COMMUNICATIONS AND OPERATION CONTROL OF APHERESIS SYSTEMS

Description

COMMUNICATIONS AND OPERATION CONTROL OF APHERESIS SYSTEMS CROSS-REFERENCE TO RELATED REQUESTS

[0001] This application claims priority to U.S. Patent Application No. 18 / 116,988, filed March 3, 2023, which claims the benefit of U.S. Provisional Application No. 63 / 318,683, filed March 10, 2022. All disclosures of the above applications are incorporated herein by reference. FIELD

[0002] The present disclosure relates to the communication and operational control of apheresis systems. BACKGROUND

[0003] This section provides basic information relating to the present disclosure, which is not necessarily prior technical information.

[0004] There are two common methods for blood donation / collection. A first common method involves obtaining whole blood from a donor. After the whole blood is obtained, a centrifugation process can be used to separate the blood components from the whole blood, for example, based on the density of the different blood components. The desired components can be moved manually, semi-automatically, or automatically into a collection container during and / or after the application of centrifugal forces. A second common method may be called apheresis collection, which requires a specialized machine. For example, the apheresis method can extract whole blood from a donor while the donor is connected to the specialized apheresis machine.Whole blood can then be centrifuged to collect only the desired blood component(s) (e.g., plasma), returning all other blood components to the donor during the same donation connection or cycle. The donor is connected to the apheresis machine during the separation and collection of the blood component. Unfortunately, however... Petition 870250078665, dated 03 / 09 / 2025, page 17 / 393 2 / 274 The apheresis process can be lengthy and uncomfortable for the donor. For example, the donor often needs to remain connected to the specialized apheresis machine for an hour or more to obtain the blood component donation. Therefore, it would be desirable to develop processes and also improve the specialized apheresis machine to enhance the comfort and efficiency of the blood component donation procedure. SUMMARY

[0005] This section provides a general summary of the disclosure and is not a comprehensive disclosure of its entire scope or all of its features.

[0006] There is a need for a plasma or other blood component system that can reduce donation time and increase donor comfort. The embodiments presented in this document can increase the efficiency of the donation process by using the separated blood component to push or guide unwanted blood components back to the donor without stopping and restarting the centrifuge. For example, in at least one embodiment, the present disclosure provides methods and apparatus for positioning portions, including, for example, circuits, of disposables in medical devices. In at least one embodiment, the present development provides systems, including, for example, surfaces, for automatically guiding circuits. In at least one embodiment, the present disclosure provides medical devices, including, for example, blood separation machines, such as apheresis machines.

[0007] In at least one embodiment, the present disclosure provides an assembly for separating a component from a multicomponent fluid. The assembly may include a packing and a circuit rotational position guide. The packing may include a channel for retaining a separating bladder from a disposable one. The channel may include two opposing walls. The guide Petition 870250078665, dated 03 / 09 / 2025, p. 18 / 393 3 / 274 of a rotational positioning circuit may include a plurality of bearings. The rotational positioning circuit guide may retain a disposable flexible circuit when the separation bladder is loaded into the channel. In at least one embodiment, the rotational positioning circuit guide may include a stop plate. In at least one embodiment, the flexible circuit may contact the stop plate when retained in the rotational positioning circuit guide. In at least one embodiment, the assembly may be part of an apheresis machine. In at least one embodiment, the assembly may be connected to a rotor that rotates the rotational positioning circuit guide around an axis of rotation. In at least one embodiment, the plurality of bearings may include a plurality of roller bearing pairs.

[0008] In at least one embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include a centrifuge housing with an outer surface and an inner cavity. The centrifuge housing may rotate about an axis of rotation of the centrifuge assembly. The centrifuge assembly may include a fluid separation body disposed at least partially within an inner cavity of the centrifuge housing. The fluid separation body may be configured to rotate relative to the centrifuge housing about the axis of rotation of the centrifuge assembly. The centrifuge assembly may include a fluid line circuit arm connected to a portion of the centrifuge housing and running along a length of the outer surface of the centrifuge housing.The fluid line circuit arm may include a bearing assembly arranged at a point along the length of the outer surface, where the bearing assembly is configured to make contact with a portion of the tubing in a circuit. Petition 870250078665, dated 03 / 09 / 2025, page 19 / 393 4 / 274 of interconnected fluid line and maintain the fluid line circuit in an engaged position relative to the centrifuge housing, while allowing the fluid line circuit to rotate in the engaged position. In at least one embodiment, the bearing assembly may include a pair of roller bearings. In at least one embodiment, the bearing assembly may include a plurality of pairs of roller bearings. In at least one embodiment, the centrifuge assembly may be part of an apheresis machine.In at least one embodiment, the fluid line circuit may be attached to a non-rotating static portion of the apheresis machine at a first fluid line circuit end by means of a first positively located connector, and the fluid line circuit may be interconnected to the fluid separation body within the internal cavity at a second fluid line circuit end by means of a second positively located connector. In at least one embodiment, the second end of the fluid line circuit may rotate with the fluid separation body. In at least one embodiment, the fluid line circuit may be physically and fluidically connected to a disposable fluid separation bladder at the second positively located connector. In at least one embodiment, the fluid line circuit may include a plurality of lumens.In at least one embodiment, the fluid separation bladder may include a first flexible plate attached to a second flexible plate forming a fluid passage, where the first portion of the fluid passage may be narrow compared to the second portion of the fluid passage.

[0009] In at least one embodiment, the present disclosure provides a method for automatically charging a fluid line circuit in a centrifuge assembly. The Petition 870250078665, dated 03 / 09 / 2025, page 20 / 393 5 / 274 The method may include attaching the fluid line circuit 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 the rotation of the fluid separation body may cause the fluid line circuit to rotate relative to the housing and be guided into a channel of a circuit arm connected to a portion of the housing. The channel may include bearings arranged in a bearing assembly fixed to the circuit arm. The bearings may hold the fluid line circuit in a position relative to the housing while the centrifuge assembly rotates. In at least one embodiment, the bearings may contact a portion of the fluid line circuit while the fluid line circuit rotates within the channel relative to the housing.In at least one embodiment, the centrifuge housing may rotate in the first rotational direction at a first angular velocity about an axis of rotation, and the fluid separation body may rotate at a second, different angular velocity about the axis of rotation by means of a torsional force provided by the fluid line circuit. In at least one embodiment, the second angular velocity may be substantially twice the first angular velocity. In at least one embodiment, the fluid line circuit may be physically and fluidically connected to a disposable fluid separation bladder disposed at least partially within the fluid separation body.In at least one embodiment, the method may further include attaching a second end of the fluid line circuit to a fixed rotational point of an apheresis machine and rotating (e.g., by means of a rotor and motor assembly of the apheresis machine) the centrifuge assembly around the axis of rotation. Petition 870250078665, dated 03 / 09 / 2025, p. 21 / 393 6 / 274 in relation to the rotational fixed point of the apheresis machine.

[0010] In at least one embodiment, the present disclosure provides a method for collecting a blood component by means of apheresis. The method may include collecting whole blood from a donor into a centrifuge; spinning the centrifuge to cause centrifugal force to act on the whole blood to separate the whole blood into at least a first blood component and a third blood component; separating a first blood component from the whole blood; extracting the first blood component into a container; detecting when a second blood component is being extracted; and after the second blood component is detected and while the centrifuge continues to spin, forcing the separated first blood component back into the centrifuge to move at least the third blood component from the centrifuge and back to the donor.In at least one embodiment, the first blood component may include one or more of plasma, platelets, red blood cells, and / or high-hematocrit blood. In at least one embodiment, the second blood component may include one or more of plasma, platelets, red blood cells, and / or high-hematocrit blood. In at least one embodiment, the third blood component may include one or more of plasma, platelets, red blood cells, and / or high-hematocrit blood. In at least one embodiment, the first blood component may include two or more of plasma, platelets, red blood cells, and / or high-hematocrit blood. In at least one embodiment, the centrifuge may rotate at a first speed when separating the first blood component from the whole blood.In at least one embodiment, the centrifuge may continue spinning in first gear, forcing the first separated blood component back into the centrifuge. In at least one embodiment, the centrifuge may spin at a second speed. Petition 870250078665, dated 03 / 09 / 2025, p. 22 / 393 7 / 274 extract whole blood from the donor into the centrifuge. In at least one embodiment, the second speed may be slower than the first speed. In at least one embodiment, the first blood component may include blood separated from whole blood in a blood component collection set that is inserted into the centrifuge. In at least one embodiment, the centrifuge may include a fill that rotates a blood component collection bladder associated with the blood component collection set. In at least one embodiment, the blood component collection bladder may be inserted into a collection insertion channel formed in the fill to retain the blood component collection bladder.

[0011] In at least one embodiment, the present disclosure provides an apheresis system. The apheresis system may include a first tube having a lumen, fluidly associated with the needle, which moves whole blood from a donor through the lumen; an extraction pump coupled to the first tube that extracts whole blood from the donor into a centrifuge; the centrifuge that rotates to cause centrifugal force to act on the whole blood to separate the whole blood into at least one first blood component and a third blood component; a blood component collection bladder, inserted into the centrifuge and fluidically associated with the first tube, which separates the first blood component from the whole blood; a second tube, fluidically associated with the blood collection bladder, which moves the first blood component from the blood component collection bladder;a collection container, fluidly connected to the second tube, which extracts the first blood component from the apheresis system; a sensor positioned in physical proximity to the second tube to detect when a second blood component is being extracted from the whole blood; and after the second blood component is detected by the; Petition 870250078665, dated 03 / 09 / 2025, page 23 / 393 8 / 274 sensor and while the centrifuge continues to rotate, a return pump, coupled to the second tube, forces the first separated blood component back into the blood component collection bladder through the second tube to move at least the third blood component from the blood component collection bladder and back to the donor. In at least one embodiment, the first blood component may include plasma and the second blood component may include platelets, red blood cells, and / or high hematocrit blood. In at least one embodiment, the apheresis system may further include an anticoagulant pump configured to extract anticoagulant from an anticoagulant bag and mix the anticoagulant with whole blood in a collector or junction fluidically associated with the first tube. In at least one embodiment, the centrifuge may include a filler that rotates the blood component collection bladder.In at least one embodiment, the blood component collection bladder can be inserted into a collection insertion channel formed during filling to retain the blood component collection bladder.

[0012] In at least one embodiment, the present disclosure provides a blood component collection set associated with an apheresis system. The blood component collection set may include a needle inserted into a donor's blood vessel to collect whole blood from a donor; a first tube having a lumen, fluidly associated with the needle, which moves whole blood through the lumen, where a collection pump coupled to the first tube collects the donor's whole blood; a blood component collection bladder, inserted into a centrifuge and fluidly associated with the first tube, which separates the first blood component and a third component from the whole blood; a second tube, fluidly associated with the blood collection bladder, which Petition 870250078665, dated 03 / 09 / 2025, p. 24 / 393 9 / 274 moves the first blood component from the blood component collection bladder; and a collection vessel fluidly associated with the second tube that extracts the first blood component from the apheresis system, where a sensor is positioned in physical proximity to the second tube to detect when a second blood component is being extracted from the whole blood; and where, after the second blood component is detected by the sensor and while the centrifuge continues to rotate, a return pump coupled to the second tube forces the separated first blood component back into the blood component collection bladder through the second tube to move at least the third blood component from the blood component collection bladder and back to the donor. In at least one embodiment, the first blood component may include plasma and the second blood component may include platelets.In at least one embodiment, the extraction pump can be disengaged when the return pump forces the first separated blood component back into the blood component collection bladder through the second tube to move at least the third blood component from the blood component collection bladder and back to the donor. In at least one embodiment, the blood component collection bladder can be inserted and retained in a packing material in the centrifuge, which rotates the blood component collection bladder. In at least one embodiment, the blood component collection bladder can be inserted into a collection insertion channel formed in the packing material to retain the blood component collection bladder.

