 along the substantially helical path 490. The filler insertion chamber 492 is defined by one or more side walls 494, 496 that form a cavity following the substantially helical path 490. As shown in Figure 4K, the filler insertion chamber 492 includes an inner chamber wall 494 spaced a given distance from at least one outer chamber wall 496. The filler insertion chamber 492 may be formed in the filler 460 by 3D printing the filler 460 and / or by any one or more other metal or plastic forming processes (e.g., casting, molding, shaping, etc.). In some embodiments, the filler insertion chamber 492 includes one or more insertion guide features 498. These insertion guide features 498 are configured to guide, position, and / or seat a blood component collection bladder inside the filler insertion chamber 492 of the filler 460. The insertion guide features 498 are shown as chamfered or recessed features of the filler insertion chamber 492, but may include one or more radii, chamfers, slopes, tapers, draft angles, receptacles, grooves, and / or other shaped materials configured to direct and / or orient a portion of the inserted blood component collection bladder.

[0108] FIG. 4L shows different states of a fluid collection bladder (e.g., a blood component collection bladder, etc.) disposed within a filler collection insertion channel 466 and a filler insertion chamber 492 of a filler 460. As described above, the blood component collection bladder is inserted into the collection insertion channel 466 in a substantially flat, i.e., unfilled state S1. In the substantially flat state S1, the blood component collection bladder is dimensioned to enter the upper opening of the collection insertion channel 466 and be maintained in a pre-filling state within the filler insertion chamber 492. When the filler 460 rotates and begins to separate blood components from the blood supplied by the donor 102, the blood component collection bladder expands from the substantially flat first state S1 to an expanded, i.e., filled state S2. In some embodiments, the blood component collection bladder may be expanded by blood and / or blood components until the walls of the blood component collection bladder contact the walls 494, 496 of the filler insertion chamber 492. In one embodiment, the shape of the filler insertion chamber 492 is designed to optimize the amount of fluid that can be collected and / or separated within the filler insertion chamber 492 (e.g., maximizing the amount of fluid while minimizing the amount of material for the filler 460).

[0109] FIG. 5A shows a schematic view of a blood component collection set 500 according to an embodiment of the present disclosure. The blood component collection set 500 includes one or more of tubes (e.g., a donor supply tube 104, a cassette inlet tube 108A, a loop inlet tube 108B, an anticoagulant tube 110, a loop outlet tube 112, a saline tube 116, a plasma tube 120, etc.), connectors (e.g., a tube connector 106, a saline / plasma tube y-connector 280, a tube fixture 504, a tube fixture 508, a bag spike fixture, etc.), a soft cassette 340, and a blood component collection loop 520.

[0110] The tube is any tube having a central lumen configured to convey a 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 (e.g., at one or more ends of the tube, etc.). The connector may be inserted into the central lumen of the tube and / or attached to the outer surface of the tube. In some embodiments, the connector is configured with various fittings (e.g., luer fittings, twist connections, and / or other small bore couplings, etc.) to provide a universal and / or reliable interconnection to one or more other fixtures, connectors, tubes, needles, and / or medical accessories. In one embodiment, the bag spike fitting 512 may be configured to be inserted into a receiving bag (e.g., a saline bag 118, etc.).

[0111] The blood component collection loop 520 includes a flexible loop 524 disposed between a system fixed loop connector 528 and a filler loop connector 532. The flexible loop 524 may be configured as a hollow flexible tube configured to receive and / or contain at least a portion of the loop inlet tube 108B and the loop outlet tube 112. In some embodiments, the flexible loop 524 may be formed from a thermoplastic elastomer having a high flexibility capable of transmitting a twist from one end of the flexible loop 524 to the other end. These types of elastomers can provide the flexibility of rubber while maintaining the strength and torque characteristics of plastic. Examples of thermoplastic elastomers include, but are not limited to, copolyesters, DuPont (trademark) Hytrel (registered trademark) thermoplastic elastomers, Eastman Neostar (trademark) elastomers, Celanese Riteflex (registered trademark) elastomers, TOYOBO PELPRENE (registered trademark), and / or other brands of elastomers providing high flexibility and strength characteristics.

[0112] In some embodiments, the blood component collection loop 520 includes a blood component collection bladder 536 having a bladder loop end 540A and a bladder free end 540B. The blood component collection bladder 536 includes a first collection flow chamber 544 connected to the flexible loop 524 by a fill 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 in a direction from the bladder loop end 540A along the first collection flow chamber 544 towards the bladder free end 540B can reach a flow chamber transition 548 and enter a second collection flow chamber 552. In one embodiment, the second collection flow chamber 552 is interconnected to the flexible loop 524 by a fill loop connector 532. In particular, 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.

[0113] Details of the blood component collection loop 520 are described in connection with the elevation view of FIG. 5B. The blood component collection loop 520 includes a flexible loop 524 configured as a tube including a first path for the loop inlet tube 108B and a second path for the loop outlet tube 112. In some embodiments, the loop inlet tube 108B passes through the flexible loop 524 and interconnects with the first collection flow chamber 544 at the bladder loop end 540A via a fill loop connector 532. In addition or alternatively, 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 fill loop connector 532. The first path is separate from the second path. With this configuration, blood can enter the flexible loop 524 and the blood component collection bladder 536 via the first collection flow chamber 544 and be separated into one or more blood components. The blood components are then conveyed along the second collection flow chamber 552 to the loop outlet tube 112 within the flexible loop 524.

[0114] 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 collection bladder 536. For example, the blood component collection bladder 536 may be formed from layers of material that overlap each other along the length of the blood component collection bladder 536. The layers of material may be formed (e.g., cut or shaped, etc.) and heat-sealed along one or more edges that form a fluid container. The flow chamber separator 542 may be formed within the fluid container by heat-sealing one layer of material to another layer of material substantially along the illustrated path. The flow chamber separator 542 does not extend across the entire length of the blood component collection bladder 536, but provides a flow chamber transition portion 548 for fluid (e.g., blood, blood components, etc.) to pass from the first collection flow chamber 544 to the second collection flow chamber 552 and / or vice versa. In one embodiment, the fluid (blood and / or blood components, etc.) within the blood component collection bladder 536 that is received within the filler insertion chamber 492 of the filler 460 flows around the end of the flow chamber separator 542 (e.g., following the blood component movement direction 546) in a direction towards the bladder free end 540B along the first collection flow chamber 544 and can move into the second collection flow chamber 552. In this example, the blood component (e.g., plasma, etc.) may be pushed back along a substantially helical path 490 through the loop outlet tube 112 along the second collection flow chamber 552 and towards the center of the filler body 464 (e.g., towards the plasma collection bottle 122).

[0115] The blood component collection bladder 536 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), thermoplastic substances, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In some embodiments, the blood component collection bladder 536 may be formed from multiple material layers and heat-sealed, formed from a single material layer folded over itself, and / or combinations thereof.

[0116] In some embodiments, the blood component collection loop 520 may include a number of positive positioning features or key features 530A, 530B configured to positively position multiple locations of the blood component collection loop 520 relative to the apheresis system 200 and / or the filler 460. For example, the blood component collection loop 520 may include a first connector positioning feature 530A on the system fixed loop connector 528 and a second connector positioning feature 530B on the filler loop connector 532. The features 530A, 530B may be configured as keys, tabs, and / or other protrusions of material extending from the connectors 528, 532. In some embodiments, the second connector positioning feature 530B may include features that interconnect or mate with a first positive positioning feature 478 and / or a second positive positioning feature 480 of the loop connection region 454 of the filler 460. Similar positive positioning features may be associated with or included in the fixed loop connection 402 of the apheresis system 200, if not identical.

[0117] Figures 5C and 5D show cross-sections of the blood component collection bladder 536 of the blood component collection loop 520 according to embodiments of the present disclosure. 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 collection bladder 536. In some embodiments, this separation may be provided by a flow chamber separator 542 disposed between the first collection flow chamber 544 and the second collection flow chamber 552. The flow chamber separator 542 may correspond to a sealed region of the blood component collection bladder 536. The flow chamber separator 542 may be formed, for example, as a heat-sealed region of a material that joins the bladder first side material 536A and the bladder second side material 536B. In some cases, the bladder first side material 536A and the bladder second side material 536B may be a single material member that is folded at an edge (e.g., adjacent to one of the upper bladder seal 554A region or the lower bladder seal 554B region).

[0118] The cross-section shown in FIG. 5D may correspond to the blood component collection bladder 536 before sealing, and the cross-section shown in FIG. 5C may correspond to the blood component collection bladder 536 after the upper bladder seal 554A, the lower bladder seal 554B, and / or the flow chamber separator 542 are formed or sealed (e.g., by welding the bladder first side material 536A to the bladder second side material 536B, etc.). When formed, the width WB of the bladder may correspond to the width of the first collection flow chamber 544 and / or the second collection flow chamber 552 in the non-expanded state S1 (see, e.g., FIG. 4L). During operation, when fluid fills at least a portion of the blood component collection bladder 536, the dimension of the width WB of the bladder may increase from the dimension shown in FIG. 5C. For example, the width WB of the bladder may increase substantially to the size of the filler insertion chamber 492 of the filler 460. In some embodiments, the welds (e.g., RF, ultrasonic, etc.) formed when manufacturing the blood component collection bladder 536 may be supported by the filler 460. In one embodiment, the upper end of the filler 460 supports the upper two welds, and the lower end of the filler 460 supports the lower weld.

[0119] Figures 5E-5H show various perspective views of the bent state of the blood component collection loop 520 (e.g., FIGS. 5E-5F), and views of the bent blood component collection bladder 536 of the blood component collection loop 520 inserted into the filler 460 (e.g., FIGS. 5G-5H). The various components of the blood component collection loop 520 may be flexible and / or may be formed or shaped by the application of force. In some embodiments, this flexibility may be an elasticity such that the formation of the various portions of the blood component collection loop 520 does not permanently deform the components. FIG. 5E shows the blood component collection loop 520 in a bent state according to an embodiment of the present disclosure. For example, the flexible loop 524 is shown elastically bent along its length, and the blood component collection bladder 536 is shown along its length following a number of bent or curved portions. The flexible loop 524 still conveys fluid supplied via the loop inlet tube 108B to the first collection flow chamber 544 of the blood component collection bladder 536 while the components are in the bent state, and vice versa. In addition to or instead of this, the flexible loop 524 may convey fluid from the second collection flow chamber 552 of the blood component collection bladder 536 to the loop outlet tube 112 while the components are in the bent state, and vice versa.

[0120] In some embodiments, the blood component collection loop 520 may be preformed to fit within the collection insertion channel 466 of the filler 460, as shown in the perspective view of FIG. 5F. This preforming may include bending the blood component collection bladder 536 of the blood component collection loop 520 to conform to the generally helical path 490 of the collection insertion channel 466. At the time of preforming, the functional portions of the blood component collection loop 520 may be aligned with one or more functional portions of the filler 460, as shown in FIG. 5G. In one 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 the second connector positioning feature 530B engages the first detent positioning feature 478. In addition or alternatively, the blood component collection bladder 536 may be formed or shaped (e.g., by hand, etc.) to conform to the generally helical path 490 of the collection insertion channel 466 in the filler 460. In some cases, this forming or shaping may include aligning the bladder free end 540B of the blood component collection bladder 536 with the channel end 472 of the collection insertion channel 466 in the filler 460. As the components are generally aligned with each other, the blood component collection loop 520 may be moved in the direction towards the collection insertion channel 466 and the loop connection region 454 (as shown in FIG. 5G).

[0121] In some embodiments, as the filler loop connector 532 is moved into the loop connection region 454 of the filler 460, the first detent positioning feature 478 interconnects with and / or holds the second connector positioning feature 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. FIG. 5H shows a perspective view of the blood component collection loop 520 loaded within the filler 460 according to an embodiment of the present disclosure.

[0122] Figures 6A - 6C show schematic cross - sectional views of the centrifuge assembly 400 in various loop - mounted states according to embodiments of the present disclosure. The centrifuge assembly 400 shown in Figures 6A - 6C corresponds to the centrifuge assembly 400 described above, particularly in relation to Figures 4D - 4F. In particular, Figure 6A shows a schematic cross - sectional view of a first loop - mounted state, Figure 6B shows a schematic cross - sectional view of a second loop - mounted state, and Figure 6C shows a schematic cross - sectional view of a second loop - mounted state for the centrifuge assembly 400.

[0123] In Figure 6A, the centrifuge assembly 400 is shown in an open - loop - mounted position where the upper housing 404B is rotated 180 degrees from the closed or operating position. This open position may correspond to the position of the centrifuge assembly 400 shown in 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 to 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 portion 402 via the system - fixed loop connector 528. In this first loop - mounted state, the flexible loop 524 is fixed to the fixed - loop connection portion 402 so as not to rotate, but rotates integrally with the filler 460 at the loop - connection region 454.

[0124] In Figure 6B, the centrifuge assembly 400 is shown in a partially - closed position where the upper housing 404B is in a state of moving from the open position to the closed or 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 portion 402, but the filler 460 can rotate freely about the filler rotation axis 430B (e.g., limited only by the flexible loop 524 fixed in the rotational direction).

[0125] In FIG. 6C, the centrifuge assembly 400 is shown in a closed or operating position where the upper housing 404B can be locked to the lower housing 404A (such that the lower housing 404A and the upper housing 404B can rotate integrally about the centrifuge axis of rotation 430). In this position, the flexible loop 524 extends from the loop connection region 454 of the filler 460 through the loop access clearance 436 of the centrifuge split housing 404 to the fixed loop connection 402. In some embodiments, the flexible loop 524 can move freely within the loop access clearance 436 in contact with or without contacting one or more portions of the centrifuge split housing 404. In this position, when the centrifuge assembly 400 rotates about the centrifuge axis of rotation 430, the flexible loop 524, which is fixed in the rotational direction at the fixed loop connection 402, can be twisted along the length of the flexible loop 524, thereby rotating the filler 460 within the centrifuge assembly 400 (e.g., along the centrifuge axis of rotation 430). As described above, the rotation of the filler 460 relative to the centrifuge assembly 400 may be in a 2:1 ratio. For example, when the centrifuge assembly 400 makes one full rotation, the flexible loop 524, which is fixed in the rotational direction (e.g., fixed at the fixed loop connection 402), is twisted at the loop connection region 454 (e.g., tries to unwind so as not to be twisted by the rotation of the centrifuge assembly 400), thereby rotating the filler 460 in the same rotational direction as the centrifuge assembly 400 but making approximately two full rotations. This rotation of the filler 460 due to the twist of the flexible loop 524 along its length does not require engagement between the centrifuge assembly 400 and the filler 460.

[0126] Figures 7A - 7B show schematic plan views of a centrifuge assembly 400 that automatically mounts a loop to an operating position for centrifugation (e.g., blood separation). The centrifuge assembly 400 shown in Figures 7A - 7B may correspond to the centrifuge assembly 400 described above and / or in connection with Figures 4A - 4F and 6A - 6C. When 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 - 7B.

[0127] In one embodiment, when the upper housing 404B is locked to the lower housing 404A, the flexible loop 524 extends from the loop connection region 454 of the filler 460 to the fixed loop connection portion 402 of the apheresis system 200. The flexible loop 524 may be rotationally fixed to the fixed loop connection portion 402 with a 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 initially be held or at least partially captured by the loop rotation positioning guide 424 and / or other features of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop rotation positioning guide 424 or loop arm corresponds to the uncaptured loop state 700A. In other words, the flexible loop 524 may be oriented at some angle α relative to the loop rotation positioning guide 424, the loop positioning stopper plate 704, and / or one or more loop twist support bearings 708, or bearing set. In some embodiments, the loop twist support bearing 708 may correspond to the bearing 417 described in connection with Figures 4B - 4C. A loop storage area or channel may be formed by one or more loop twist support bearings 708 disposed along the length of the loop positioning stopper plate 704 and / or the upper housing 404B. In some embodiments, this orientation may be designed to facilitate access and / or mounting during loop attachment as described in connection with Figures 6A - 6C.

[0128] When the centrifuge assembly 400 is rotated about the centrifuge axis 430 in the loop - filler rotation direction 712, the flexible loop 524 can move from the uncaptured loop state 700A to the captured loop state 700B shown in FIG. 7B. This rotation may be caused by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the loop - filler rotation direction 712 and / or by a rotor - motor assembly 414 rotating the centrifuge assembly 400 about the centrifuge axis 430. In some embodiments, when the flexible loop 524 rotates in the loop - filler rotation direction 712, the outer portion of the flexible loop 524 contacts the loop positioning stopper plate 704 or other rotational stopper surfaces of the loop rotation positioning guide 424.

[0129] With the flexible loop 524 held within or at least partially received 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 described above, the flexible loop 524 may be rotationally fixed to the fixed loop connection portion 402 via the first connector positioning feature 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 portion 402. The other end of the flexible loop 524 may be interconnected at the loop connection region 454 of the filler 460 where this end can move 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, forces that tend to unwind or wrap around the flexible loop 524 cause rotation of the filler 460 and the end of the flexible loop 524 attached to the filler.

[0130] In any case, when the fluid separation method described herein is completed, the rotation of the centrifuge assembly 400 is stopped and the disposable elements of the blood component collection set 500 are removed from the centrifuge assembly 400 by opening the centrifuge split housing 404. In some cases, the flexible loop 524 may be moved from the captured loop state 700B shown in FIG. 7B to the uncaptured loop state 700A shown in FIG. 7A by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the loop - filler rotation direction 712.

[0131] The functional diagram of the apheresis system 200 may be as shown in FIG. 8 according to an embodiment of the present disclosure. The description herein shows the components already described in FIGS. 1 - 7B in the functional diagram to represent the operation of the system 200 for extracting plasma or other blood components from the whole blood of the donor 102 during an apheresis procedure or process.

[0132] The system 200 can 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, the AC tube 110, and / or the AC bag 114 may be as described above. Also, the AC tube 110 may include an AC air detection sensor (ADS) 804 for detecting air or fluid within the AC tube 110. The AC ADS 804 may be the same as or similar to the sensors 284 and / or 312 whose type and / or function have already been described. The AC tube 110 is fluidly associated with the donor supply tube 104 and the cassette inlet tube 108A at the tube connector 106. The tube connector 106 may be any type of connection between the tubes 110, 104 and / or the tube 108A as already described.

[0133] The donor supply tube 104 proceeds from the donor 102, where in this case the donor 102 may be punctured with a lumen needle or other device, whereby whole blood can flow from the donor 102 into the apheresis system 200 and blood components can flow back to the donor 102. The tube 108A extends to the soft cassette 340. Further, a donor air detection sensor 312 can be disposed on or within the tube 108A to detect the presence of fluid and / or air within the tube 108A.

[0134] As previously described, the soft cassette 340 can include a "Y" connector or section or branch that can function as a "Y" connector or section or branch, and / or can include a first cassette port 360A that is in close proximity to the "Y" connector or section or branch, where the first cassette port 360A separates the tube 108A into a first bypass branch 358A and a first tube section 368A (the "Y" section being indicated by reference numeral 360A). The two tube sections 358, 368 can similarly include a second "Y" connector or section that can function as a second "Y" connector or section, and / or can be reconnected at a second cassette port 360B that is in close proximity to the second "Y" connector or section (the second "Y" section being indicated by reference numeral 360B). The tube 358 is split into two by a fluid sensor 316, which separates the tube 358 into a first bypass branch 358A and a second bypass branch 358B. Similarly, the tube 368 is split into two by a drip chamber 354, which separates the tube 368 into a first tube section 368A and a second tube section 368B.

[0135] The first tube section 368A can include the first fluid control valve 320A. Similarly, the second tube section 368B can include the second fluid control valve 320B. Similarly, the first bypass branch 358A can include the draw-in fluid control valve 320C. Thus, depending on the form of the system 200 and in response to the operation of the system 200, various sections of the tubes 368A, 358A, 358B, 368B can be separated by the valves 320A, 320B and / or the valve 320C.

[0136] The drip chamber 354 may be disposed between the first tube section 368A and the second tube section 368B. As will be described later, the drip chamber 354 can collect a predetermined amount of whole blood and / or high-hematocrit blood (blood with a high proportion of red blood cells) in response to the operation of the system 200. The fluid sensor 316 may be disposed between the first bypass branch 358A and the second bypass branch 358B as already described.

[0137] The loop inlet tube 108B can be connected to the second cassette port 360B and can connect the soft cassette 340 to the flexible loop 524. Also, the loop inlet tube 108B may include a sensor 808 disposed on or within the tube 108B and arranged 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, and / or optionally other characteristics of the fluid within the tube 108B, but is not limited thereto. Further, the draw-in pump 208 can pump fluid away from the soft cassette 340 or into the soft cassette 340 through the tube 108B.