[0013] In at least one embodiment, the present disclosure provides a filling configured to retain a separation bladder in which a component is separated from a composite fluid. The filling may include a channel to retain a separation bladder during the separation of the component from the fluid. Petition 870250078665, dated 03 / 09 / 2025, page 25 / 393 10 / 274 composite. The channel may include a first wall and a second wall opposite the first wall. A first end of the channel may be adjacent to a central portion of the filling, and the channel spirals toward an outer perimeter of the filling. In at least one embodiment, an upper portion of the channel may be narrower than an intermediate portion of the channel. In at least one embodiment, at least a portion of the second wall may have a concave surface. In at least one embodiment, the second end of the channel may be located so that it experiences a greater gravitational force during separation than the first end. In at least one embodiment, the upper portion of the channel may provide reinforcement to the separation bladder during separation.

[0014] In at least one embodiment, the present disclosure provides a fluid separation fill. The fluid separation fill may include a body having a rotation axis substantially disposed at a center of mass of the body and a fluid collection insertion channel disposed in the body and following a substantially spiral path that goes from a first point adjacent to the rotation axis spiraling outward to a second point disposed adjacent to a periphery of the body. The fluid collection insertion channel may move outward toward the periphery of the body near an end of the substantially spiral path that defines a third point of the fluid collection insertion channel disposed further from the rotation axis.In at least one embodiment, the fluid separation packing may further include a fluid collection chamber disposed within the body and following a substantially spiral portion of the path, where the fluid collection insertion channel connects to the fluid collection chamber, defining the access area between an interior of the fluid collection chamber and an exterior of the body. Petition 870250078665, dated 03 / 09 / 2025, page 26 / 393 11 / 274 body. In at least one embodiment, the fluid collection chamber may be configured to receive a disposable fluid collection bladder. In at least one embodiment, a dimension of the axis of rotation to the third point of the substantially spiral path may be larger than a dimension of the axis of rotation to the second point of the substantially spiral path. In at least one embodiment, a width of the fluid collection chamber at a point along the substantially spiral path may be larger than a width of the fluid collection insertion channel at that point along the substantially spiral path. In at least one embodiment, the fluid collection chamber may further include a first wall following an innermost portion of the substantially spiral path and a second wall substantially parallel to the first wall and following an outermost portion of the substantially spiral path.In at least one embodiment, the fluid collection chamber may further include one or more conical walls disposed between the first wall and the second wall, and one or more conical walls may be configured to guide the disposable fluid collection bladder into a seated position within the fluid collection chamber.In at least one embodiment, a fluid inlet for the disposable fluid collection bladder, when installed in the fluid collection chamber, may be arranged adjacent to the axis of rotation, and a first fluid path in the disposable fluid collection bladder may follow a substantially spiral path outward toward one end of the disposable fluid collection bladder arranged adjacent to the third point of the fluid collection insertion channel arranged furthest from the axis of rotation, and may fluidically interconnect with a second fluid path separate from the first fluid path in the disposable fluid collection bladder that runs in a direction toward the third point. Petition 870250078665, dated 03 / 09 / 2025, page 27 / 393 12 / 274 following the substantially spiral path inward toward a fluid outlet to the disposable fluid collection bladder disposed adjacent to the axis of rotation. In at least one embodiment, the fluid inlet and fluid outlet may be part of a connector connected to the disposable fluid collection bladder, and the fluid separation packing body may include a connection point that engages with the connector. In at least one embodiment, the connector may include at least one key feature, where the connection point may include at least one key coupling feature, and the key features may positively locate the connector relative to the connection point.

[0015] In at least one embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include a centrifuge housing having an internal cavity, wherein the centrifuge housing rotates about an axis of rotation of the centrifuge assembly, and a fluid separation body disposed at least partially within the internal cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the axis of rotation. The fluid separation body may include a fluid collection insertion channel disposed in the fluid separation body following a substantially spiral path that goes from a first point adjacent to the axis of rotation spiraling outward to a second point disposed adjacent to a periphery of the fluid separation body.The fluid collection insertion channel may, in at least one exemplary embodiment, the fluid separation body may further include a fluid collection chamber disposed within the body and following a substantially spiral portion of the path, where the fluid collection insertion channel may connect to the fluid collection chamber to define an access area between the interior of the fluid collection chamber and a... Petition 870250078665, dated 03 / 09 / 2025, page 28 / 393 13 / 274 exterior of the fluid separation body. In at least one embodiment, the centrifuge assembly may further include a disposable fluid collection bladder disposed within the fluid collection chamber following a substantially spiral path.The disposable fluid collection bladder may include a fluid inlet disposed adjacent to the axis of rotation, and a first fluid path in the disposable fluid collection bladder may follow a substantially spiral path outward toward an end of the disposable fluid collection bladder disposed adjacent to the third point of the fluid collection insertion channel disposed furthest from the axis of rotation, and may fluidically interconnect with a second fluid path separate from the first fluid path in the disposable fluid collection bladder that runs in a direction from the third point following a substantially spiral path inward toward a fluid outlet to the disposable fluid collection bladder disposed adjacent to the axis of rotation. In at least one embodiment, the centrifuge assembly may be part of an apheresis machine.In at least one embodiment, the centrifuge housing can be divided into an upper housing and a lower housing, where the upper housing may include the internal cavity, the upper housing may be rotatable between an open state and a closed state around a hinge axis that is offset and substantially perpendicular to the axis of rotation, and the fluid collection insertion channel of the fluid separation body may be accessible in the open state and inaccessible in the closed state.

[0016] In at least one embodiment, the present disclosure provides a blood component collection circuit. The blood component collection circuit may include a flexible circuit; a static system circuit connector disposed at one end of the circuit. Petition 870250078665, dated 03 / 09 / 2025, p. 29 / 393 14 / 274 flexible, where the static circuit connector of the system is connected to the fixed circuit connection of a centrifuge to secure the first end of the flexible circuit to rotate in unison with the centrifuge; and a filling circuit connector disposed at a second end, opposite the first end, of the flexible circuit, where the filling circuit connector is connected to a circuit connection area of ​​a filler, where torsional forces based on the torsion in the flexible circuit are transmitted to the filler through the filling circuit connector, and where the flexible circuit is moved rotationally to be captured by a rotational position guide of the circuit positioned in the centrifuge. In at least one embodiment, the blood component collection circuit may be part of a blood component collection assembly, and the blood component collection assembly may be associated with an apheresis system.In at least one embodiment, the circuit rotational position guide may be attached to a rotor that rotates the circuit rotational position guide and the flexible circuit around an axis of rotation. In at least one embodiment, the blood component collection circuit may be positioned at least partially by a circuit position stop plate. In at least one embodiment, the flexible circuit may be curved around the centrifuge. In at least one embodiment, the flexible circuits may also be retained in position by a circuit containment support. In at least one embodiment, at least a portion of the circuit rotational position guide may include a circuit torsion support bearing. In at least one embodiment, the circuit torsion support bearing may include a pair of roller bearings.In at least one embodiment, the circuit torsion support bearing may allow the flexible circuit to twist. In at least... Petition 870250078665, dated 03 / 09 / 2025, p. 30 / 393 15 / 274 except for one example of a modality, torsion can cause the filling to rotate at a greater angular velocity than the centrifuge. In at least one example of a modality, the flexible circuit may include two or more lumens to move whole blood and / or blood components within the flexible circuit.

[0017] In at least one embodiment, the present disclosure provides an assembly for carrying a flexible circuit. The assembly may include a circuit rotation position guide comprising a channel for retaining a flexible circuit from a blood component collection assembly; a circuit torsion support bearing, disposed in the channel and in a portion of the circuit rotation position guide, to support the flexible circuit; and a circuit capture arm, wherein the circuit capture arm may be positioned adjacent to the channel and connected to the circuit rotation position guide, to guide the flexible circuit into the channel and into contact with the circuit torsion support bearing.In at least one embodiment, the assembly may be part of an apheresis machine, and the circuit rotation position guide may be connected to a centrifuge that rotates the circuit rotation position guide and the flexible circuit around an axis of rotation. In at least one embodiment, the circuit rotation position guide may further include a circuit position stop plate to further position the flexible circuit. In at least one embodiment, the assembly may further include a circuit containment support, positioned in a plane with the circuit rotation position guide and disposed in the centrifuge, to further capture the flexible circuit.

[0018] In at least one embodiment, the present disclosure provides a method for automatically loading a flexible circuit into an assembly. The method may include connecting a static system circuit connector, arranged in a Petition 870250078665, dated 03 / 09 / 2025, p. 31 / 393 16 / 274 first end of the flexible circuit, to a fixed circuit connection of a centrifuge to secure the first end of the flexible circuit to rotate in unison with the centrifuge; connect a filling circuit connector, disposed at a second end, opposite the first end, of the flexible circuit, to a circuit connection area of ​​a filling, where torsional forces based on the torsion in the flexible circuit are transmitted to the filling through the filling circuit connector; and rotationally move the flexible circuit to a circuit rotational position guide positioned in the centrifuge. In at least one embodiment, the flexible circuit may engage a circuit torsion support bearing, disposed in a channel formed by the circuit rotational position guide, where the circuit torsion support bearing supports the flexible circuit.In at least one embodiment, a circuit capture arm may contact the flexible circuit as it rotates to guide the flexible circuit into the channel and contact the circuit torsion support bearing. In at least one embodiment, the circuit rotation position guide may further include a circuit position stop plate to prevent excessive rotation of the flexible circuit beyond the channel. In at least one embodiment, a circuit containment support, positioned in a plane with the circuit rotation position guide and disposed in the centrifuge, may further capture and retain the flexible circuit.

[0019] In at least one embodiment, the present disclosure provides a soft cassette. The soft cassette may include a first cassette port, a second cassette port, a direct flow lumen fluidically connected to the first cassette port and the second cassette port, a drip chamber interspersed within the direct flow lumen. Petition 870250078665, dated 03 / 09 / 2025, page 32 / 393 17 / 274 such that the fluid passing through the direct flow lumen passes through the drip chamber and a fluid flow diversion path fluidically connected to the direct flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber and fluidically connected to the direct flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber, such that the fluid flowing through the fluid flow diversion path is diverted from the drip chamber. In at least one embodiment, the fluid flow diversion path may include a first diversion branch fluidically connected to the direct flow lumen adjacent to the first cassette port and a second diversion branch fluidically connected to the direct flow lumen adjacent to the second cassette port.In at least one embodiment, the fluid flow diversion path may further include a fluid pressure ring disposed between and fluidly connected to the first diversion branch and the second diversion branch. In at least one embodiment, the direct flow lumen may include a first compliant region, disposed between a first connection to the first diversion branch and the drip chamber, which allows a first fluid control valve to occlude the direct flow lumen. In at least one embodiment, the direct flow lumen may include a second compliant region, disposed between a second connection to the second diversion branch and the drip chamber, which allows a second fluid control valve to occlude the direct flow lumen.In at least one embodiment, the direct flow lumen may include a third compliant region, disposed in the first bypass branch, which allows an extraction fluid control valve to occlude the first bypass branch. In at least one embodiment, the first cassette port may be fluidly connected to a cassette inlet pipe that moves fluid. Petition 870250078665, dated 03 / 09 / 2025, page 33 / 393 18 / 274 from a donor to the soft cassette or fluid from the soft cassette to the donor, and the second cassette port may be fluidly connected to a circuit inlet tubing that moves fluid from a soft cassette to the centrifuge or fluid from the centrifuge to the soft cassette. In at least one embodiment, when extracting fluid from the donor, the fluid may pass through the fluid flow bypass path. In at least one embodiment, when sending fluid to the donor, the fluid may pass through the direct flow lumen. In at least one embodiment, when extracting fluid from the donor in a subsequent extraction, a portion of the fluid previously sent to the donor through the direct flow lumen may be retained in the drip chamber when the fluid passes through the fluid flow bypass path. In at least one embodiment, the flexible cassette may be part of a blood component collection assembly.In at least one exemplary embodiment, the blood component collection set may be part of an apheresis system.