[0138] Two or more different tubes can be connected to the flexible loop 524 via the system fixed loop connector 528, and the two or more different tubes can supply fluid to the blood component collection bladder 536 or receive fluid from the blood component collection bladder 536. The loop outlet tube 112 exits the system fixed loop connector 528 from the flexible loop 524. This loop outlet tube 112 can also include other line sensors 812 disposed on or within the loop outlet tube to detect fluid, air, intracellular concentration, color, and / or color change in the fluid coming from the flexible loop 524. The line sensor 812 may be the same as or similar to the sensors 804, 312, 320, 808 and / or sensor 284 whose type and / or function have already been described. A second CPS sensor 816 or fluid sensor may be disposed within or on the line 112. The sensor 816 may detect one or more of the presence or absence of fluid, pressure, and / or other characteristics of the fluid within the tube 112, but is not limited thereto. Similarly, the sensor 816 may be the same as or similar to the sensors 804, 312, 320, 808, 812 and / or sensor 284 whose type and / or function have already been described.

[0139] The loop outlet tube 112 may then flow into the plasma air detection sensor 284 before the physiological saline / plasma tube y-connector 280 separates the tube 112 into the physiological saline tube 116 and the plasma tube 120. A return pump 212 may interact with the loop outlet tube 112, and by this return pump, fluid or air can flow through the tube 112 from the flexible loop 524 or from the physiological saline bag 118 and / or the plasma collection bottle 122.

[0140] The saline bag 118 and associated tubing may already be as described, and saline can be supplied through the system 200 to the original donor 102. The saline flow control valve 288 can isolate the saline bag 118 from the rest of the system 200. Further, the plasma collection bottle 122 can receive plasma from the flexible loop 524 when the plasma 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.

[0141] An embodiment of an electrical and control system 900 that controls the functions of the apheresis system 200 may be as shown in FIG. 9 according to an embodiment of the present disclosure. The control system 900 can include one or more nodes, and the nodes can 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.

[0142] Each node may function to control different parts of the apheresis system 200. For example, the control system 900 can include a cassette node 904 and a centrifuge node 908 that can control or communicate with the components of the blood component collection set 500 (and associated hardware or mechanical components that interface with the soft cassette assembly 300) and the centrifuge assembly 400 (and associated hardware or mechanical components associated with the centrifuge assembly). The cassette node 904 and the centrifuge node 908 may communicate wirelessly or via some other electrical or data connection. In some forms, 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 that operates to control different functions. An example of the cassette node 904 can be described in connection with FIG. 10, and the centrifuge node 908 can be described in connection with FIG. 11.

[0143] Each of nodes 904 and 908 may communicate with one or more sensors 916, 920 and / or sensor 924. As represented by ellipsis 928, there may be more or fewer sensors than those shown in FIG. 9. Each node 904, 908 can communicate directly with each sensor 916 - 924, or may communicate with some of the sensors 916 - 924 via bus 912. Bus 912 may communicate by any type of communication protocol such as a Universal Serial Bus (USB), Universal Asynchronous Receiver / Transmitter (UART), or other type of bus system or parallel communication connection. Thus, bus 912 is shown as an optional but possible communication platform for communicating with various sensors 916 - 924. Sensors 916 - 924 may be any type of sensor capable of communicating information regarding light, fluid, presence of air, color, pressure, etc., as described herein. Some of 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.

[0144] Nodes 904, 908 may communicate with one or more pump drives, pump motors, etc. 936, 940, 944 simply referred to as "pumps". As represented by ellipsis 948, there may be more or fewer pumps than those shown in FIG. 9. Nodes 904, 908 can communicate with pumps 936 - 944 via direct wired or wireless communication or via bus 932. Bus 932 may be a Controller 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 may be as described in this specification.

[0145] One embodiment of the cassette node 904 may be as shown in FIG. 10 in accordance with an embodiment of the present disclosure. The cassette node 904 can include a controller 1004, a memory 1008, a valve controller 1020, and / or one or more of communication interfaces for a CAN bus 1016, a UART 1012, or other types of buses. The cassette node 904 can include other hardware, firmware, and / or software not shown for clarity.

[0146] 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 or direct the functions of other types of devices, such as, for example, valves 320A, 320B, 320C, 286, 288, pumps 936-944, etc. Further, the controller 1004 can communicate with various sensors 916-924 or other devices to receive or send information regarding the functions of the apheresis system 200.

[0147] Other examples of a processor or microcontroller 1004 as described herein may include, but are not limited to, 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, Intel® Core™ i5-3570K 22nm 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™ processors, and may include at least one of other industry equivalent processors, and may perform computer functions using any known or future developed standard instruction set, library, and / or architecture.

[0148] Memory 1008 may be any type of memory including random access memory (RAM), read only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disc read only memory (CD-ROM), optical storage devices, magnetic storage devices, any suitable combination of the above, or other types of storage devices or memory devices that store and provide instructions for programming and controlling controller 1004. As will be described later, memory 1008 may provide all types of software or firmware for programming the functions of controller 1004.

[0149] Controller 1004 can communicate with one or more valve controllers 1020. Each valve 320A, 320B, 320C, 286, 288 described herein may be controlled by valve controller 1020 and associated with the components of system 200 as described herein. Valve controller 1020 can supply an electrical signal, an operating command, or power to close or open any one of the valves described herein, for example, saline / plasma valve housing 276, plasma flow control valve 286, first fluid control valve 320A, first fluid control valve 320A, and / or draw fluid control valve 320C, etc.

[0150] Controller 1004 can also be connected to buses 912, 932 (e.g., UART bus, CAN bus) or other buses via transceivers 1012, 1016 provided outside controller 1004 or integrated with controller 1004. UART transceiver 1012 may communicate with one or more of sensors 916 - 924 or other devices. Similarly, CAN bus transceiver 1016 can communicate with one or more of pump controllers 936 - 944 or other devices. UART transceiver 1012 and bus and CAN bus transceiver 1016 and bus are well known in the art and need not be further described herein.

[0151] An embodiment of the centrifuge node 908 can be shown in FIG. 11 according to an embodiment of the present disclosure. The centrifuge node 908 can include components of the same or similar type as the cassette node 904. For example, the centrifuge node 908 can include a controller 1104, a UART transceiver 1112, etc. Similar to the controller 1004, the controller 1104 can 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, etc., which can be the devices already mentioned.

[0152] The controller 1104 can communicate with the sensors 916 - 924 directly via the UART transceiver 1112 or via other buses or systems. Also, the controller 1104 can communicate with a brake controller 1124 that can brake or decelerate and stop the centrifuge 400. Similarly, the controller 1104 can communicate with a motor transceiver 1116, and the motor transceiver 1116 communicates with a motor power system or a motor controller that functions to spin up or rotate the centrifuge 400 or control the speed setting or other functions of the centrifuge 400.

[0153] In some forms, the controller 1104 can also communicate with a cuff controller 1122 that can change or set the pressure of the pressure cuff on the donor's arm during the apheresis process. Further, the controller 1104 can communicate with and / or control a strobe 1112 that can be any light that blinks periodically in synchronization with the rotational speed of the motor so that the operator of the apheresis system 200 can view the operation of the filler 460 as already described. Thus, the controller 1104 can communicate with the strobe 1112 to change the frequency of the blinking of the strobe light 1112, the intensity of the strobe light 1112, etc.

[0154] An embodiment of method 1200 used to complete blood component (e.g., plasma) apheresis using system 200 is shown in FIG. 12 in accordance with an embodiment of the present disclosure. Method 1200 can be described in relation to FIGS. 17A - 17T. Thus, method 1200 will be described with respect to or with reference to these figures. The general order in the steps of method 1200 is shown in FIG. 12. Generally, method 1200 begins with start step 1204 and ends at step 1220. Method 1200 can include more or fewer steps than this, or can set the order of steps differently than the order shown in FIG. 12. Method 1200 can be at least partially executed as a set of computer - executable instructions encoded or stored on a computer - readable medium and executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other devices. In other forms, method 1200 can be at least partially executed by a series of components, circuits, gates, etc. provided in a hardware device, such as a system - on - chip (SOC), an application - specific integrated circuit (ASIC), and / or a field - programmable gate array (FPGA). In the following, method 1200 will be described in relation to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, etc. described in relation to FIGS. 1 - 11.

[0155] Generally, method 1200 can be divided into three stages, where each stage includes a series of steps or processes. Each of the three stages is described in FIG. 12 and is described in relation to FIGS. 13 - 16 that illustrate the steps or processes. Method 1200 can include a system preparation stage in step 1208. In this stage 1208, an operator can prepare system 200 for apheresis, and the preparation may include steps such as inserting a needle into donor 102, performing other operations to prepare for blood collection, inserting blood component collection set 500 into the system, etc. Examples of steps that may be included in system preparation stage 1208 can be described in relation to FIG. 13.

[0156] Method 1200 may then enter a plasma draw stage in step 1212. Plasma draw stage 1212 can be described in relation to FIG. 14. Plasma draw stage 1212 can include drawing blood, centrifuging the blood to extract plasma (and / or other blood components), and pushing back high hematocrit blood (e.g., red blood cells) and / or other blood components to donor 102 in various return cycles (until the entire sample of plasma and / or other blood components is collected). The start of the return cycle may be triggered based on the presence of one or more blood components, such as platelets, red blood cells, etc., at some predetermined location within the apheresis system.

[0157] The final stage of method 1200 can be a disposable removal stage in step 1216. Disposable removal stage 1216 can be described in relation to FIG. 15. Disposable removal stage 1216 can include completion of the apheresis process, removal of the needle from donor 102, removal of blood component collection set 500, and completion of the procedure. Hereinafter, each of the three stages 1208 - 1216, and the steps or processes associated with these stages will be described.

[0158] The method of preparing the apheresis system 200 described in stage 1208 may be as shown in FIG. 13 according to an embodiment of the present disclosure. FIG. 13 shows the general order in the steps of method 1300. Generally, method 1300 starts from start step 1304 and ends at step 1328. Method 1300 can include more or fewer steps than this, or the order of the steps can be set differently from the order shown in FIG. 13. Method 1300 can be at least partially executed as a set of computer-executable instructions encoded or stored in a computer-readable medium and executed by a computer system, a processor, the cassette microcontroller 1004, the centrifuge microcontroller 1104, and / or other devices. In other forms, method 1300 may be at least partially executed by a series of components, circuits, gates, etc. provided in a hardware device, such as an SOC, an ASIC, and / or an FPGA. Hereinafter, method 1300 will be described in relation to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, methods, etc. described in FIGS. 1 to 12.

[0159] The user or operator attaches the blood component collection set 500 at step 1308. At this step 1308, the user can attach the blood component collection set 500 to the system 200, including inserting the flexible loop 524 into the loop storage bracket 426 and inserting the blood component collection bladder 536 into the filler 460 (both may be as described in FIG. 16). Further, the soft cassette 340 may be attached to the soft cassette assembly 300 as described in FIGS. 1, 2A, 2B, 3A, and / or 3B. The loop inlet tube 108B can be inserted into the lead tube guide 244 and / or the end tube guide 252 to the draw pump 208 to cause fluid movement in the loop inlet tube 108B and other parts of the blood component collection set 500. Similarly, the anticoagulant tube 110 can be placed in a tube guide similar to the guides 244, 252 so that the AC pump 216 can move the anticoagulant to the anticoagulant tube 110 or other parts of the blood component collection set 500. The loop outlet tube 112 can be inserted into a similar guide 244, 252 so that the return pump 212 can move a blood component (e.g., plasma) to the plasma collection bottle 122 or move saline from the saline bag 118 to the loop outlet tube 112 or other parts of the blood component collection set 500.

[0160] As shown in FIG. 2D, a saline-plasma tube y-connector 280 can be attached to a plasma-saline valve control system 228 so that valves 286, 288 can control the flow of fluid from and / or to the plasma collection bottle 122 and / or the saline bag 118. As described in FIGS. 1-2B, the AC bag 114 may be attached to the anticoagulant support 232A, the plasma collection bottle 122 can be placed within the plasma collection cradle 232C, and the saline bag 118 can be attached to the saline support 232B. With the blood component collection set 500 attached to the apheresis system 200, the apheresis system 200 is as shown in FIGS. 17 and 17B. The states of the various components of the apheresis system 200 are as shown below during this step.

[0161]

Table 1

[0162] As shown in the above table and subsequent tables, the draw pump 208 and the return pump 212 can each block the loop inlet tube 108B and the anticoagulant tube 110. Thus, the draw pump 208 and the return pump 212 function as "valves" that selectively permit or do not permit the flow of fluid. The minus sign "-" in the "Flow Rate" column indicates that the pump is operating in counterclockwise rotation. The abbreviation "AF" means "Auto-flow" and indicates that the pump is functioning at the flow rate of the blood coming from the donor 102. The AF flow rate prevents the apheresis system 200 from sucking blood from the donor 102 or returning the blood flow to the donor 102, and / or AF optimizes the draw and return flow rates while improving donor safety.

[0163] In step 1312, the saline bag 118 may be spiked. The user removes any safety cover from the bag spike fixture 512 at the distal end of the saline tube 116 and spikes the saline bag 118 that contains saline. In other forms, the saline tube 116 may be mechanically attached to the saline bag 118 (e.g., by a luer connector), and a breakable device or other removable barrier may be partially deformed by the user to allow the flow of saline from the saline bag 118. Thus, by spiking the saline bag 118, saline can flow into the blood component collection set 500 to or through the saline flow control valve 288. The states of the various components of the apheresis system 200 are as shown below during this step.

[0164]

Table 2

[0165] In step 1316, the physiological saline 1712 is primed. Priming of the physiological saline 1712 includes the cassette microcontroller 1004 instructing the opening of the physiological saline flow control valve 288, as shown in FIG. 17D. The cassette microcontroller 1004 can receive instructions or programs for the user interface to start the apheresis process that begins by priming the physiological saline 1712. Thus, the physiological saline 1712 moves from the physiological saline bag 118, through the physiological saline flow control valve 288, to the plasma air detection sensor 284. The cassette microcontroller 1004 instructs the reverse rotation of the return pump 212 to cause a volumetric flow of the physiological saline 1712 through the physiological saline tube 116 and the physiological saline / plasma tube y-connector 280 attached to the plasma / physiological saline valve control system 228 from the physiological saline bag 118 to the plasma air detection sensor 284. When the plasma air detection sensor 284 detects either the presence of liquid or the absence of air in the loop outlet tube 112, a signal is sent to the cassette microcontroller 1004. The cassette microcontroller 1004 then instructs the return pump 212 to stop rotating and instructs the physiological saline flow control valve 288 to close, thereby preventing the physiological saline 1712 from further entering the loop outlet tube 112 substantially beyond the plasma air detection sensor 284. At this point in the process, the apheresis system is as shown in FIG. 17E. The states of the various components of the apheresis system 200 are as follows during this step.

[0166]

Table 3

[0167] It should be noted that the return pump 212 is described as operating in a counterclockwise rotation. This direction of rotation is associated with the position of the return pump 212 relative to the loop outlet tube 112. When the return pump 212 is mounted with the loop outlet tube 112 below the return pump 212, the return pump 212 rotates in a clockwise direction to move the physiological saline 1712 from the physiological 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 those directions of rotation may be different if the pumps 208, 212, 216 are mounted or arranged differently. Additionally, other types of pumps may be used, whereby the way the pump operates to move various liquids or air within the system 200 may change. One of ordinary skill in the art can understand how to make these modifications to achieve similar results as described in the following processes and steps.

[0168] Furthermore, the amount and rate of movement within the apheresis system 200 are referred to or described in the tables included herein. However, these amounts and rates are determined by the size of the tubing, the size of the bags used, the desired amount of blood components to be collected (e.g., 880 mL of plasma), and other considerations. State or national laws and other directives may prescribe the amounts and rates used in the apheresis system 200, or these amounts and rates of movement can be predetermined based on the instructions of a medical professional or based on the characteristics of the donor 102. Thus, the amounts and rates of movement are for illustrative purposes only, and one of ordinary skill in the art can understand what amounts and rates of movement should be determined for the following steps and processes.

[0169] Next, in step 1320, the anticoagulant (AC) 1702 may be spiked. The spiking of the anticoagulant 1702 can be the same process as the spiking of the physiological saline 1712. For example, the user can attach the tube fixture 508 to the AC bag 114. At this time, the user destroys the breakable member or opens the valve or other device or deforms some structure to allow the AC 1702 to flow into the anticoagulant tube 110. In other forms, the user may pierce the AC bag 114 with a needle. At this point in the process, the apheresis system 200 becomes as shown in FIG. 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 spiked. The states of the various components of the apheresis system 200 are as follows during this step.

[0170]

Table 4

[0171] In response to a signal from the user, the cassette microcontroller 1004 then primes the AC 1702 in step 1324. To prime the AC 1702, the cassette microcontroller 1004 can instruct the AC pump 216 to operate or rotate in a clockwise direction to send the anticoagulant 1702 from the AC bag 114 to the anticoagulant tube 110, as shown in FIGS. 17F and 17G. The donor supply tube 104 is blocked by a clamp, a breakable device, or other structure. Thus, the AC 1702 does not flow from the donor supply tube 104 to the donor 102. Instead, the AC pump 216 can push the anticoagulant 1702 into the cassette inlet tube 108A, into the soft cassette 340, and partially into the loop inlet tube 108B. In embodiments, the AC 1702 flows through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316, but does not necessarily flow into the first tube section 368A or the second tube section 368B. Thus, the cassette microcontroller 1004 can close the first fluid control valve 320A to prevent the AC 1702 from flowing into the first tube section 368A, the drip chamber 354, or the second tube section 368B. Pre-positioning the AC 1702 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 the AC 1702 from being returned from the drip chamber 354 to the donor 102 when the red blood cells are returned later in the process.

[0172] To determine when to stop the AC pump 216, the cassette microcontroller 1004 can receive signals from the fluid sensor 316 and / or the donor air detection sensor 312 indicating that fluid is present in or passing through the sensors 312, 316. When the fluid sensor 316 provides the cassette microcontroller 1004 with notice that AC 1702 has reached the sensor 316, the cassette microcontroller 1004 can continue to instruct the AC pump 216 for a predetermined period until a known amount of AC 1702 is sent through the second cassette port 360B and partially into the loop inlet tube 108B. Thus, priming of the AC 1702 brings the apheresis system 200 to the state shown in FIG. 17G. The states of the various components of the apheresis system 200 are as follows during this step.

[0173]

Table 5

[0174] In some forms, as shown in FIG. 17G, the direction of the AC pump 216 may be reversed. At least a portion of the anticoagulant 1702 may then be sent back to the AC bag 114 and / or to a portion of the cassette inlet tube 108A and / or the anticoagulant tube 110. In an embodiment, the cassette microcontroller 1004 can instruct the draw fluid control valve 320C to close and hold the AC in the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The donor air detection sensor 312 can determine when the AC 1702 stops passing through the sensor 312 and send a signal to the cassette microcontroller 1004. In this case as well, the cassette microcontroller 1004 can continue to instruct the AC pump 216 for a predetermined period until a known amount of AC 1702 is sent back through the cassette inlet tube 108A. Thus, the AC 1702 places the apheresis system 200 in the state shown in FIG. 17H. The amount of anticoagulant remaining in the cassette inlet tube 108A, the tube connector 106, and / or the anticoagulant tube 110 may be determined by the cassette microcontroller 1004 up to a predetermined time after the anticoagulant 1702 has passed through the donor air detection sensor 312. This process leaves some anticoagulant in the cassette inlet tube 108A but reduces the amount of AC used to avoid the problem of incoming whole blood being mixed with an excessive amount of AC. At this point, the apheresis system 200 is ready and, in stage 1212 (FIG. 12), is in a state where whole blood can be drawn at any time. The states of the various components of the apheresis system 200 are as follows during this step.

[0175]

Table 6

[0176] One embodiment of method 1400 representing plasma draw stage 1212 is shown in FIG. 14 in accordance with an embodiment of the present disclosure. FIG. 14 shows the general order in the steps of method 1400. Generally, method 1400 begins with start step 1404 and ends at step 1440. Method 1400 can include more or fewer steps than this, or the order of the steps can be set differently than the order shown in FIG. 14. Method 1400 can be at least partially executed as a set of computer-executable instructions encoded or stored in a computer-readable medium and executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other device. In other forms, method 1400 can be at least partially executed by a series of components, circuits, gates, etc. provided in a hardware device, such as a SOC, ASIC, and / or FPGA. Hereinafter, method 1400 will be described in relation to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, methods, etc. described in relation to FIGS. 1-13.

[0177] In step 1408, the donor 102 may be punctured with a needle. A phlebotomist, apheresis technician, or other medical professional can attach a needle with a lumen to the tube fixture 504 and place the needle into a blood vessel (e.g., vein) of the donor 102. Thus, the apheresis system 200 may be fluidly connected to the donor 102 and in a state where whole blood can be drawn at any time. Therefore, the apheresis system 200 starts the plasma draw stage 1212 in a state where the donor 102 can supply whole blood at any time as shown in FIG. 17H. The states of various components of the apheresis system 200 are as follows during this step.