[0020] In at least one embodiment, the present disclosure provides a blood component collection assembly. The blood component collection assembly may include a centrifuge for separating blood components from whole blood; a cassette inlet tubing fluidically connected to a donor; a circuit inlet tubing fluidically connected to the centrifuge; a flexible cassette including a first cassette port fluidically connected to the cassette inlet tubing; a second cassette port fluidically connected to the circuit inlet tubing; a direct flow lumen fluidically connected to the first cassette port and the second cassette port; a drip chamber interleaved in the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber; and a fluid flow bypass path. Petition 870250078665, dated 03 / 09 / 2025, page 34 / 393 19 / 274 fluidly connected to the direct flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber, and fluidly connected to the direct flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber, such that the fluid flowing through the fluid flow diversion path is diverted from the drip chamber. In at least one embodiment, the fluid flow diversion path may include a first diversion branch fluidly connected to the direct flow lumen adjacent to the first cassette port, a second diversion branch fluidly connected to the direct flow lumen adjacent to the second cassette port, and a fluid pressure ring disposed between and fluidly connected to the first diversion branch and the second diversion branch.In at least one embodiment, the direct flow lumen may include a first compliant region, disposed between a first connection with the first bypass branch and the drip chamber, which allows a first fluid control valve to occlude the direct flow lumen, where the direct flow lumen includes a second compliant region, disposed between a second connection with the second bypass branch and the drip chamber, which allows a second fluid control valve to occlude the direct flow lumen, and where the direct flow lumen includes a third compliant region, disposed in the first bypass branch, which allows an extraction fluid control valve to occlude the first bypass branch.In at least one embodiment, when extracting fluid from the donor, the first fluid control valve and the second fluid flow control valve may be closed, obstructing the direct flow lumen, and the extraction fluid control valve may be opened, allowing whole blood to pass through the fluid flow bypass path. In at least one embodiment, when sending fluid to the donor, the first fluid control valve and the second... Petition 870250078665, dated 03 / 09 / 2025, page 35 / 393 20 / 274 fluid flow control valves can be opened to allow fluid to pass through the direct flow lumen, and the extraction fluid control valve can be closed to obstruct the fluid flow bypass path. In at least one embodiment, when extracting fluid from the donor in a subsequent extraction, a portion of the fluid previously sent to the donor through the direct flow lumen can be retained in the drip chamber when the fluid passes through the fluid flow bypass path.

[0021] In at least one embodiment, the present disclosure provides a method for moving fluids through a soft cassette.The method may include providing a soft cassette, wherein the soft cassette includes a first cassette port fluidly connected to a cassette inlet pipe, a second cassette port fluidly connected to a circuit inlet pipe, a direct flow lumen fluidly connected to the first cassette port and to the second cassette port, a drip chamber interleaved in the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber and fluidly connected to the direct flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.In at least one embodiment, the method may include, when collecting whole blood from a donor, receiving whole blood from the cassette inlet tubing into a first cassette port fluidically connected to the cassette inlet tubing, moving the whole blood through the fluid flow bypass path to the second cassette port, and preventing the whole blood from entering. Petition 870250078665, dated 03 / 09 / 2025, page 36 / 393 21 / 274 move through the direct lumen. In at least one embodiment, the method may include, upon returning the red blood cells to the donor, receiving the red blood cells from the circuit inlet tubing into a second cassette port fluidically connected to the circuit inlet tubing, moving the red blood cells through the direct flow lumen and drip chamber to the first cassette port, and preventing the red blood cells from moving through the fluid flow bypass path. In at least one embodiment, upon withdrawing fluid from the donor in a subsequent collection, a portion of the fluid may be previously sent to the donor through the direct flow lumen, and upon returning red blood cells to the donor.

[0022] In at least one embodiment, the present disclosure includes a method. The method includes detecting the initialization of an apheresis machine; in response to the initialization detection, transmitting data to a server; determining, based on the data, whether the apheresis machine software is up-to-date; receiving, in response to the data, a response from the server; and preventing the use of the apheresis machine if the response indicates that the software is not up-to-date.

[0023] In at least one embodiment, the data transmitted to the server includes one or more data records, a firmware version identifier, and an error log.

[0024] In at least one example of a modality, the response includes a blocking signal.

[0025] In at least one example of modality, the response includes a software update.

[0026] In at least one embodiment, the software update includes a firmware update.

[0027] In at least one embodiment example, the method includes automatically initiating the installation of the software update. Petition 870250078665, dated 03 / 09 / 2025, page 37 / 393 22 / 274

[0028] In at least one embodiment, the method includes ceasing the prevention of the use of the apheresis machine after the software update is installed.

[0029] In at least one embodiment example, the method includes manually initiating the software update installation.

[0030] In at least one example of the mode, the method includes, based on the server response, displaying a message in a graphical user interface.

[0031] In at least one embodiment, the graphical user interface allows a user to initiate a software installation.

[0032] In at least one embodiment, the method includes, after preventing the use of the apheresis machine, determining that an unlocking requirement has been met and, in response to the determination that the unlocking requirement has been met, enabling the use of the apheresis machine.

[0033] In at least one example of the modality, the unlocking requirement is associated with updated software.

[0034] In at least one embodiment, the software includes one or more firmware, applications, and operating systems.

[0035] In at least one embodiment, the method includes the manual installation of a software update.

[0036] In at least one embodiment, the manual installation of the software update includes connecting an external device, including the software update, to the apheresis machine and installing the software update.

[0037] The present disclosure provides a number of advantages depending on the specific aspect, modality and / or configuration. For example, in at least one example embodiment, by the centrifuge rotation speed when moving unnecessary blood components back to the donor, the apheresis procedure time can be reduced, for example, by about Petition 870250078665, dated 03 / 09 / 2025, pages 38 / 393 23 / 274 30% or more. This increase in efficiency can allow for faster and more convenient donations. With faster donation times, a donation center can obtain more donations in a typical day, which can increase productivity and revenue. Furthermore, donors are more likely to donate again if the donation process is faster. Having faster donations can also allow donation centers to attract donors using other donation centers with slower donation speeds.

[0038] Other areas of applicability will become apparent from the description provided in this document. The description and specific examples in this summary are for illustrative purposes only and are not intended to limit the scope of this disclosure. DESIGNS

[0039] The drawings described in this document are for illustrative purposes only of selected embodiments and not of all possible implementations and are not intended to limit the scope of this disclosure.