[0178] [Table 7]

[0179] The cassette microcontroller 1004 of the apheresis system 200 can start drawing in whole blood 1706 at step 1412. The cassette microcontroller 1004 instructs the AC pump 216, the draw pump 208, and / or the return pump 212 to operate by rotating in a clockwise direction. The AC pump 216 pushes the anticoagulant 1702 toward the plasma collection bottle 122 so that the anticoagulant 1702 mixes with the whole blood 1706 drawn into the tube connector 106 from the donor 102 (and, optionally, within the donor supply tube 104) and other components distal to the tube connector 106 and the AC 1702. The draw pump 208 and / or the return pump 212 draw in the whole blood 1706 (and AC) from the donor 102 into the soft cassette 340, within the flexible loop 524, and / or within the blood component collection bladder 536. During this process 1412, the cassette microcontroller 1004 and the centrifuge microcontroller 1008 can communicate to inform the centrifuge microcontroller 1008 that the draw has started. In response to the notification of the start of the draw, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to start rotating or spinning. The initial rotation speed may be slower so that the blood component collection bladder 536 can be seated within the filler insertion chamber 492 and the whole blood 1706 can be drawn into the blood component collection bladder 536. The state of the apheresis system 200 during this step 1412 is as shown in FIG. 17I. The states of the various components of the apheresis system 200 are as shown below during this step.

[0180]

Table 8

[0181] In step 1416, whole blood 1706 is primed in the region of the blood component collection bladder 536 adjacent to the channel inlet 468, the channel end 472, and / or the channel path jog 476. The cassette microcontroller 1004 stops the operation of the return pump 212, but continues to operate the AC pump 216 and the draw pump 208. Whole blood 1706 is pushed forward through the first tube section 368A, the drip chamber 354, and / or the second tube section 368B. From the soft cassette 340, whole blood 1706 is pushed into the blood component collection bladder 536 through the flexible loop 524 and pushed towards the bladder free end 540B. The anticoagulant pump 216 continues to operate to mix the anticoagulant 1702 from the anticoagulant bag 114 with the whole blood 1706 drawn from the donor 102. The apheresis system 200 becomes as shown in FIG. 17J during step 1416. The states of the various components of the apheresis system 200 are as shown below during this step.

[0182]

Table 9

[0183] Further communication is performed between the cassette microcontroller 1004 and the centrifuge microcontroller 1008 to notify the priming of the channel. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to start rotating or spinning at a higher rotational speed (RPM).

[0184] Referring now to step 1420, the cassette microcontroller 1004 begins to effect the initial draw of plasma 1704 or other blood components from whole blood 1706. The cassette microcontroller 1004 continues to operate the AC pump 216 to supply anticoagulant 1702 to the cassette inlet tube 108A for mixing with whole blood 1706 from donor 102. Further, the cassette microcontroller 1004 continues to operate the draw pump 208 to move whole blood 1706 into the blood component collection bladder 536 to separate plasma 1704 from whole blood 1706. To effect the separation of plasma 1704, the cassette microcontroller 1004 notifies the centrifuge microcontroller 1008 that the draw 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 FIG. 17K. The draw pump 208 continues to push plasma 1704 through the flexible loop 524, system fixed loop connector 528 into the loop outlet tube 112. The draw process 1420 continues until at some point, as shown in FIG. 17L, platelets 1710 separated from whole blood 1706 reach the line sensor 812, and the line sensor 812 signals the cassette microcontroller 1004 that the entire volume of plasma 1704 has been extracted from whole blood 1706 pushed into the blood component collection bladder 536. Then, the cassette microcontroller 1004 proceeds to step 1424. The states of the various components of the apheresis system 200 are as follows during this step.

[0185]

Table 10

[0186] When platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach the line sensor 812 and that arrival is determined by the sensor 812 that observes a change in the color of the fluid or other characteristics, the cassette microcontroller 1004 determines, in step 1426, whether the donor contribution is complete. A complete donor contribution means that the entire amount of plasma 1704 required or desired has been drawn in and placed in the plasma collection bottle 122. In an embodiment, the cassette microcontroller 1004 can determine whether a complete donor contribution (e.g., 880 mL) has been withdrawn by weight or by volume. This situation is shown in FIG. 17L, where the plasma 1704 has been withdrawn and still exists within the loop outlet tube 112 and is supplied through the plasma tube 120 to the plasma collection bottle 122. If it is an incomplete donor contribution (i.e., the plasma collection bottle 122 has not reached the desired weight limit or volume limit), the process 1400 goes to NO and transfers back to step 1428. If it is a complete donor contribution, the method 1400 goes to YES and transfers to the last return step 1432.

[0187] In the return step 1428 depicted in FIG. 17L, the cassette microcontroller 1004 instructs the draw pump 208 to stop and reverses the direction of the return pump 212 to operate in a counterclockwise motion, pushing the plasma 1704 from the plasma collection bottle 122 through the plasma tube 120 to the loop outlet tube 112 and towards the soft cassette 340. The cassette microcontroller 1004 further instructs the draw fluid control valve 320C to close and further instructs both the first fluid control valve 320A and the second fluid control valve 320B to open. With these configuration changes, the plasma 1704 pushes the red blood cells 1708 and platelets 1710 out of the loop outlet tube 112, through the flexible loop 524, the blood component collection bladder 536, through the drip chamber 354, and towards the donor 102. Importantly, as can be seen in FIG. 17L, the filler 460 continues to rotate at an extraction speed, for example 5000 RPM, during this return step 1428. The system 200 continues to push the red blood cells 1708 back towards the donor 102 as shown in FIG. 17M until the color / pressure sensor 808 determines that there is a possibility that the plasma 1704 has passed through the sensor 808 and reached the drip chamber 354. At that point, the valves 320B, 320A are closed again and the whole blood 1706 can flow again through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The states of the various components of the apheresis system 200 are as shown below during this step 1428.

[0188]

Table 11

[0189] The return step 1428 then proceeds to the second draw step 1420. The new draw 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 collection bladder 536, and more plasma 1704 cannot be extracted from the red blood cells. Thus, the bypass provided by the soft cassette 340 makes the removal of plasma 1704 from the whole blood 1706 in the second draw step 1420 and subsequent draw steps more efficient.

[0190] The return step 1428 and the continuing draw step 1420 are repeated several times. The last draw step 1420 is shown in FIG. 17N. As shown in FIG. 17N, the plasma 1704 in the plasma collection bottle 122 has reached the desired and / or maximum amount, for example 880 mL. At this point, in step 1432, a final return is required. The states of the various components of the apheresis system 200 are as follows during this step.

[0191]

Table 12

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

[0193] After or as part of the last return 1432, in step 1436, as shown in FIG. 17O, physiological saline 1712 may be returned to donor 102. In this step 1436, the cassette microcontroller 1004 opens the physiological saline flow control valve 288 and keeps the first fluid control valve 320A and the second fluid control valve 320A open. The return pump 212 continues to operate in the counterclockwise direction. The centrifuge microcontroller 1008 stops the filler 460 from rotating. The physiological saline 1712 from the physiological saline bag 118 is pushed back to the donor 102 through the blood component collection bladder 536, the drip chamber 354, and various tubes. Various blood components remaining in the blood component collection set 500 are pushed back to the donor 102 together with some amount of physiological saline 1712. The physiological saline 1712 helps to replenish the fluid for the donor 102 and is required in some jurisdictions. The return of this physiological saline 1712 continues until a predetermined amount of physiological saline 1712, determined by the weight or volume of the physiological saline 1712 that has exited the physiological saline bag 118, is supplied to the user. At this point, as shown in FIG. 17O, the plasma donor provision is complete. The states of the various components of the apheresis system 200 are as follows during this step.

[0194]

Table 13

[0195] An embodiment of a method for removing a plasma and blood component collection set 500 as described in the removal stage 1216 from the apheresis system 200 is shown in FIG. 15 in accordance with an embodiment of the present disclosure. FIG. 15 shows a general order in the steps of method 1500. Generally, method 1500 begins at start step 1504 and ends at step 1528. Method 1500 can include more or fewer steps than this, or the order of the steps can be set differently from the order shown in FIG. 15. Method 1500 can be at least partially executed as a set of computer-executable instructions encoded or stored on a computer-readable medium and executed by a computer system, a processor, a cassette microcontroller 1004, a centrifuge microcontroller 1104, and / or other devices. In other forms, method 1500 may be at least partially executed by a series of components, circuits, gates, etc. provided in a hardware device, such as an SOC, an ASIC, and / or an FPGA. Hereinafter, method 1500 will be described in relation to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, methods, etc. described in relation to FIGS. 1 to 14.

[0196] In step 1508, the channel is evacuated. In an embodiment, the cassette microcontroller 1004 operates the draw pump 208 in a counterclockwise direction to continuously push the physiological saline 1712 out of the blood component collection bladder 536 and the rest of the blood component collection set 500, as shown in FIG. 17P. At some point, substantially all of the blood components and / or physiological saline 1712 are pushed back into the donor 102, in which case all of the pumps 216, 208, 212 stop operating. Then, the fluid control valve 320A, the first fluid control valve 320A, the physiological saline flow control valve 288, and any other valves are closed by the cassette microcontroller 1004. At this point, there should be little or no physiological saline 1712 remaining in the blood component collection set 500. The state of the apheresis system 200 is shown in FIG. 17Q. The states of the various components of the apheresis system 200 are as follows during this step.

[0197]

Table 14

[0198] At this point, in step 1512, as shown in FIG. 17R, the blood component collection set 500 can be sealed. Sealing the blood component collection set 500 can include clamping the donor supply tube 104 leading to the donor 102 and heat-sealing the tubes at various locations. As shown in FIG. 17R, if the tubes are made of a thermoplastic material, the seal is performed by heat-fusing the tubes. For example, the anticoagulant tube 110, the physiological saline tube 116, the plasma tube 120 (above the plasma flow control valve 286), and the donor supply tube 104 are all heat-fused to separate the AC bag 114, the plasma collection bottle 122, the physiological saline bag 118, and the donor 102 from the rest of the blood component collection set 500. The states of the various components of the apheresis system 200 are as follows during this step.

[0199]

Table 15

[0200] At this point, in step 1516, as shown in FIG. 17R, the needle is removed from the donor 102. The states of the various components of the apheresis system 200 are as follows during this step.

[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 part of the procedure described in connection with FIGS. 13 and 16. The states of the various components of the apheresis system 200 are as follows during this step.

[0203]

Table 17

[0204] Once removed, the used blood component collection set 500 can be discarded as medical waste. As shown in FIG. 17S, the plasma collection bottle 122 may be sealed on the plasma tube 120. As a result, the seal area can prevent any liquid from leaking out of the plasma collection bottle 122, the saline bag 118, or the anticoagulant bag 114. And in any procedure where plasma is required, the plasma collection bottle 122 can be removed and used. The remaining members may be discarded as medical waste, and as shown in FIG. 17T, in step 1524, the procedure is completed. The states of the various components of the apheresis system 200 are as follows during this step.