[0040] FIG. 1 shows a perspective view of an operating environment of an apheresis system according to at least one exemplary embodiment of the present disclosure. FIG. 2A is a perspective view of the apheresis system shown in FIG. 1; FIG. 2B is a first detailed perspective view of a pump of an apheresis system according to at least one exemplary embodiment of the present disclosure; FIG. 2C is a second detailed perspective view of a pump of an apheresis system according to at least one exemplary embodiment of the present disclosure; FIG. 2D is a detailed perspective view of a fluid valve control system according to at least one exemplary embodiment of the present disclosure; FIG. 3A is a detailed perspective view of an assembly. Petition 870250078665, dated 03 / 09 / 2025, pp. 39 / 393 24 / 274 disposable soft cassette according to at least one embodiment of this disclosure; FIG. 3B is a perspective view of a disposable soft cassette according to at least one embodiment of the present disclosure; FIG. 3C is an elevation section view taken through line 3C of FIG. 3B according to at least one embodiment of this disclosure; FIG. 3D is an elevation section view taken through the 3D line of FIG. 3B according to at least one embodiment of this disclosure; FIG. 4A shows a perspective view of a centrifuge assembly in an apheresis system according to at least one exemplary embodiment of the present disclosure; FIG. 4B shows a front perspective view of the centrifuge assembly shown in FIG. 4A; FIG. 4C shows a rear perspective view of the centrifuge assembly shown in FIG. 4A; FIG. 4D is a schematic cross-sectional view of a closed-state centrifuge assembly according to at least one exemplary embodiment of the present disclosure; FIG. 4E is a schematic cross-sectional view of a centrifuge assembly in a partially open state according to at least one exemplary embodiment of the present disclosure; FIG. 4F is a schematic cross-sectional view of an open-state centrifuge assembly according to at least one exemplary embodiment of the present disclosure; FIG. 4G shows a perspective view of a filling for a centrifuge according to at least one exemplary embodiment of the present disclosure; FIG. 4H is a plan view of a packing for a centrifuge according to at least one embodiment of this disclosure; Petition 870250078665, dated 03 / 09 / 2025, p. 40 / 393 25 / 274 FIG. 4I is a schematic plan view of a receiving channel substantially in spiral shape for filling according to at least one exemplary embodiment of this disclosure; FIG. 4J is an elevation section view taken through line 4J of FIG. 4H; FIG. 4K is a detailed sectional view of a portion of a channel in the filling according to at least one exemplary embodiment of the present disclosure; FIG. 4L shows different states of fluid collection bladders arranged within the channel during filling in FIG. 4K; FIG. 5A is an illustration of a fluid component collection assembly including a fluid component collection circuit according to at least one exemplary embodiment of the present disclosure; FIG. 5B is an illustration of the fluid component collection circuit that includes a fluid component collection bladder according to at least one exemplary embodiment of the present disclosure; FIG. 5C is a cross-sectional illustration of the fluid component collection bladder according to at least one exemplary embodiment of the present disclosure; FIG. 5D is another cross-sectional illustration of the fluid component collection bladder according to at least one exemplary embodiment of the present disclosure; FIG. 5E shows a perspective view of a fluid component collection circuit in a flexed state according to at least one exemplary embodiment of the present disclosure; FIG. 5F shows a perspective view of a fluid component collection circuit in a loaded state according to at least one exemplary embodiment of the present disclosure; FIG. 5G shows a perspective view of a circuit of Petition 870250078665, dated 03 / 09 / 2025, page 41 / 393 26 / 274 collection of fluid components loaded into a filler according to at least one example embodiment of the present disclosure; FIG. 5H shows a perspective view of a fluid component collection circuit loaded into a packing according to at least one exemplary embodiment of the present disclosure; FIG. 6A shows a schematic cross-sectional view of a centrifuge assembly in a first circuit loading state, according to at least one exemplary embodiment of the present disclosure; FIG. 6B shows a schematic cross-sectional view of a centrifuge assembly in a second circuit loading state according to at least one embodiment of the present disclosure; FIG. 6C shows a schematic sectional view of a centrifuge assembly in a third circuit loading state, according to at least one exemplary embodiment of the present disclosure; FIG. 7A shows a schematic plan view of a centrifuge assembly in a loaded circuit state, according to at least one embodiment of the present disclosure; FIG. 7B shows a schematic plan view of a centrifuge assembly in an operational state according to at least one exemplary embodiment of the present disclosure; FIG. 8 is a functional diagram of a modality of the apheresis system according to at least one example modality of this disclosure; FIG. 9 is a block diagram of the electrical system of the apheresis system according to at least one embodiment of an example of this disclosure; FIG. 10 is an additional block diagram of the electrical system of the apheresis system according to at least one embodiment of Petition 870250078665, dated 03 / 09 / 2025, p. 42 / 393 27 / 274 example of this disclosure; FIG. 11 is an additional block diagram of the electrical system of the apheresis system according to at least one example embodiment of the present disclosure; FIG. 12A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure; FIG. 12B shows an apheresis system with a scanner according to at least one exemplary embodiment of the present disclosure; FIG. 12C shows a bottle according to at least one embodiment of the present disclosure; FIG. 12D shows a graphical user interface according to at least one embodiment of the present disclosure; FIG. 13A is an isometric view of a plasma collection bottle retainer according to at least one exemplary embodiment of the present disclosure; FIG. 13B is a flowchart according to at least one embodiment of the present disclosure; FIG. 14A is a perspective view of a movable circuit retainer of an apheresis system according to at least one embodiment of the present disclosure; FIG. 14B is a partial view of the moving circuit retainer illustrated in FIG. 14A; FIG. 14C is a cross-sectional elevation view along line 14C illustrated in FIG. 14B; FIG. 14D is a partial view of the movable circuit retainer in an extended position according to at least one embodiment of the present disclosure; FIG. 14E is a partial view of the movable circuit retainer in a retracted position according to at least one embodiment of the present disclosure; FIG. 14F is a partial view of the movable circuit retainer in the retracted position and the cover of a centrifuge assembly in the Petition 870250078665, dated 03 / 09 / 2025, p. 43 / 393 28 / 274 apheresis system is in an open position according to at least one embodiment of the example of the present disclosure; FIG. 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment of the present disclosure; FIG. 15B is an exploded perspective view of the load cell assembly of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15C is a top perspective view of a mounting plate for the load cell assembly of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15D is a bottom perspective view of the mounting plate of FIG. 15C according to at least one exemplary embodiment of this disclosure; FIG. 15E is a perspective view of a load cell assembly support of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15F is a perspective view of a load cell from the load cell assembly of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15G is a perspective view of a load interface plate of the load cell assembly of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15H is a perspective view of an overload support bar of the load cell assembly of FIG. 15A according to at least one embodiment of this disclosure; FIG. 15I is a partial sectional view of the load cell assembly of FIG. 15A in an engaged state according to at least one exemplary embodiment of this disclosure; FIG. 15J is a partial sectional view of the load cell assembly of FIG. 15A in a disengaged state, with a portion of a first magnet cut off, according to at least one embodiment. Petition 870250078665, dated 03 / 09 / 2025, page 44 / 393 29 / 274 example of this disclosure; FIG. 15K is a side elevation view of a cradle of the load cell assembly of FIG. 15A according to at least one embodiment of the present disclosure; FIG. 15L is a front elevation view of the cradle in FIG. 15K according to at least one embodiment of the present disclosure; FIG. 15M is a perspective view of a vase in the cradle of FIG. 15K according to at least one embodiment of the present disclosure; FIG. 16A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure; FIG. 16B shows an apheresis system connected to a network according to at least one embodiment of the example of the present disclosure; FIG. 16C shows a graphical user interface according to at least one embodiment of the present disclosure; FIG. 16D is a block diagram of a computer system according to at least one embodiment of an example of the present disclosure; FIG. 17A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure; FIG. 17B shows an apheresis system according to at least one embodiment of the example of the present disclosure; FIGS. 17C-17E show output devices according to at least one example embodiment of the present disclosure; FIG. 18A is a partially exploded perspective view of an apheresis system including modular maintenance sleds according to at least one exemplary embodiment of this disclosure; FIG. 18B is a schematic elevation section view of a modular maintenance sled in a disengaged state from an apheresis system base according to at least one embodiment of Petition 870250078665, dated 03 / 09 / 2025, p. 45 / 393 30 / 274 example of this disclosure; FIG. 18C is a bottom perspective view of a return pump assembly of the apheresis system of FIG. 18A according to at least one embodiment of this disclosure; FIG. 18D is a schematic elevation section view of the modular maintenance sled of FIG. 18C in a state engaged with the base of the apheresis system according to at least one exemplary embodiment of the present disclosure; FIG. 18E is a flowchart illustrating a method for maintaining an apheresis system according to at least one embodiment of the example in this disclosure; FIG. 19A is a perspective view of a collection bottle according to at least one exemplary embodiment of the present disclosure; FIG. 19B is an elevated view of the collection bottle of FIG. 19A oriented in a plasma collection cradle of the apheresis system according to at least one exemplary embodiment of the present disclosure; FIG. 19C is a perspective view of the canister of the collection bottle in FIG. 19A; FIG. 19D is a top-down perspective view of the lid of the collection bottle in FIG. 19A; FIG. 19E is a bottom-up view of the lid of the collection vial in FIG. 19A; FIG. 19F is a partial cross-sectional view of the collection vial of FIG. 19A before collection (i.e., before use) according to at least one embodiment of the present disclosure; FIG. 19G is a partial view of the collection vial of FIG. 19A after collection (i.e., after use) according to at least one embodiment of the present disclosure; FIG. 19H is an elevation view of a transport package of collection bottles including several rows of bottles. Petition 870250078665, dated 03 / 09 / 2025, page 46 / 393 31 / 274 full collection (i.e., after collection) according to at least one example of a mode of this disclosure; FIG. 19I is a side view of the collection bottle of FIG. 19A arranged in a collection cradle according to at least one exemplary embodiment of the present disclosure; FIG. 19J is a perspective view of the collection bottle from FIG. 19A positioned in the collection cradle; FIG. 20 is a flowchart of a method according to at least one exemplary embodiment of the present disclosure; FIG. 21A is a partial perspective view of the apheresis system of FIG. 18A according to at least one embodiment of this disclosure; FIG. 21B is an elevation view of a first set of hangers of the apheresis system of FIG. 21A according to at least one embodiment of this disclosure; FIG. 21C is an exploded perspective view of the first set of hangers in FIG. 21B according to at least one embodiment of this disclosure; FIG. 21D is an elevation view of a second hanger assembly of the apheresis system of FIG. 21A according to at least one embodiment of this disclosure; FIG. 21E is an exploded perspective view of the second coat hanger set of FIG. 21D according to at least one embodiment of this disclosure; FIG. 21F is a perspective view of an air assembly of the apheresis system of FIG. 21A according to at least one embodiment of this disclosure; FIG. 21G is a partial perspective view of a centrifuge housing of the apheresis system of FIG. 21A according to at least one embodiment. FIG. 21H is a perspective view of a centrifuge assembly of the apheresis system of FIG. 21A in a cover lock state according to at least one embodiment of Petition 870250078665, dated 03 / 09 / 2025, p. 47 / 393 32 / 274 example of this disclosure; FIG. 21I is a partial exploded perspective view of a locking engagement plate and a centrifuge locking assembly of FIG. 21H according to at least one embodiment of the present disclosure; FIG. 21J is a perspective view of a cover coupling plate of the centrifuge assembly of FIG. 21H according to at least one embodiment of the present disclosure; FIG. 21K is a perspective view of a cover for the centrifuge assembly of FIG. 21H according to at least one embodiment of the present disclosure; FIG. 21L is a perspective view of a base of the centrifuge assembly of FIG. 21H according to at least one embodiment of the present disclosure; FIG. 21M is a partial bottom perspective view of the centrifuge assembly of FIG. 21H in the locked state according to at least one exemplary embodiment of the present disclosure; FIG. 21N is a partial bottom perspective view of the centrifuge assembly of FIG. 21M in the unlocked state according to at least one exemplary embodiment of this disclosure; FIG. 21O is a perspective view of the compressor assembly of FIG. 21H in a cover unlock status according to at least one example embodiment of this disclosure; FIG. 22A is a flowchart of a method according to at least one exemplary embodiment of this disclosure; FIG. 22B is a flowchart of a method according to at least one embodiment of an example of this disclosure; FIG. 22C shows a centrifuge chamber according to at least one exemplary embodiment of this disclosure; FIG. 23A is an elevation sectional view of a bend-based pipe status sensor according to at least one exemplary embodiment of the present disclosure; FIG. 23B is a perspective view of the bending block of Petition 870250078665, dated 03 / 09 / 2025, page 48 / 393 33 / 274 pipe bend-based condition sensor from FIG. 23A; FIG. 23C is a schematic diagram of an exaggerated displacement of the bending block when pressure is applied to a section of pipe engaged with the bending block of FIG. 23B; FIG. 23D is a perspective view of another example of the bending block of the bending-based pipe status sensor according to at least one embodiment of the present disclosure; FIG. 24A is an elevation view of the blood component collection circuit of FIG. 5A according to examples in this disclosure; FIG. 24B is an elevation view of the blood component collection circuit of FIG. 24A in a first folded state according to at least one example embodiment; FIG. 24C is an elevation view of the blood component collection circuit of FIG. 24A in a second folded state according to at least one exemplary embodiment; FIG. 24D is an elevation view of the blood component collection circuit of FIG. 24A in a third state folded according to at least one exemplary embodiment; FIG. 24E is a bottom plan view of the blood component collection circuit with a folded and packaged bladder according to at least one exemplary embodiment of the present disclosure; FIG. 24F is a perspective view of the blood component collection assembly of FIG. 5A according to at least one embodiment; FIG. 24G is a perspective view of the blood component collection circuit of FIG. 24F without sealing tape wrapping according to at least one embodiment; FIG. 24H is a top plan view of the blood component collection circuit of FIG. 24A according to at least one embodiment; Petition 870250078665, dated 03 / 09 / 2025, page 49 / 393 34 / 274 FIG. 24I is a perspective view of a filling of the centrifuge assembly of FIG. 4B according to at least one embodiment of the present disclosure; FIG. 24J is a detailed schematic view of a section of a collection insertion channel of the centrifuge assembly of FIG. 24I according to at least one embodiment; FIG. 25A is a perspective view of another soft cassette according to at least one exemplary embodiment of the present disclosure; FIG. 25B is a side elevation view of the soft cassette of FIG. 25A according to at least one exemplary embodiment of the present disclosure; FIG. 25C is a front elevation view of the soft cassette of FIG. 25A according to at least one exemplary embodiment of the present disclosure; FIG. 25D is a schematic sectional view of a flexible cassette assembly, including the flexible cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure; FIG. 25E is a perspective view of the soft cassette assembly of FIG. 25D in an open state according to at least one exemplary embodiment of the present disclosure; FIG. 25F is a partial sectional view of the soft cassette of FIG. 25A in a first pressure state according to at least one exemplary embodiment of the present disclosure; FIG. 25G is a partial sectional view of the soft cassette of FIG. 25A in a second pressure state according to at least one exemplary embodiment of the present disclosure; FIG. 25H is an exploded view of the soft cassette of FIG. 25A according to at least one exemplary embodiment of this disclosure; FIG. 25I is another exploded view of the soft cassette of FIG. 25A according to at least one exemplary embodiment of Petition 870250078665, dated 03 / 09 / 2025, p. 50 / 393 35 / 274 present disclosure; FIG. 25J is a flowchart describing a method for manufacturing the soft cassette of FIG. 25A according to at least one exemplary embodiment of this disclosure; FIG. 25K is a partial sectional view of the soft cassette of FIG. 25A showing a valve region according to at least one exemplary embodiment of the present disclosure. FIG. 25L is a detailed sectional view of the valve region of FIG. 25K according to at least one embodiment of the present disclosure; FIG. 25M is a schematic view of another soft cassette according to at least one exemplary embodiment of this disclosure; FIG. 26A is a perspective view of a separation assembly in a packaged state according to at least one exemplary embodiment of the present disclosure; FIG. 26B is an elevation view of the separation assembly of FIG. 26A in the packaged configuration according to at least one exemplary embodiment of this disclosure; FIG. 26C is a schematic view of a separation assembly including the separation assembly of FIG. 26A according to at least one embodiment of this disclosure; FIG. 26D is a schematic view of an apheresis system including a component collection assembly correctly installed in accordance with at least one exemplary embodiment of the present disclosure; FIG. 26E is a partial perspective view of a valve housing of the apheresis system of FIG. 26D according to at least one embodiment of this disclosure; FIG. 26F is a schematic view of an apheresis system including a component collection assembly incorrectly installed according to at least one exemplary embodiment of this disclosure; Petition 870250078665, dated 03 / 09 / 2025, p. 51 / 393 36 / 274 FIG. 26G is a schematic view of an AC bag of the separation assembly of FIG. 26C according to at least one exemplary embodiment of this disclosure; FIG. 26H is a schematic view of a saline bag of the separation assembly of FIG. 26C according to at least one exemplary embodiment of this disclosure; FIG. 26I is a perspective view of a vessel in a cradle of the apheresis system of FIG. 26D according to at least one embodiment of this disclosure; and FIG. 26J is a side elevation view of the vessel and cradle of FIG. 26I according to at least one embodiment of this disclosure.

[0041] The corresponding reference numbers indicate the corresponding parts in the various views of the drawings. DETAILED DESCRIPTION

[0042] Examples of embodiments will now be described in more detail with reference to the attached drawings.

[0043] Examples of embodiments are provided so that this disclosure is complete and fully conveys the scope to those skilled in the art. Several specific details are presented, such as examples of specific components, devices, and methods, to provide a complete understanding of the embodiments of the present disclosure. It will be evident to those skilled in the art that specific details need not be employed, that examples of embodiments can be embodied in many different forms, and that none of them should be interpreted as limiting the scope of the disclosure. In some examples of embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0044] The terminology used in this document is intended to describe only particular example modalities and is not intended to be limiting. As used in this document, the Petition 870250078665, dated 03 / 09 / 2025, page 52 / 393 37 / 274 Singular forms of “a,” “an,” “the,” and “the” may also be intended to include plural forms unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “possessing” are inclusive and therefore specify the presence of declared features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described in this document should not be interpreted as necessarily requiring their performance in the specific order discussed or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be employed.

[0045] When an element or layer is referred to as being on, engaged with, connected to, or coupled to another element or layer, it may be directly on, engaged with, connected to, or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being directly on, directly engaged with, directly connected to, or directly coupled to another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted similarly (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used in this document, the term “and / or” includes any and all combinations of one or more of the listed associated items.

[0046] Although the terms first, second, third, etc. may be used in this document to describe various elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections must not be used in this document. Petition 870250078665, dated 03 / 09 / 2025, page 53 / 393 38 / 274 may be limited by these terms. These terms may only be used to distinguish one element, component, region, layer, or section from another region, layer, or section. Terms such as “first,” “second,” and other numerical terms, when used in this document, do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer, or section discussed below could be referred to as a second element, component, region, layer, or section without departing from the teachings of the example modalities.

[0047] Spatially relative terms, such as inside, outside, below, under, above, top, and the like, may be used in this document to facilitate the description of the relationship of one element or feature to another element(s) or feature(s), as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation, in addition to the orientation represented in the figures. For example, if the device in the figures is flipped, the elements described as below or under other elements or features would then be oriented above the other elements or features. Thus, the example term below may encompass both an above and a below orientation. The device may be oriented in another way (rotated 90 degrees or in other orientations) and the spatially relative descriptors used in this document may be interpreted accordingly.

[0048] Several components are referred to in this document as “operationally associated.” As used in this document, “operationally associated” refers to components that are operably linked together and encompasses modes in which components are directly linked as well as modes in which additional components are placed between them. Petition 870250078665, dated 03 / 09 / 2025, p. 54 / 393 39 / 274 Linked Components. Operationally associated components may be fluidly associated. Fluidly associated refers to components that are linked together in such a way that fluid can be transported between them. Fluidly associated encompasses embodiments in which additional components are arranged between the two fluidly associated components, as well as components that are directly connected. Fluidly associated components may include components that do not come into contact with the fluid but do come into contact with other components to manipulate the system (e.g., a peristaltic pump that pumps fluids through flexible tubing by compressing the outside of the tubing).

[0049] The term donor, as used in this document, may mean any person who provides a fluid (e.g., whole blood) to the apheresis system. A donor may also be a patient who provides a fluid to the apheresis system temporarily while the fluid is processed, treated, manipulated, etc., before being given back to the patient.

[0050] The term automatic and its variations, as used in this document, refers to any process or operation performed without material human intervention when the process or operation is performed. However, a process or operation may be automatic even if its performance utilizes material or immaterial human input, if the input is received before the process or operation is performed. Human input is considered material if it influences how the process or operation will be performed. Human input that enables the performance of the process or operation is not considered material.

[0051] The term computer-readable medium, as used in this document, refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. This medium can take many forms, including, but not limited to, non-volatile media, Petition 870250078665, dated 03 / 09 / 2025, page 55 / 393 40 / 274 volatile media and transmission media. Non-volatile media include, for example, NVRAM or magnetic or optical disks. Volatile media include dynamic memory, such as main memory. Common forms of computer-readable media include, for example, a floppy disk, a floppy disk, a hard disk, magnetic tape or any other magnetic media, magneto-optical media, a CD-ROM, any other optical media, punched cards, paper tape, any other physical media with hole patterns, a RAM, a PROM and an EPROM, a FLASH-EPROM, a solid-state medium such as a memory card, any other memory chip or cartridge, a carrier wave as described below, or any other media from which a computer can read. A digital file attachment to an email or other self-contained information file or set of files is considered a distribution medium equivalent to a tangible storage medium.When the computer-readable medium is configured as a database, it should be understood that the database can be any type of database, such as relational, hierarchical, object-oriented, and / or similar. Consequently, the disclosure is considered to include a tangible storage medium or distribution medium and equivalents recognized by the prior art and successor media, in which the software implementations of the present disclosure are stored.

[0052] The term module, as used in this document, refers to any hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software, known or subsequently developed, that is capable of performing the functionality associated with that element.

[0053] The terms determine, calculate and compute, and variations thereof, as used in this document, are used interchangeably and include any type of methodology, process, mathematical operation or technique.

[0054] The modalities of the present disclosure will be described Petition 870250078665, dated 03 / 09 / 2025, page 56 / 393 41 / 274 in more detail with reference to the accompanying drawings and in connection with apheresis methods and systems. The embodiments below can be described with respect to the separation of blood components from whole blood. However, the example procedures are provided for illustrative purposes only. Note that the embodiments are not limited to the description below. The embodiments are intended for use in products, processes, devices and systems for the separation of any compound liquid. Consequently, the present disclosure is not limited to the separation of blood components from whole blood.

[0055] With reference to FIG. 1, a perspective view of an operating environment 100 of an apheresis system 200 is shown according to at least one exemplary embodiment of the present disclosure. The operating environment 100 may include an apheresis system 200, a donor 102, and one or more connections (e.g., donor feed tubing 104, cassette inlet tubing 108A, anticoagulant tubing 110, etc.) that go from the donor 102 to the apheresis system 200 and / or vice versa. As shown in FIG. 1, the donor feed tubing 104 may be fluidically connected to at least one blood vessel, e.g., a vein, of the donor 102 by means of venipuncture. For example, a cannula connected to one end of the donor feeding tubing 104 can be inserted through the donor skin 102 and into a target site, or vein.This connection can provide an intravenous pathway for blood to flow from donor 102 to the apheresis system 200 and / or for blood components to flow back to donor 102. In at least one embodiment, the fluid pathways and connections can form an extracorporeal tubing circuit of the apheresis system 200.

[0056] Blood supplied by donor 102 can flow along donor feed tubing 104 through a tubing connector 106 and along cassette inlet tubing. Petition 870250078665, dated 03 / 09 / 2025, page 57 / 393 42 / 274 108A for a soft cassette assembly 300. The soft cassette assembly 300 may include one or more fluid control paths and valves to selectively control blood flow to and / or from the donor 102. The apheresis system 200 may include an anticoagulant supply contained in an anticoagulant bag (AC) 114. The anticoagulant may be pumped at least through the anticoagulant tubing 110 and tubing connector 106, preventing blood clotting in the apheresis system 200.

[0057] Anticoagulants may include one or more of the following: citrate and / or unfractionated heparin. The AC 114 bag and other bags or vials described in this document may be made of, for example, one or more of the following, but not limited to: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomer, polymers, copolymers and / or combinations thereof. The volume of AC in the AC 114 bag may vary based on several factors, including donor mass 102, donor blood volume flow rate, etc. In one example, the volume in the AC 114 bag may be 250 to 500 mL, although the volume in the AC 114 bag may be greater or less than this volume.

[0058] In at least one embodiment, the apheresis system 200 may include a plasma collection bottle 122, or container, a saline fluid contained in a saline bag 118, and one or more lines or tubing, such as saline tubing 116 and plasma tubing 120 (e.g., fluid transport tubing, etc.) connecting the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200. The amount of saline solution supplied in the saline bag 118 may be from 500 to 800 mL, although the volume in the saline bag 118 may be Petition 870250078665, dated 03 / 09 / 2025, page 58 / 393 43 / 274 greater or less than this volume. An example of a donation of a blood component (e.g., plasma) might be 880 mL. Thus, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one embodiment, the plasma collection bottle 122 may include a connection point disposed of, adjacent to, or in physical proximity to, a substantially lower portion of the plasma collection bottle 122 (e.g., when the plasma collection bottle 122 is installed in a plasma collection cradle 232C, as shown in FIG. 2A). The connection point may include one or more connectors configured to interconnect with plasma tubing 120 to receive and / or transport plasma.The arrangement of the connection point at the bottom of the plasma collection bottle 122 can allow the plasma contained in the plasma collection bottle 122 to exit the plasma tubing 120 back through the lines, as described in this document, without trapping air bubbles, etc. In at least one embodiment, the plasma collection bottle 122 can be configured as a flexible bag, rigid container, and / or other container, and therefore the plasma collection bottle 122 is not limited to bottles or bottle-like containers.

[0059] FIG. 2A shows a perspective view of the apheresis system 200 described in FIG. 1. The apheresis system 200 can provide a continuous whole blood separation process. In at least one embodiment, whole blood can be withdrawn from a donor 102 and supplied substantially continuously to a blood component separation device of the apheresis system 200, where the blood can be separated into various components and at least one of these blood components can be collected from the apheresis system 200. In at least one embodiment, one or more separated blood components can be collected for subsequent use or returned to the donor 102. Blood can be withdrawn from the donor 102 and Petition 870250078665, dated 03 / 09 / 2025, page 59 / 393 44 / 274 directed to a centrifuge of the apheresis system 200 through an opening 220 in an access panel 224 of the apheresis system 200. In at least one embodiment, the tubing, donor feed tubing 104, cassette inlet tubing 108A, inlet tubing 108B (also referred to herein as circuit inlet tubing 108B), outlet tubing 112 (also referred to in this document as circuit outlet tubing 112), saline tubing 116 and plasma tubing 120, used in the extracorporeal tubing circuit may together define a closed, sterile, and disposable system, or blood component collection assembly, which may be described in more detail below.

[0060] Examples of apheresis, plasmapheresis, and other separation systems that can be used with embodiments of the present disclosure (for example, as 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, all manufactured by Terumo BCT, of Lakewood, Colorado.

[0061] The operation of the various pumps, valves, and blood component separation devices, or centrifuges, may be controlled by one or more processors included in the apheresis system 200 and may advantageously comprise a plurality of embedded computer processors that are part of a computer system. The computer system may also include components that allow the user to interact with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.); communication / network devices (e.g., wired, such as modems / network cards, or wireless, such as Wi-Fi); input devices, such as keyboard(s), touch screen(s), camera(s), and / or microphone(s); and output device(s), such as Petition 870250078665, dated 03 / 09 / 2025, page 60 / 393 45 / 274 display(s) and audio system(s), etc. To assist the operator of the apheresis system 200 with various aspects of its operation, in at least one example embodiment, the blood component separation device, or centrifuge, may include a graphical user interface with a display that includes an interactive touch screen.

[0062] The apheresis system 200 may include a housing 204 and / or structural frame, a cover 210, an access panel 224 disposed on the front 202 and / or rear 206 of the apheresis system 200 and one or more supports 232A.-232C including hooks, supports, cradles, arms, protrusions, plates and / or other support features for retaining, packaging and / or otherwise supporting a container or AC bag 114, saline solution bag 118 or plasma collection bottle 122. In at least one embodiment, the features of the apheresis system 200 may be described with reference to a coordinate system 103 and / or one or more axes thereof. Housing 204 may include a machine frame (e.g., made of welded, bolted and / or connected structural elements, extruded material, beams, etc.) to which one or more panels, such as the cover 210, doors, sub-assemblies and / or components are attached.In at least one embodiment, at least one panel of the apheresis system 200 may include a mounting surface for the soft cassette assembly 300, one or more pumps such as an extraction pump 208, a return pump 212 or an anticoagulant (AC) pump 216, and / or a fluid valve control system 228 (e.g., plasma and saline valve control, etc.).

[0063] The access panel 224 may include one or more handles, latches and a rotating or articulated shaft 226 (e.g., door hinge, piano hinge, continuous hinge, cleanroom hinge, etc.). In any case, the access panel 224 may be selectively opened to provide Petition 870250078665, dated 03 / 09 / 2025, page 61 / 393 46 / 274 access to the interior of the apheresis system 200 and, more specifically, to a blood separation assembly, or centrifuge. In at least one embodiment, the access panel 224 may provide access to load and / or unload the centrifuge with one or more components in the blood component collection assembly. The details of the centrifuge are described in more detail at least in relation to FIGS. 4A-4L below.

[0064] The interior of the apheresis system 200 can be separated into at least one centrifuge portion and one control portion. For example, the centrifuge portion may include a cavity configured to house the centrifuge, the rotation motor, and the associated hardware. This area may be physically separated from the control portion by means of one or more cavity walls. In at least one embodiment, access to the control portion (e.g., configured to house or otherwise contain the motor controller, CPU or processor(s), electronic components, wiring, etc.) may be provided by means of a securely fixed housing panel 204 and / or a separate access panel 224.