[0205]

Table 18

[0206] An embodiment of method 1600 for inserting a disposable item into the filler of apheresis system 200 may be as shown in FIG. 16, in accordance with an embodiment of the present disclosure. FIG. 16 shows the general order in the steps of method 1600. Generally, method 1600 begins with start step 1604 and ends at step 1632. Method 1600 can include more or fewer steps than this, or the order of the steps can be set differently than the order shown in FIG. 16. Method 1600 can be at least partially executed as a set of computer-executable instructions encoded or stored in a computer-readable medium and executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other devices. In other forms, method 1600 may be at least partially executed by a series of components, circuits, gates, etc. provided in a hardware device, such as an SOC, an ASIC, and / or an FPGA. Hereinafter, method 1600 will be described in relation to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal transmission processes, models, environments, apheresis systems, methods, etc. described in relation to FIGS. 1-15.

[0207] In step 1608, a filler 460 of the apheresis system 200 is prepared. The filler 460 can be a component of the apheresis system 200 and is configured to receive at least a portion of the blood component collection set 500. In an embodiment, the filler 460 is mounted on a split housing rotation axis 406 that rotates to expose the interior of the upper housing 404B that includes the filler 460. The user may rotate the upper housing 404B to expose the collection insertion channel 466, or in some embodiments, the filler 460 may be automatically rotated by a motor or other mechanical device. This rotation and / or attachment may be as described in connection with FIGS. 4D-4F and / or FIGS. 6A-6C described above.

[0208] In step 1612, a blood component collection set 500 including a blood component collection bladder 536 is prepared. The blood component collection set 500 is packaged and removed from the package. The user exposes the blood component collection bladder 536 for insertion into the collection insertion channel 466. This includes ensuring that the bladder free end 540B is positioned in the channel path jog 476 of the collection insertion channel 466 and that the filler loop connector 532 is positioned in the loop connection region 454. With the blood component collection bladder 536 properly positioned, the user can, as shown in FIGS. 5F-5H, in step 1616, deform the blood component collection bladder 536 into the shape of the generally collection insertion channel 466 and the channel path jog 476. Thus, the user can form the blood component collection bladder 536 into a generally circular shape or any other shape that conforms to the shape of the collection insertion channel 466.

[0209] Then, at step 1620, as shown in FIGS. 5G-5H, with the bladder free end 540B of the blood component collection bladder 536 inserted into the channel path jog 476 of the collection insertion channel 466, the blood component collection bladder 536 adjusted to the shape is inserted into the collection insertion channel 466 of the filler 460. The user can insert the blood component collection bladder 536 into the collection insertion channel 466 at a substantially central position within the filler insertion chamber 492. Due to centrifugal force, the blood component collection bladder 536 is automatically aligned to the correct position within the filler insertion chamber 492. However, if it is not positioned when the centrifugal force acts on the blood component collection bladder 536, the blood component collection bladder 536 can be removed from the collection insertion channel 466. When positioned, the blood component collection bladder 536 is fixed in place.

[0210] At step 1624, the user can connect the filler loop connector 532 of the blood component collection bladder 536 to the loop connection region 454 of the collection insertion channel 466. A mechanical connection may be made by the user snap-engaging the filler loop connector 532 to the loop connection region 454. At this time, the dimensions and physical characteristics of the filler insertion chamber 492 are such that the blood component collection bladder 536 can be held in a stable position where the filler loop connector 532 is in a stable state within the loop connection region 454 and the blood component collection bladder 536 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 exterior to the filler 460 can be 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 attached, at step 1628, the upper housing 404B is inverted to a predetermined position. Accordingly, the filler 460 may be rotated into the interior of the system housing 204 by a hinge axis 406 (e.g., a hinge, etc.). Then, the centrifuge housing 404 is rotated with the blood component collection loop 520 passing through the loop access clearance 436 of the centrifuge split housing 404. When the blood component collection loop 520 is attached to the loop loading position 520A, a portion of the blood component collection loop 520 is partially received, held, and / or supported by the loop storage bracket 426, as described in connection with FIGS. 4A - 4C. The access panel 224 is rotated to a closed position that enables operation of the system 200.

[0212] The exemplary systems and methods of this disclosure have been described with respect to an apheresis method and system. However, to avoid unnecessarily obscuring this disclosure, the previous description has omitted many well - known structures and devices. This omission should not be construed as limiting the scope of the disclosure recited in the claims. Specific detailed descriptions are provided to give an understanding of this disclosure. However, it should be understood that this disclosure may be practiced in various ways other than those specifically detailed herein.

[0213] Furthermore, the exemplary aspects, embodiments, and / or configurations illustrated herein show various components of the system being deployed, but particular components of the system can be located remotely in a distributed network such as a LAN and / or the Internet, or within a dedicated system. Thus, it should be understood that the components of the system can be combined into one or more devices such as cassette node 904 and centrifuge node 908, or the components of the system can be arranged at specific nodes of a distributed network such as an analog and / or digital remote communication network, a packet-switch network, or a circuit-switch network. From the foregoing description, it should also be understood that, for computational efficiency, the components of the system can be arranged at any location within the distributed network of 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, a site of one or more users, or some combination thereof. Similarly, one or more functional portions of the system can be disposed between a remote communication device and a computer device associated therewith.

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

[0215] Also, although flowcharts have been discussed and illustrated with respect to a particular sequence of events, it should be understood that changes, additions, and omissions can be made to this sequence without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0216] Many variations and modifications of the present disclosure can be used. Some features of the present disclosure can be provided without giving other features.

[0217] In still other embodiments, the systems and methods of this disclosure can 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, hard-wired logic circuitry such as electronic devices or individual element circuits, a programmable logic device or gate array, such as a PLD, PLA, FPGA, PAL, a dedicated computer, any equivalent means, etc. Generally, any device or means capable of implementing the methodologies shown herein can be used to implement various aspects of this disclosure. Typical hardware that can be used for the disclosed embodiments, configurations, and aspects includes computers, portable devices, telephones (e.g., mobile phones, Internet-capable, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include a processor (e.g., a single or multiple microprocessors), memory, non-volatile storage devices, input devices, and output devices. Additionally, other software implementations including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing can be constructed to implement the methods described herein.

[0218] In still other embodiments, the disclosed method may be readily implemented in connection with software that provides portable source code for use on various computer or workstation platforms or with object or object-oriented software development environments. Alternatively, the disclosed system may be implemented partially or fully in hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement the system according to this disclosure depends on the speed and / or efficiency requirements of the system, particular functions, and the particular software or hardware systems or microprocessors or microcomputer systems being utilized.

[0219] In still other embodiments, the disclosed method may be implemented in part in software stored on a storage medium and executed on a general purpose computer, a dedicated computer, a microprocessor, etc., programmed with the cooperation of a controller and memory. In these cases, the systems and methods of this disclosure may be implemented as programs incorporated into a personal computer such as an applet, JAVA (registered trademark) or CGI script, as resources existing on a server or computer workstation, as a dedicated measurement system, as routines incorporated into system components, etc. Also, the system may be implemented by physically incorporating the system and / or method into a software and / or hardware system.

[0220] This disclosure describes aspects, embodiments, and / or configurations implemented in components and functions related to specific standard specifications and protocols. However, the aspects, embodiments, and / or configurations are not limited to such standard specifications and protocols. There are other similar standard specifications and protocols not mentioned herein, and these are considered to be included in this disclosure. Further, the standard specifications and protocols mentioned herein and other similar standard specifications and protocols not mentioned herein are periodically replaced by faster or more effective equivalents having substantially the same functions. Such alternative standard specifications and protocols having the same functions are considered to be equivalents included in this disclosure.

[0221] This disclosure of various aspects, embodiments, and / or configurations includes components, methods, processes, systems, and / or devices substantially as illustrated and described herein, including various aspects, embodiments, configuration embodiments, sub - combinations, and / or subsets thereof. Those skilled in the art can understand how to create and use the disclosed aspects, embodiments, and / or configurations after understanding this disclosure. This disclosure of various aspects, embodiments, and / or configurations can provide devices and processes in the absence of items not illustrated and / or not described herein, including in the absence of items that could have been used in prior devices or processes, for example, to improve performance, obtain ease, and / or reduce implementation costs.

[0222] The foregoing description has been presented for purposes of illustration and description. It is not intended to limit the disclosure to one or more forms disclosed herein. For example, in the foregoing detailed description, for the purpose of simplifying the disclosure, various features of the present disclosure are grouped together in one or more aspects, embodiments, and / or configurations. The features of the aspects, embodiments, and / or configurations of the present disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those described above. This method of disclosure should not be construed as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, aspects of the invention lie in less than all of the features of the single disclosed aspect, embodiment, and / or configuration described above. Accordingly, the following claims are hereby incorporated into this detailed description, with each claim standing on its own as a separate preferred embodiment of the present disclosure.

[0223] Furthermore, the body of the specification has included descriptions of one or more aspects, embodiments, and / or configurations, and specific variations and modifications, but other variations, combinations, and modifications are within the scope of the present disclosure after understanding the present disclosure, and can be, for example, within the skills and knowledge of those skilled in the art. It is intended to obtain to the extent permitted rights to include other aspects, embodiments, and / or configurations, including replaceable and / or equivalent structures, functions, scopes, or steps that replace those described in the claims, whether or not such replaceable and / or equivalent structures, functions, scopes, or steps are disclosed herein, and without attempting to publicly use any patentable subject matter.

Claims

1. 1. A method for collecting blood components by apheresis, the method comprising: Drawing whole blood from a donor 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 third blood component; Separating a first blood component from the whole blood; extracting the first blood component into a container; detecting that a second blood component is being extracted; after the second blood component is detected, while the centrifuge continues to rotate, returning the separated first blood component to the centrifuge and removing at least the third blood component from the centrifuge and returning it to the donor; The method includes:

2. 2. The method of claim 1, the first blood component being one or more of plasma, platelets, red blood cells, and / or high hematocrit blood; method.

3. 3. The method according to claim 1 or 2, the second blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood, and the third blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood; method.

4. The method according to any one of claims 1 to 3, the first blood component being two or more of plasma, platelets, red blood cells, and / or high hematocrit blood; method.

5. The method according to any one of claims 1 to 4, the centrifuge rotates at a first speed when separating the first blood component from the whole blood. method.

6. 6. The method of claim 5, the centrifuge continues to rotate at the first speed as the separated first blood component is returned to the centrifuge. method.

7. The method according to any one of claims 1 to 6, the centrifuge spins at a second speed as whole blood is drawn from the donor into the centrifuge. method.

8. 8. The method of claim 7, The second speed is slower than the first speed. method.

9. The method according to any one of claims 1 to 8, the first blood component is separated from the whole blood in a blood component collection set that is inserted into the centrifuge; method.