[0065] In at least one embodiment, the apheresis system 200 may include a series of pumps, such as the extraction pump 208, the return pump 212, or the AC pump 216, configured to control the flow of fluid (e.g., blood and / or blood components, anticoagulant, saline solution, etc.) through the apheresis system 200. For example, the apheresis system 200 may include the extraction pump 208 that controls blood flow to and / or from donor 102 to the centrifuge of the apheresis system 200. The extraction pump 208 may engage with a portion of the inlet tubing 108B disposed between the flexible cassette assembly 300 and the centrifuge of the apheresis system 200. In at least one embodiment, the apheresis system 200 may include the return pump. 212 configured to control a flow of blood components Petition 870250078665, dated 03 / 09 / 2025, page 62 / 393 47 / 274 separate (e.g., plasma, etc.) from the centrifuge to a plasma collection bottle 122 and / or vice versa. Additionally or alternatively, the return pump 212 can control a flow of saline solution (e.g., supplied by the saline bag 118) throughout the blood component collection assembly and / or apheresis system 200. The AC pump 216 can engage with a portion of the anticoagulant tubing 110 to selectively control the flow of anticoagulant throughout the blood component collection assembly of the apheresis system 200. As shown in FIG. 2A, the extraction pump 208, the return pump 212, and the AC pump 216 can be arranged at least partially in an upper portion of the cover 210 of the apheresis system 200.

[0066] FIGS. 2B and 2C show various perspective views of the extraction pump 208, the return pump 212, or the AC pump 216 of the apheresis system 200, according to at least one exemplary embodiment of the present disclosure. Although the extraction pump 208 is shown and described in conjunction 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 AC pump 216, may be different and operate differently in some respects; however, in many cases, the return pump 212 and / or the AC pump 216 may be or include a substantially similar, if not identical, construction to the extraction pump 208 described.

[0067] The extraction pump 208 may include a pump cover 236 or a housing configured to at least partially enclose the moving elements of the extraction pump 208. In at least one embodiment, the pump cover 236 may include a hinged pipe protection door subassembly or a pipe protection 240 that is configured to open and close around a hinge axis of the pipe protection 242. In at least one embodiment of Petition 870250078665, dated 03 / 09 / 2025, page 63 / 393 In embodiment 48 / 274, the pipe protection 240 can be fixed to the pump cover 236 by means of one or more fasteners arranged along the articulation axis of the pipe protection 242. As shown in FIGS. 2B and 2C, blood supplied by donor 102 can be transported, or collected, by extraction pump 208 to a centrifuge in a first extraction direction or centrifuge 250A. Additionally or alternatively, blood or other fluid can be transported or extracted by extraction pump 208 towards donor 102 in a donor direction 250B, opposite to the direction of centrifuge 250A.

[0068] In at least one embodiment, the extraction pump 208 and / or the return pump 212 and the AC pump 216 may be a pipe pump, peristaltic pump, diaphragm pump and / or other pump configured to handle fluid flow (e.g., blood, blood components, anticoagulant, saline solution, etc.) in at least a portion of the piping. For example, the extraction pump 208, the return pump 212 or the AC pump 216 may include a motor operatively interconnected with a rotary pipe contact assembly. In operation, the piping (e.g., the inlet piping 108B, the outlet piping 112, the anticoagulant piping 110, etc.) may be inserted into a main pipe guide 244, a pipe pressure block 248 and an end pipe guide 252 adjacent to a rotary pipe contact head.In at least one embodiment, the pressure block of the pipe 248 may be moved in a direction away from the contact head of the rotating pipe of the extraction pump 208, the return pump 212, or the AC pump 216, providing a load clearance area, or vice versa. The contact head of the rotating pipe may comprise a series of rotating pressure rollers 268 configured to rotate about the respective rotation axes of pressure rollers 264. Each of the rotating pressure rollers 268 may be... Petition 870250078665, dated 03 / 09 / 2025, page 64 / 393 49 / 274 arranged between a first rotary pump plate 272A and a second rotary pump plate 272B, wherein the first rotary pump plate 272A and the second rotary pump plate 272B are configured to rotate about a pump rotation axis 260. In at least one embodiment, rotary pressure rollers 268 may be arranged on the periphery of the first rotary pump plate 272A and the second rotary pump plate 272B.

[0069] One or more of the 208 extraction pumps, 212 return pumps, or 216 AC pumps may include, or operate similarly to, the Pulsafeeder® peristaltic pump model UX-74130, Pulsafeeder® MEC-O-MATIC pump series, all manufactured by Pulsafeeder Inc., Punta Gorda, Florida, without limitation. Other examples of the 208 extraction pump, 212 return pump, or 216 AC pump may include, but are not limited to, the INTEGRA DOSE IT laboratory peristaltic pump manufactured by INTEGRA Biosciences AG, Switzerland, and the WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM peristaltic pump series, all manufactured by WELCO Co., Ltd., Tokyo, Japan.

[0070] Once the piping is loaded into the main piping guide 244, the piping pressure block 248, and / or the end piping guide 252, at least some of the rotating pressure rollers 268 can be forced to engage, contact, or otherwise compress the piping disposed between the rotating piping contact head and the piping pressure block 248. As the first rotary pump plate 272A and the second rotary pump plate 272B rotate about the pump rotation axis 260, the rotating pressure rollers 268 can compress a portion of the piping between the extraction pump 208, the return pump 212, or the AC pump 216 and the piping pressure block 248, positively displacing the fluid within the portion of piping in a specific direction, such as the centrifugal direction 250A or the Petition 870250078665, dated 03 / 09 / 2025, page 65 / 393 50 / 274 direction of donor 250B, as the rotating pressure rollers 268 move. For example, as the first rotating pump plate 272A and the second rotating pump plate 272B rotate counterclockwise around the axis of rotation of the pump 260, the rotation of the rotating pressure rollers 268 compressing the piping between the rotating pressure rollers 268 and the piping pressure block 248 can displace, or pump, fluid in the direction of the centrifuge 250A. As another example, as the first rotary pump plate 272A and the second rotary pump plate 272B rotate clockwise around the pump rotation axis 260, the rotation of the rotary pressure rollers 268 compressing the piping between the rotary pressure rollers 268 and the piping pressure block 248 can displace, or pump, fluid in the direction of the donor 250B.When not actively pumping, pump 208 can be maintained in a state where at least one of the rotating pressure rollers 268 continues to obstruct the inlet pipe 108B (normally closed or NC) or in a state where neither of the rotating pressure rollers 268 obstructs the inlet pipe 108B (normally open or NO). Thus, extraction pump 208, depending on its stationary state, can also function as a valve to prevent or allow fluid movement. This capability may also be available with return pump 212 and / or AC pump 216.

[0071] The pipe guard 240 and the pump cover 236 can serve to protect an operator (e.g., phlebotomist, apheresis technician, etc.) and / or the donor 102 from accidental contact with one or more moving parts of the extraction pump 208, the return pump 212, or the AC pump 216. In at least one embodiment, the pipe guard 240 can be maintained in a closed position by means of one or more protective closing features 254 arranged in or in operational relation to the pipe guard 240, the pipe guide. Petition 870250078665, dated 03 / 09 / 2025, page 66 / 393 51 / 274 main 244, to the pipe pressure block 248 and / or to the end pipe guide 252. In some cases, these protective closing features 254 may be magnets contained in the pipe protection 240, in the main pipe guide 244, in the pipe pressure block 248 and / or in the end pipe guide 252. In at least one embodiment, the extraction pump 208, the return pump 212 or the AC pump 216 may be stopped or prevented from moving / operating when the pipe protection 240 is open. In at least one embodiment, a door closing sensor may be included in the protective closing features 254, in the main pipe guide 244, in the end pipe guide 252 and / or in the pipe pressure block 248.

[0072] One or more fluid control valves may be used to control the routing or direction of the flow of fluid carried through the tubing of the apheresis system 200. In at least one embodiment, the apheresis system 200 may include a plasma and saline valve control system, such as the fluid valve control system 228 disposed adjacent to the saline bag 118 and / or the plasma collection bottle 122. The fluid valve control system 228 is shown in the detailed perspective view of FIG. 2D.

[0073] As shown in FIG. 2D, the outlet pipe 112 can pass through the return pump 212 and interconnect with a Y-connector 280 for saline and plasma piping. The Y-connector for saline and plasma piping 280 can allow connection of the outlet pipe 112 to a saline piping line 116 and a plasma piping line 120. The fluid valve control system 228 may include an air detection sensor 284 disposed at one end of the saline and plasma valve housing 276 and encircling a portion of the outlet pipe 112. The sensor of Petition 870250078665, dated 03 / 09 / 2025, page 67 / 393 52 / 274 air detection 284 can be any light, ultrasonic, or other type of sensor that can detect the presence of fluid or air in the outlet pipe 112 and provide this signal to an apheresis system controller 200. Types of air detection sensors 284 may include, for example, the SONOCHECK ABD05, manufactured by SONOTEC US Inc., or another similar sensor.

[0074] The saline and plasma solution valve housing 276 may include a number of receiving features (e.g., grooves, channels, receptacles, etc.) that receive a portion of the outlet piping 112, the saline piping 116, the plasma piping 120, and / or the saline and plasma piping Y-connector 280. Upon detecting air in the outlet piping 112, the fluid valve control system 228 may selectively actuate one or more fluid control valves, such as a plasma flow control valve 286 and a saline solution flow control valve 288. In at least one embodiment, air detection by means of the air detection sensor 284 may be used to signal an operating step and / or trigger a step in a control method as described in this document.

[0075] The plasma flow control valve 286 and / or the saline solution flow control valve 288 may be a solenoid valve, linear actuator, clamp valve, clamp valve, pipe valve and / or other actuatable valve configured to selectively alter (e.g., occlude) a fluid passage associated with a specific portion of the outlet pipe 112, the saline pipe 116 or the plasma pipe 120. As shown in FIG. 2D, the plasma flow control valve 286 may be configured to compress a portion of the plasma pipe 120, at least partially contained within a receiving feature of the plasma and saline solution valve housing 276. The saline solution flow control valve 288 may be configured to compress a portion of the Petition 870250078665, dated 03 / 09 / 2025, page 68 / 393 53 / 274 saline solution tubing 116, at least partially contained within a receiving feature of the saline and plasma valve housing 276. In any case, the plasma flow control valve 286 and the saline flow control valve 288 may include an actuatable extendable finger that moves from a retracted, or partially retracted, position to an extended, or partially extended, position to compress the portion of tubing contained within the saline and plasma valve housing 276.Although the plasma flow control valve 286 and the saline solution flow control valve 288 can completely compress the piping (i.e., completely restricting fluid flow through it), it should be understood that the plasma flow control valve 286 and the saline solution flow control valve 288 can be partially actuated to a position that partially restricts fluid flow through a portion of the piping.

[0076] As should be understood, extraction pump 208, return pump 212 and AC pump 216 include additional components, such as those described by Atty. Document No. 18955000029-US, entitled “FLUID CONTROL AND BYPASS FEATURES FOR AN APHERESIS SYSTEM”, filed on March 2, 2023 and designated as Application No. 18 / 116,527, the full contents of which are incorporated herein by reference. FIRST EXAMPLE OF SOFT CASSETTES WITH INTEGRATED FEATURES

[0077] FIG. 3A is a partial perspective view of a soft cassette assembly according to at least one embodiment.

[0078] In at least one embodiment, as shown in FIG. 3A, a detailed perspective view of a disposable soft cassette assembly 300 is shown according to the embodiments of the present disclosure. The soft cassette assembly 300 may include a base plate 302 and a port of Petition 870250078665, dated 03 / 09 / 2025, page 69 / 393 54 / 274 access to cassette 304 which is fixed to the base plate 302 by means of at least one hinge 306 and / or cassette access door latch 308. In at least one embodiment, the cassette access door 304 can be unlocked by actuating a cassette access door latch 308 and rotating the cassette access door 304 around a cassette access door hinge axis 310.

[0079] In at least one embodiment, the soft cassette assembly 300 may be configured with one or more soft cassette receiving features 312 to contain and / or locate at least partially a soft cassette 314 therein. The soft cassette 314 may be part of the blood component collection assembly described in this document. For example, the soft cassette 314 may be disposed between the cassette inlet tubing 108A and the circuit inlet tubing 108B of the extracorporeal tubing circuit (shown in FIG. 5A). In at least one embodiment, the flexible cassette 314 may provide one or more features to control the flow of blood and / or blood components from a donor 102 (shown in FIG. 1A) to the apheresis system 200 (shown in FIG. 1A) and / or vice versa.

[0080] In at least one embodiment, the soft cassette assembly 300 includes an air sensing sensor 316, a fluid sensor 318, and one or more fluid control valves 320A, 320B, 320C configured to control a routing or direction of fluid flow through the soft cassette 314. In at least one embodiment, these components may be independently incorporated into the cassette access door 304, the base plate 302, and / or a portion of the housing 204 of the apheresis system 200 (shown in FIG. 1A). Similar to the protective closure feature 254 described in conjunction with FIGS. 2B-2C, the soft cassette assembly 300 may include one or more door closure features 328. The features of Petition 870250078665, dated 03 / 09 / 2025, page 70 / 393 55 / 274 Door closure 328 may include, but is not limited to, magnetic latches, protrusions, tabs and grooves and / or other connections. In at least one embodiment, the door closure features 328 may include pressure contact surfaces configured to retain or at least partially position a soft cassette 314 within the soft cassette assembly 300.

[0081] In at least one embodiment, valves 320A, 320B, 320C may include, but are not limited to, solenoid valves, linear actuators, clamp valves, clamp valves, pipe valves and / or other actuatable valves configured to selectively alter, for example, occlude, a fluid passage (e.g., cross-sectional area, etc.) associated with a specific portion of the soft cassette 314.

[0082] In at least one embodiment, the soft cassette assembly 300 may include a first fluid control valve 320A configured to compress a portion of the soft cassette 314 adjacent to an inlet pipe of the cassette 108A. The second fluid control valve 320B may be configured to compress a portion of the soft cassette 314 adjacent to the circuit inlet pipe 108B. An extraction fluid control valve 320C may be configured to compress a portion of the flexible cassette 314 along a bypass pipe extending from a point adjacent to the inlet pipe of the cassette 108A to a point adjacent to the circuit inlet pipe 108B.In at least one embodiment, each of the 320A, 320B, 320C valves may include an actuated extendable finger that moves from a retracted, or partially retracted, position to an extended, or partially extended, position to compress the portion of the soft cassette 314 contained within the soft cassette assembly 300. Although the 320A, 320B, 320C valves may fully compress the paths of... Petition 870250078665, dated 03 / 09 / 2025, page 71 / 393 56 / 274 flow in the soft cassette 314 (for example, completely restricting the flow of fluid through them), it should be understood that valves 320A, 320B, 320C can be partially actuated to a position that partially restricts the flow of fluid through a portion of the soft cassette 314.

[0083] In at least one embodiment, the sensors 316, 318 may be one or more of an ultrasonic detector, pressure sensor, magnetic position sensor, and / or the like. In some cases, the fluid sensor 318 may be configured to determine whether fluid is present in the soft cassette 314 based on the position of a magnet relative to a portion of the soft cassette 314. For example, when the portion of the soft cassette 314 is filled with a fluid, the magnet may be disposed in a first position from a surface of the soft cassette 314. Conversely, when the portion of the soft cassette 314 is filled with air, the force of the magnet may compress the portion of the soft cassette 314 to a second position closer to the surface of the soft cassette 314 than the first position.In at least one embodiment, the detection of air or fluid by means of the air detection sensor 316 and the fluid sensor 318, respectively, can be used to signal an operating step and / or trigger a step in a control method as described in this document.

[0084] FIG. 3B is a perspective view of a soft cassette from the soft cassette assembly of FIG. 3A according to at least one embodiment. FIG. 3C is a sectional view of the soft cassette of FIG. 3B taken along line 3C-3C of FIG. 3A according to at least one embodiment. FIG. 3D is a sectional view of the soft cassette of FIG. 3A taken along line 3D-3D of FIG. 3A according to at least one embodiment.

[0085] In at least one example of modality, the cassette Petition 870250078665, dated 03 / 09 / 2025, page 72 / 393 The flexible cassette 314 (57 / 274) can be part of a blood component collection set. For example, the soft cassette 314 can be a disposable component used in the blood separation methods described in this document. In at least one embodiment, the soft cassette 314 can be made of a substantially flexible and / or compliant material. The compliant material can be chemically inert and / or capable of withstanding sterilization and cleaning operations, temperatures, and / or treatments. The soft cassette 314 can be formed from a thermoplastic material. In at least one embodiment, the soft cassette 314 includes polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastic elastomer, copolymers thereof, and / or combinations thereof.In at least one embodiment, the 314 soft cassette is molded, rotomolded, cast, injection molded, or otherwise formed from one or more of the materials described above.

[0086] In at least one embodiment, the soft cassette 314 may include and / or define a first cassette port 340A (shown in FIGS. 3B-3C), a second cassette port 340B (shown in FIGS. 3B-3C), and a direct flow lumen 350 (shown in FIG. 3C) passing between the first and second cassette ports 340A, 340B. In at least one embodiment, the first and / or second cassette ports 340A, 340B may be configured to receive and / or fluidically couple with one or more tubes of the blood component collection assembly. In at least one embodiment, the first cassette port 340A may be coupled to cassette inlet tubing 108A and the second cassette port 340B may be coupled to circuit inlet tubing 108B. These couplings can be airtight and / or fluid-tight. In at least one embodiment, the first and / or second cassette ports 340A, 340B can be or include an opening arranged Petition 870250078665, dated 03 / 09 / 2025, page 73 / 393 58 / 274 inside the soft cassette 314 which is configured to stretch elastically around one end of the tubing (e.g., 108A cassette inlet tubing, 108B circuit inlet tubing, etc.).

[0087] In at least one embodiment, blood supplied by donor 102 (shown in FIG. 1A) may be directed along one or more fluid paths arranged within the soft cassette 314. In one embodiment, blood may be directed along the direct flow lumen 350 from the first cassette port 340A to the second cassette port 340B. In some embodiments, this flow path may direct blood through a first chamber or drip chamber 354 of the soft cassette 314. In some embodiments, blood and / or other fluids returned to donor 102 may be directed along the direct flow lumen 350 from the second cassette port 340B to the first cassette port 340A.

[0088] In at least one embodiment, the soft cassette 314 includes a fluid flow bypass path provided by a first bypass branch 358 (shown in FIGS. 3B, 3D) having a bypass flow lumen 360 (shown in FIG. 3D) that is fluidly connected to a portion of the direct flow lumen 350 adjacent to the first cassette port 340A or as part of the first cassette port 340A. In some embodiments, the bypass flow lumen 360 may run from a point on the direct flow lumen 350 adjacent to the first cassette port 340A, along the first bypass branch 358, through a second fluid pressure chamber or ring 362 (shown in FIGS. 3B, 3D) to a second bypass branch 364 (shown in FIGS. 3B, 3D) and then reconnect to the direct flow lumen 350 at a point adjacent to the second cassette port 340B or as part of the second cassette port 340B.As the name suggests, the 364 bypass flow lumen provides a flow path within the 314 soft cassette that bypasses the chamber. Petition 870250078665, dated 03 / 09 / 2025, page 74 / 393 59 / 274 drip 354.

[0089] In at least one embodiment, flow path control, or fluid direction, within the soft cassette 314 may include actuating fluid control valves 320A, 320B, 320C (shown in FIG. 3A) of the soft cassette assembly 300 to interact with various compliant regions 370A, 370B, 370C (shown in FIG. 3B) by blocking and / or opening portions of the forward flow lumen 350 and / or the bypass flow lumen 360. The first compliant region 370A provides a clamping valve area at a point along the forward flow lumen 350 between the first cassette port 340A and the drip chamber 354 near a first cassette end 372 of the soft cassette 314. When the first fluid control valve 320A is When activated, valve 320A can compress the closed direct flow lumen 350 in this first compliant region 370A, restricting or completely preventing fluid flow at this point in the soft cassette 314.The second compliant region 370B provides a clamping valve area at a point along the direct flow lumen 370 between the second cassette port 340B and the drip chamber 354 near a second cassette end 374 (e.g., opposite the first cassette end 372). When the second fluid control valve 320B is actuated, the valve 320B can compress the closed direct flow lumen 370 in this second compliant region 370B, restricting or completely preventing fluid flow at this point in the soft cassette 314. As can be observed, the third compliant region 370C disposed along the first bypass branch 358 adjacent to the fluid pressure ring 362 can provide a clamping valve area at a point along the bypass flow lumen 360.When the extraction fluid control valve 320C is actuated, the valve 320C can compress the closed bypass flow lumen 360 in this third compliant region 370C, restricting or... Petition 870250078665, dated 03 / 09 / 2025, page 75 / 393 60 / 274 completely preventing fluid flow through the 360° bypass flow lumen.

[0090] In at least one embodiment, as shown in the sectional view of FIG. 3C, taken through a plane passing through the direct flow lumen 350 and the drip chamber 354, the direct flow lumen 350 runs from the first port of the cassette 340A through an inner chamber volume 376 of the drip chamber 354 to the second port of the cassette 340B. The direct flow lumen 350 may be formed as a fluid passage running within a first tubing section 378, the inner chamber volume 376, and a second tubing section 379 of the soft cassette 314.

[0091] In at least one embodiment, the bypass path of the soft cassette 314 may include the fluid pressure ring 362 through which fluid may flow from the first bypass branch 358 to the second bypass branch 364, and / or vice versa. In at least one embodiment, a pressure diaphragm 380 (shown in FIG. 3D) may be formed in the soft cassette material 314 an area within or adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and the pressure diaphragm 380 are illustrated in the elevation section view of FIG. 3D taken through a plane passing through the fluid pressure ring 362 and a portion of the first and second bypass branches 358, 364.

[0092] In at least one embodiment, the pressure diaphragm 380 can provide a contact or measurement surface for the fluid sensor 318 to detect whether the fluid pressure ring 362 and / or the bypass flow lumen 360 include a quantity of fluid, air, and / or combinations thereof. As provided above, as fluid fills a portion of the fluid pressure ring 362, the fluid can provide greater resistance to movement than when the fluid pressure ring 362 is filled with air. This difference in resistance Petition 870250078665, dated 03 / 09 / 2025, page 76 / 393 61 / 274 can be measured by means of the fluid sensor 316 to determine, among other things, a quantity and / or type of fluid (e.g., air, blood, etc.) in the bypass flow lumen 360 and / or in the fluid pressure ring 362. EXAMPLE OF CENTRIFUGE ASSEMBLY

[0093] FIG. 4A is a perspective view of an example of centrifuge assembly 400 for use in apheresis system 200 according to at least one embodiment of the present disclosure. The centrifuge assembly 400 may be disposed of in an internal space of the apheresis system 200. The internal space may be at least partially enclosed with one or more elements of the housing 204 and / or centrifuge chamber. Access to the internal space and the centrifuge assembly 400 may be provided through the access panel 224 disposed of on the front part 202 of the apheresis system 200. For example, in FIG. 4A, the access panel 224 is shown in an open position, open along the hinged axis 226. The hinged axis 226 may correspond to a door hinge, continuous hinge, cleanroom hinge and / or other panel hinges.

[0094] The centrifuge assembly 400 can be operationally mounted within the apheresis system 200 so that the assembly 400 is able to rotate relative to the housing 204 and / or other elements of the apheresis system 200. The centrifuge assembly 400 can be loaded with one or more portions of the blood component collection assembly (e.g., the blood component collection assembly 500 illustrated in FIGS. 5A-5H) by routing tubing (e.g., the inlet tubing 108B and the outlet tubing 112, etc.) into the internal space of the apheresis system 200 (e.g., through the opening 220 shown in FIG. 2A), connecting a portion of the blood component collection circuit 520 to the fixed circuit connection 402 and inserting the blood component collection bladder 536 into a filler 460. The connection of fixed circuit Petition 870250078665, dated 03 / 09 / 2025, p. 77 / 393 62 / 274 402 maintains the inlet tubing 108B and the outlet tubing 112 in a fixed position and can prevent the 108B, 112 tubing from twisting out of the apheresis system 200. In at least one embodiment, the blood component collection circuit 520 can be interconnected to the fixed circuit connection 402 by means of one or more coded features or positive locating features.