10. 10. The method of claim 9, the centrifuge includes a filler that rotates a blood component collection bladder associated with the blood component collection set. method.

11. 11. The method of claim 10, the blood component collection bladder is inserted into and held in a collection insertion channel formed in the filler; method.

12. In the apheresis system, a first tube having a lumen, fluidly associated with the needle and adapted to move whole blood from the donor through the lumen; a draw pump engaged with the first tube to draw the whole blood into a centrifuge; the centrifuge rotating the whole blood so as to apply a centrifugal force to the whole blood, thereby separating the whole blood into at least a first blood component and a third blood component; a blood component collection bladder inserted into the centrifuge and in fluid communication with the first tube and configured to separate the first blood component from the whole blood; a second tube fluidly associated with the blood component collection bladder for transferring the first blood component from the blood component collection bladder; a collection container in fluid communication with the second tube for extracting the first blood component from the apheresis system; a sensor located in physical proximity to the second tube for detecting when a second blood component is being extracted from the whole blood; a return pump engaged with the second tube to return the separated first blood component through the second tube to the blood component collection bladder and to move at least the third blood component from the blood component collection bladder back to the donor after the second blood component is detected by the sensor while the centrifuge continues to rotate; An apheresis system comprising:

13. 13. The apheresis system of claim 12, the first blood component is plasma and the second blood component is platelets, red blood cells, and / or high hematocrit blood; Apheresis system.

14. The apheresis system according to claim 12 or 13, an anticoagulant pump for drawing anticoagulant from an anticoagulant bag and mixing the anticoagulant with the whole blood at a manifold or junction in fluid association with the first tube. Apheresis system.

15. The apheresis system according to any one of claims 12 to 14, the centrifuge includes a filler that rotates the blood component collection bladder. Apheresis system.

16. 16. The apheresis system of claim 15, the blood component collection bladder is inserted into and held in a collection insertion channel formed in the filler; Apheresis system.

17. 1. A blood component collection set associated with an apheresis system, the set comprising: a needle that is inserted into a donor's vein to draw whole blood from the donor; a first tube having a lumen, fluidly associated with the needle and configured to move whole blood through the lumen, a draw pump engaged with the first tube to draw the whole blood from the donor; a blood component collection bladder that is inserted into a centrifuge and is fluidly associated with the first tube and that separates a first blood component and a third blood component from the whole blood; a second tube fluidly associated with the blood component collection bladder for transferring the first blood component from the blood component collection bladder; a collection container in fluid communication with the second tube for extracting the first blood component from the apheresis system, wherein a sensor is located in physical proximity to the second tube for detecting when a second blood component is being extracted from the whole blood, and after the second blood component is detected by the sensor, a return pump engaged with the second tube returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor while the centrifuge continues to spin; A blood component collection set comprising:

18. 20. The blood component collection set of claim 17, The first blood component is plasma and the second blood component is platelets. Blood component collection set.

19. 19. The blood component collection set according to claim 17 or 18, the draw pump is disengaged when the return pump returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor. Blood component collection set.

20. The blood component collection set according to any one of claims 17 to 19, the blood component collection bladder is inserted into and held within a filler that rotates the blood component collection bladder in the centrifuge; Blood component collection set.

21. 1. An assembly for separating a component from a multi-component fluid, the assembly comprising: a filler having a channel for holding a separation bladder of a disposable item, the channel having two opposing walls; a loop rotation positioning guide having a plurality of bearings, the loop rotation positioning guide retaining a flexible loop of a disposable item when the separation bladder is installed within the channel; An assembly comprising:

22. 22. The assembly of claim 21, The loop rotation positioning guide includes a stopper plate. assembly.

23. 23. An assembly according to claim 21 or 22, the flexible loop contacts the stop plate when held within the loop rotation positioning guide; assembly.

24. An assembly according to any one of claims 21 to 23, the assembly being part of an apheresis device; assembly.

25. An assembly according to any one of claims 21 to 24, The assembly is connected to a rotor that rotates the loop rotation positioning guide about an axis of rotation. assembly.

26. An assembly according to any one of claims 21 to 25, the plurality of bearings comprises a plurality of pairs of roller bearings; assembly.

27. 1. A centrifuge assembly comprising: a centrifuge housing having an exterior surface and an interior cavity, the centrifuge housing rotating about an axis of rotation of the centrifuge assembly; a fluid separation body disposed at least partially within the interior cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the axis of rotation; a fluid line loop arm attached to a portion of the centrifuge housing and extending along a length of the exterior surface of the centrifuge housing; Equipped with the fluid line loop arm includes a bearing set disposed at a point along the length of the outer surface; the bearing set is configured to contact tubing portions of interconnected fluid line loops to hold 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. Centrifuge assembly.

28. 28. The centrifuge assembly of claim 27, The bearing set comprises a pair of roller bearings. Centrifuge assembly.

29. 29. The centrifuge assembly of claim 27 or 28, The bearing set includes a plurality of pairs of roller bearings. Centrifuge assembly.

30. A centrifuge assembly according to any one of claims 27 to 29, The centrifuge assembly is part of an apheresis device. Centrifuge assembly.

31. 31. The centrifuge assembly of claim 30, the fluid line loop is attached at a first end of the fluid line loop to a stationary, non-rotating portion of the apheresis device via a first positively-located connector, and the fluid line loop is interconnected at a second end of the fluid line loop to the fluid separation body within the internal cavity via a second positively-located connector. Centrifuge assembly.

32. 32. The centrifuge assembly of claim 31, the second end of the fluid line loop rotates with the fluid separation body; Centrifuge assembly.

33. 33. The centrifuge assembly of claim 31 or 32, the fluid line loop is physically and fluidly attached to a disposable fluid isolation bladder at the second positive positioning connector; Centrifuge assembly.

34. 34. The centrifuge assembly of claim 33, the fluid line loop comprises a plurality of lumens, the fluid isolation bladder comprises a first flexible sheet attached to a second flexible sheet to form a fluid pathway, a first portion of the fluid pathway being narrower than a second portion of the fluid pathway; Centrifuge assembly.

35. 1. A method for automatically installing a fluid line loop in a centrifuge assembly, the method comprising: attaching the fluid line loop at a first end to a fluid separation body of the centrifuge assembly; rotating the fluid separation body in a first rotational direction relative to a housing of the centrifuge assembly, the rotating fluid separation body rotating the fluid line loop relative to the housing and directing the fluid line loop into a channel of a loop arm attached to a portion of the housing; Including, the channel includes a bearing disposed in a bearing set attached to the loop arm, the bearing holding the fluid line loop in position relative to the housing as the centrifuge assembly rotates; The method includes:

36. 36. The method of claim 35, the bearing contacts a portion of the fluid line loop when the fluid line loop rotates in the channel relative to the housing at the predetermined position. method.

37. 37. The method of claim 35 or 36, the centrifuge housing rotates in a first rotational direction at a first angular velocity about an axis of rotation, and the fluid separation body is forced to rotate at a different second angular velocity about the axis of rotation by a torsional force imparted by the fluid line loop; method.

38. 38. The method of claim 37, The second angular velocity is approximately twice the first angular velocity. method.

39. The method according to any one of claims 35 to 38, the fluid line loop is physically and fluidly attached to a disposable fluid isolation bladder that is at least partially disposed within the fluid isolation body; method.

40. The method according to any one of claims 35 to 39, attaching a second end of the fluid line loop to a rotationally fixed point on the apheresis device; rotating the centrifuge assembly about the axis of rotation via a rotor-motor assembly of the apheresis device relative to the rotationally fixed point of the apheresis device; The method further comprises:

41. 1. A filler for holding a separation bladder in which components are separated from a composite fluid, comprising: The filler is a channel for holding a separation bladder during separation of components from the composite fluid; The channel comprises: The first wall, a second wall opposite the first wall; Equipped with a first end of the channel is adjacent a center portion of the filler and the channel spirals toward an outer periphery of the filler; Filler.

42. 42. The filler of claim 41, The upper end of the channel is narrower than the center of the channel. Filler.

43. 43. The filler according to claim 41 or 42, At least a portion of the second wall has a concave surface. Filler.

44. The filler according to any one of claims 41 to 43, the second end of the channel is positioned to be subjected to a higher gravitational force than the first end during separation; Filler.

45. The filler according to any one of claims 41 to 44, an upper end of the channel provides reinforcement for the separation bladder during separation; Filler.

46. A fluid separation filler comprising: a body having an axis of rotation disposed at approximately a center of mass of the body; a fluid collection insertion channel disposed within the body and following a generally helical path extending spirally outwardly from a first point proximate the axis of rotation to a second point disposed proximate the circumference of the body; Equipped with the fluid collection insertion channel curves outwardly toward a circumference of the body proximate an end of the generally helical path that defines a third point of the fluid collection insertion channel disposed furthest from the axis of rotation. Fluid separation filler.

47. 47. The fluid separation filler of claim 46, and a fluid collection chamber disposed within the body and following a portion of the generally helical path, the fluid collection insertion channel connecting to the fluid collection chamber and defining an access area between an interior of the fluid collection chamber and an exterior of the body. Fluid separation filler.

48. 48. The fluid separation filler of claim 47, the fluid collection chamber is configured to receive a disposable fluid collection bladder; Fluid separation filler.

49. The fluid separation filler according to any one of claims 46 to 48, a dimension from the axis of rotation to the third point of the generally helical path is greater than a dimension from the axis of rotation to the second point of the generally helical path; Fluid separation filler.

50. The fluid separation filler according to any one of claims 46 to 49, a width of the fluid collection chamber at a point along the generally helical path is greater than a width of the fluid collection insertion channel at the point along the generally helical path; Fluid separation filler.

51. 49. The fluid separation filler of claim 47 or 48, the fluid collection chamber further comprising a first wall following an innermost portion of the generally spiral path and a second wall generally parallel to the first wall and following an outermost portion of the generally spiral path. Fluid separation filler.

52. 52. The fluid separation filler of claim 51, the fluid collection chamber further comprising one or more tapered walls disposed between the first wall and the second wall, the one or more tapered walls configured to guide the disposable fluid collection bladder into a seated position within the fluid collection chamber. Fluid separation filler.

53. 53. The fluid separation filler of claim 52, a fluid inlet for the disposable fluid collection bladder when installed within the fluid collection chamber is disposed adjacent the axis of rotation, a first fluid path of the disposable fluid collection bladder following the generally spiral path outwardly toward an end of the disposable fluid collection bladder disposed adjacent the third point of the fluid collection insertion channel that is disposed furthest from the axis of rotation, and fluidly interconnecting with a second fluid path separate from the first fluid path of the disposable fluid collection bladder and extending in an inward direction from the third point following the generally spiral path to a fluid outlet for the disposable fluid collection bladder disposed adjacent the axis of rotation. Fluid separation filler.

54. 54. The fluid separation filler of claim 53, the fluid inlet and the fluid outlet are part of a connector that is attached to the disposable fluid collection bladder, and the body of the fluid isolation filler includes connection points that engage with the connector. Fluid separation filler.

55. 55. The fluid separation filler of claim 54, the connector includes at least one key feature and the connection point includes at least one mating key feature, the key feature positively positions the connector relative to the connection point; Fluid separation filler.

56. 1. A centrifuge assembly comprising: a centrifuge housing having an internal cavity and adapted to rotate about an axis of rotation of the centrifuge assembly; a fluid separation body disposed at least partially within the interior cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the axis of rotation; Equipped with the fluid separation body includes a fluid collection insertion channel disposed therein and following a generally helical path extending spirally outwardly from a first point adjacent the axis of rotation to a second point disposed adjacent an outer periphery of the fluid separation body; the fluid collection insertion channel curves outwardly toward an outer periphery of the body proximate an end of the generally helical path that defines a third point of the fluid collection insertion channel disposed furthest from the axis of rotation. Centrifuge assembly.

57. 57. The centrifuge assembly of claim 56, the fluid separation body further comprising a fluid collection chamber disposed within the body and following a portion of the generally helical path, the fluid collection insertion channel connecting to the fluid collection chamber to define an access area between an interior of the fluid collection chamber and an exterior of the fluid separation body. Centrifuge assembly.

58. 58. The centrifuge assembly of claim 57, a disposable fluid collection bladder disposed within the fluid collection chamber and following the generally spiral path, the disposable fluid collection bladder including a fluid inlet disposed adjacent the axis of rotation, a first fluid path of the disposable fluid collection bladder following the generally spiral path outwardly toward an end of the disposable fluid collection bladder disposed adjacent the third point of the fluid collection insertion channel disposed furthest from the axis of rotation, and fluidly interconnecting with a second fluid path separated from the first fluid path of the disposable fluid collection bladder and extending in an inward direction from the third point following the generally spiral path to a fluid outlet for the disposable fluid collection bladder disposed adjacent the axis of rotation. Centrifuge assembly.

59. 59. A centrifuge assembly according to any one of claims 56 to 58, The centrifuge assembly is part of an apheresis device. Centrifuge assembly.

60. 60. A centrifuge assembly according to any one of claims 56 to 59, the centrifuge housing is divided into an upper housing and a lower housing, the upper housing includes an internal cavity, the upper housing is rotatable between an open state and a closed state about a pivot axis offset from the rotation axis and substantially perpendicular to the rotation axis, and the fluid collection insertion channel of the fluid separation body is accessible in the open state and inaccessible in the closed state; Centrifuge assembly.

61. A blood component collection loop, comprising: A flexible loop; a system fixation loop connector disposed on a first end of the flexible loop, the system fixation loop connector being connected to a fixation loop connection of the centrifuge to secure the first end of the flexible loop for rotation therewith; a filler loop connector disposed at a second end of the flexible loop opposite the first end, the filler loop connector being connected to a loop connection region of a filler, such that a torsional force based on a twist in the flexible loop is applied to the filler via the filler loop connector; Equipped with the flexible loop is rotationally moved to be captured by a loop rotation positioning guide located on the centrifuge; Blood component collection loop.

62. 62. The blood component collection loop of claim 61, the blood component collection loop is part of a blood component collection set, the blood component collection set being associated with an apheresis system. Blood component collection loop.

63. 63. The blood component collection loop of claim 61 or 62, the loop rotation positioning guide is attached to a rotor that rotates the loop rotation positioning guide and the flexible loop about an axis of rotation; Blood component collection loop.

64. 64. The blood component collection loop according to claim 61, the blood component collection loop is at least partially positioned by a loop positioning stop plate; Blood component collection loop.

65. 65. The blood component collection loop according to claim 61, The flexible loop is curved around the centrifuge. Blood component collection loop.

66. 66. The blood component collection loop according to claim 61, The flexible loop is also held in place by a loop storage bracket. Blood component collection loop.

67. 67. The blood component collection loop according to claim 61, At least a portion of the loop rotation positioning guide comprises a loop torsion support bearing. Blood component collection loop.

68. 68. The blood component collection loop of claim 67, The loop torsion support bearing comprises a pair of roller bearings. Blood component collection loop.

69. 70. The blood component collection loop of claim 68, the loop torsion support bearing allows the flexible loop to twist; Blood component collection loop.

70. 70. The blood component collection loop of claim 69, the twisting causes the filler to rotate at a greater angular velocity than the centrifuge; Blood component collection loop.

71. 71. The blood component collection loop according to claim 61, the flexible loop may include two or more lumens for moving whole blood and / or blood components within the flexible loop; Blood component collection loop.

72. A first port; A second port; and a direct flow lumen fluidly connected to the first port and the second port; a drip chamber disposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber; a fluid flow bypass pathway fluidly connected to the direct flow lumen adjacent to the first port between the first port and the drip chamber and fluidly connected to the direct flow lumen adjacent to the second port between the second port and the drip chamber such that fluid flowing through the fluid flow bypass pathway bypasses the drip chamber; A soft cassette equipped with

73. 73. The soft cassette of claim 72, the fluid flow bypass pathway comprises a first bypass branch fluidly connected to the direct flow lumen adjacent to the first port, and a second bypass branch fluidly connected to the direct flow lumen adjacent to the second port. Soft cassette.

74. 74. The soft cassette of claim 73, the fluid flow bypass path further comprising a fluid pressure annulus disposed between and fluidly connected to the first bypass branch and the second bypass branch. Soft cassette.

75. 75. The soft cassette of claim 74, the direct flow lumen includes a first flexible region disposed between a first connection with the first bypass branch and the drip chamber, the first flexible region allowing a first fluid control valve to occlude the direct flow lumen; Soft cassette.

76. 76. The soft cassette of claim 75, the direct flow lumen includes a second flexible region disposed between a second connection with the second bypass branch and the drip chamber, the second flexible region allowing a second fluid control valve to occlude the direct flow lumen. Soft cassette.

77. 77. The soft cassette of claim 76, the direct flow lumen includes a third flexible region disposed within the first bypass branch, the third flexible region enabling a retraction fluid control valve to occlude the first bypass branch. Soft cassette.

78. 78. The soft cassette of claim 77, the first port is fluidly connected to a cassette inlet tube that transfers fluid from a donor to the soft cassette or from the soft cassette to the donor, and the second port is fluidly connected to a loop inlet tube that transfers fluid from the soft cassette to the centrifuge or from the centrifuge to the soft cassette. Soft cassette.

79. In the soft cassette according to any one of claims 72 to 78, when fluid is drawn from the donor, the fluid passes through the fluid flow bypass pathway; Soft cassette.

80. The soft cassette according to any one of claims 72 to 79, When delivering fluid to the donor, the fluid passes through the direct flow lumen. Soft cassette.

81. 81. The soft cassette of claim 80, when a next draw draws fluid from the donor, a portion of the fluid previously delivered to the donor through the direct flow lumen is retained in the drip chamber as the fluid passes through the fluid flow bypass path. Soft cassette.

82. In the soft cassette according to any one of claims 72 to 81, The soft cassette is part of a blood component collection set. Soft cassette.

83. 83. The soft cassette of claim 82, The blood component collection set is part of an apheresis system. Soft cassette.

84. A blood component collection set, the blood component collection set comprising: a centrifuge for separating blood components from whole blood; a cassette inlet tube fluidly connected to the donor; a loop inlet tube fluidly connected to the centrifuge; Soft cassette and Equipped with The soft cassette is a first cassette port fluidly connected to the cassette inlet tube; a second cassette port fluidly connected to the loop inlet tube; a direct flow lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber disposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber; a fluid flow bypass path fluidly connected to the direct flow lumen adjacent to the first cassette port between the first cassette port and the drip chamber and fluidly connected to the direct flow 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; Equipped with Blood component collection set.

85. 85. The blood component collection set of claim 84, The fluid flow bypass path includes: a first bypass branch fluidly connected to the direct flow lumen adjacent the first cassette port; a second bypass branch fluidly connected to the direct flow lumen adjacent the second cassette port; a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch; Equipped with Blood component collection set.

86. 86. The blood component collection set of claim 85, the direct flow lumen comprises a first flexible region disposed between a first connection with the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to occlude the direct flow lumen; the direct flow lumen comprises a second flexible region disposed between a second connection with the second bypass branch and the drip chamber, the second flexible region enabling a second fluid control valve to occlude the direct flow lumen; and the direct flow lumen comprises a third flexible region disposed within the first bypass branch, the third flexible region enabling a retract fluid control valve to occlude the first bypass branch. Blood component collection set.

87. 87. The blood component collection set of claim 86, When fluid is drawn from the donor, the first fluid control valve and the second fluid control valve are closed to occlude the direct flow lumen; the inlet fluid control valve opens to allow whole blood to pass through the fluid flow bypass pathway. Blood component collection set.

88. 88. The blood component collection set of claim 86 or 87, When delivering fluid to the donor, the first fluid control valve and the second fluid control valve are open to allow fluid to pass through the direct flow lumen; the retract fluid control valve is closed to block the fluid flow bypass path; Blood component collection set.

89. 89. The blood component collection set of claim 88, when fluid is drawn from the donor on a subsequent draw, a portion of the fluid previously delivered to the donor through the direct flow lumen is retained within the drip chamber as the fluid passes through the fluid flow bypass pathway. Blood component collection set.

90. 1. A method for moving a fluid through a soft cassette, the method comprising: A step of preparing 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 direct flow lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber interposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber; a fluid flow bypass path fluidly connected to the direct flow lumen adjacent to the first cassette port between the first cassette port and the drip chamber and fluidly connected to the direct flow 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; The method comprises the steps of: The method comprises: When whole blood is drawn from a donor, receiving whole blood from the cassette inlet tube at a first cassette port fluidly connected to the cassette inlet tube; transferring the whole blood through the fluid flow bypass path to the second cassette port; preventing whole blood from traveling through the direct flow lumen; having The method comprises: When red blood cells are returned to the donor, 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 direct flow lumen and the drip chamber to the first cassette port; preventing red blood cells from migrating through said fluid flow bypass pathway; having method.

91. 91. The method of claim 90, when fluid is drawn from the donor on a next draw, a portion of the fluid previously delivered to the donor through the direct flow lumen is retained in the drip chamber as whole blood again passes through the fluid flow bypass pathway when red blood cells are returned to the donor. method.

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