[0095] For illustrative purposes, FIGS. 4B-4C show the centrifuge assembly 400 separated from the apheresis system 200. The centrifuge assembly 400 may include a split centrifuge housing 404 comprising a lower housing 404A articulatedly connected to an upper housing 404B. The upper housing 404B may open to provide access for loading a blood component collection bladder (e.g., the blood component collection assembly 500 illustrated in FIGS. 5A-5H) into the centrifuge assembly 400. In at least one embodiment, the upper housing 404B may rotate about the articulation axis of the split housing 406 (e.g., configured as a hinge, pin, fastener, shoulder screw, etc.).

[0096] The different halves (e.g., the lower housing 404A and the upper housing 404B) of the split centrifuge housing 404 can be configured to lock and / or unlock together. Unlocking the upper housing 404B from the lower housing 404A can provide access to the interior of the centrifuge assembly 400. This selective locking can be achieved by rotating the upper housing 404B relative to the lower housing 404A around the axis of rotation of the centrifuge 430. Although the split centrifuge housing 404 is shown in FIGS. 4B-4C in an unlocked state, it should be noted that the upper housing 404B can be rotated (e.g., counterclockwise) around the axis of rotation of the centrifuge 430 to engage one or more tabs. Petition 870250078665, dated 03 / 09 / 2025, p. 78 / 393 63 / 274 locking 428 or upper housing elements 404B with locking grooves 432 arranged in the lower housing 404A (as shown, for example, in FIG. 4C). When in the unlocked position, the upper housing 404B can be opened or rotated around the articulation axis of the split housing 406 to load the centrifuge assembly 400 with a blood component collection circuit 520 and / or a blood component collection bladder 536. When in the locked position, the upper housing 404B is rotationally locked relative to the lower housing 404A, and the two halves of the centrifuge split housing 404 can rotate together, locked in unison, during a centrifuge or blood separation operation.

[0097] The centrifuge assembly 400 may include at least one clockwise rotation stop 408A, one counterclockwise rotation stop 408B, one clockwise rotation indicator for the upper housing 410A and / or one counterclockwise rotation indicator for the upper housing 410B. In at least one embodiment, the rotation stops 408A, 408B may be rotationally fixed relative to the rotation axis of the centrifuge 430 of the lower housing 404A. The rotation flags 410A, 410B can be fixed or formed in the upper housing 404B and configured to contact the respective rotation stops 408A, 408B to prevent excessive rotation of the upper housing 404B relative to the lower housing 404A when locking and / or unlocking the two halves of the split centrifuge housing 404 together.For example, when rotating the upper housing 404B clockwise, or unlocking it, around the centrifuge axis of rotation 430, a portion of the clockwise rotation flag of the upper housing 410A may contact the clockwise rotation stop 408A, preventing further clockwise rotation. Additionally or alternatively, when rotating the... Petition 870250078665, dated 03 / 09 / 2025, page 79 / 393 64 / 274 upper housing 404B in a counterclockwise, or locking, direction around the centrifuge rotation axis 430, a portion of the counterclockwise rotation flag of the upper housing 410B may contact the counterclockwise rotation stop 408B, preventing further rotation in the counterclockwise direction. In at least one embodiment, the split centrifuge housing 404 may include one or more locking elements configured to hold the halves of the split centrifuge housing 404 in a locked state while the locking elements are engaged.

[0098] In at least one embodiment, the split housing 404 of the centrifuge may include 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 around the articulation axis of the split housing 406. The pull ring 412 may provide an opening through which a user may insert a finger and apply a pulling force to a rotationally unlocked upper housing 404B.

[0099] The centrifuge assembly 400 may include a rotor and motor assembly 414 that is controlled and / or powered by means of electrically interconnected wiring 420. The wiring 420 may include a connector that connects to a controller, processor and / or power supply. This wiring 420 may transmit power and / or data signals between the rotor and motor assembly 414 and one or more controllers / processors of the apheresis system 200. The rotor and motor assembly 414 may be configured as an electric motor and / or portions of an electric motor that rotate the complete centrifuge assembly 400 relative to the apheresis system 200 (e.g., relative to a portion of the housing 204 and / or base of the apheresis system 200). In other words, the rotor and motor assembly 414 may include one or more components that make up the centrifuge assembly 400 (for example, Petition 870250078665, dated 03 / 09 / 2025, page 80 / 393 65 / 274 both halves of the split centrifuge housing 404 together) to rotate within the apheresis system 200.

[0100] As described in this document, the centrifuge assembly 400 may include one or more features for guiding, containing, and / or positioning elements of the blood component collection assembly relative to the centrifuge split housing 404. For example, in FIG. 4B, the blood component collection circuit 520 is shown captured in an operating position in a circuit rotational positioning guide 424 comprising a circuit capture arm 416. The circuit rotational positioning guide 424 may include a series of bearings 417 and / or support surfaces, arranged to at least partially support the blood component collection circuit 520 in an operating position. In the operating position, the blood component collection circuit 520 may twist along its length within the support provided by the bearings 417 of the circuit rotational positioning guide 424.For example, the blood component collection circuit 520 can be fixed at one end to the fixed circuit connection 402 of the apheresis system 200, while the other end of the blood component collection circuit 520 can be fixed to a filler 460 (e.g., the internal rotating component of the centrifuge assembly 400). As the centrifuge assembly 400 rotates during a centrifugation operation, the twisting of the blood component collection circuit 520 between the fixed circuit connection 402 and the connection on the filler 460 can cause the filler 460 to rotate relative to the split centrifuge housing 404 of the centrifuge assembly 400. In at least one embodiment, the low inertia of the filler 460, together with the twisting of the blood component collection circuit 520, as the centrifuge assembly 400 rotates It rotates in the 200 apheresis system; you can make the filling rotate 460 times in one. Petition 870250078665, dated 03 / 09 / 2025, p. 81 / 393 66 / 274 angular velocity twice that of the split housing of centrifuge 404 in the same direction of rotation. In this example, when the split housing of centrifuge 404 rotates counterclockwise around the axis of rotation of centrifuge 430 at a first angular velocity, 1ω, the packing 460 can rotate within the split housing of centrifuge 404 counterclockwise at a second angular velocity, 2ω (e.g., substantially twice the first angular velocity, etc.).

[0101] The centrifuge assembly 400 may include one or more balancing features, elements and / or structures arranged around the axis of rotation of the centrifuge 430 of the centrifuge assembly 400. These balancing features may provide an axially balanced centrifuge assembly 400, such that when rotated on the axis of rotation of the centrifuge 430, the centrifuge assembly 400 may transmit substantially no vibration to the apheresis system 200. In at least one embodiment, a centrifuge balance weight 418 may be attached to a portion of the split centrifuge housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). This centrifuge balance weight 418 can be custom adjusted for the centrifuge assembly 400 and, as such, can be selectively connected to and removed from the centrifuge assembly 400.The balance weight adjustment of centrifuge 418 can be calculated and / or derived empirically to produce a fully balanced centrifuge 400 assembly, especially when loaded with one or more elements of the blood component collection assembly.

[0102] FIG. 4C shows a rear perspective view of the centrifuge assembly 400 according to at least one embodiment of the present disclosure. A portion of the packing 460 is visible through an opening in the upper housing. Petition 870250078665, dated 03 / 09 / 2025, p. 82 / 393 6Ί / 2Ί4 404B. The blood component collection circuit 520 is shown in an initial circuit loading position 520A, where a first end is interconnected with the filling 460 and a second end is fixed to the fixed circuit connection 402 (not shown). The blood component collection circuit 520 is shown passing through a circuit access passage 436 in the centrifuge split housing 404. When the blood component collection circuit 520 is loaded in the circuit loading position 520A, a portion of the blood component collection circuit 520 may be partially contained, retained and / or supported by a circuit containment support 426. The circuit containment support 426 may include one or more bearings 41Ί (e.g., roller bearings, ball bearings, needle bearings, etc., and / or sets thereof, etc.).), or support surfaces, arranged to at least partially support the blood component collection circuit 520 as it rotates relative to the centrifuge assembly 400. In at least one embodiment, the blood component collection circuit 520 may rotate about an axis running along the length of the flexible circuit 524 (e.g., in an installed or assembled condition and / or state, etc.) allowing relative rotational movement of the flexible circuit 524 to the circuit rotational position guide 424. For example, the circuit does not twist, but actually rotates, or rolls, relative to the circuit rotational position guide 424 (e.g., support structure) between one or more bearings 41Ί. This rotation or twisting, without trapping or twisting the flexible circuit 524, may be referred to in this document as twisting.The twisting allows the flexible circuit 524 to transmit rotational force to the filling 460 without a substantial reduction in the internal diameter of the flexible circuit 524 lumen. In some cases, there is no reduction in the internal diameter of the flexible circuit 524 lumen. Petition 870250078665, dated 03 / 09 / 2025, page 83 / 393 68 / 274

[0103] As described above, when the upper housing 404B is rotated from the rotationally unlocked position shown in FIGS. 4B-4C, to a rotationally locked position, the locking tab 428 of the upper housing 404B can engage with the locking groove 432 in the lower housing 404A. Additionally or alternatively, when moved to the rotationally locked position, the circuit containment support 426 can rotate, along with the blood component collection circuit 520 and the upper housing 404B, to a position aligned with the circuit rotational position guide 424 along the engaged circuit position 520B.In at least one embodiment, the circuit capture arm 416 can guide the blood component collection circuit 520 to the bearings 417 and / or support surfaces of the circuit rotational position guide 424 as the upper housing 404B and the blood component collection circuit 520 rotate to the engaged circuit position 520B. Further details regarding the loading of the blood component collection circuit 520 are described in conjunction with FIGS. 6A-7B below.

[0104] FIGS. 4D-4F show various schematic sectional views taken through the center of the centrifuge assembly 400 (e.g., bisecting the centrifuge assembly 400 through the centrifuge rotation axis 430, etc.). As described above, the centrifuge assembly 400 may include a lower housing 404A which is articulated to an upper housing 404B by a split housing articulation shaft 406, or hinge. The upper housing 404B may be attached to an upper housing adapter 440 which is rotationally interconnected to the upper housing bushing block 442 attached to the pull ring 412. In at least one embodiment, a bearing 417, bushing or bearing surface may be disposed between the upper housing adapter 440 and the bushing block of the Petition 870250078665, dated 03 / 09 / 2025, p. 84 / 393 69 / 274 upper housing 442, allowing the upper housing 404B to rotate along the axis of rotation of the centrifuge 430 from a locked position to an unlocked position, and vice versa. The pull ring 412 can be rotationally fixed around the axis of rotation of the centrifuge 430 relative to the lower housing 404A. In at least one embodiment, the upper housing adapter 440 and the upper housing 404B can be formed from an integral structure.

[0105] The packing 460 can be fixed to a packing mandrel 434 which is configured to rotate relative to the upper housing 404B around the axis of rotation of the centrifuge 430. In at least one embodiment, the packing mandrel 434 can be formed from a portion of the packing 460. In either case, one or more mandrel support bearings 444 can be arranged between the packing mandrel 434 and the upper housing adapter 440, allowing the packing 460 to rotate within the split housing of the centrifuge 404 and the centrifuge assembly 400 around the axis of rotation of the centrifuge 430. In at least one embodiment, the packing mandrel 434 can be retained in an operating position by means of at least one retaining nut 438. The packing 460 and the packing mandrel 434 They can rotate together relative to the split housing of the 404 centrifuge.

[0106] FIG. 4D shows a schematic sectional view of the centrifuge assembly 400 in the closed state (e.g., before loading the blood component collection circuit 520). By unlocking the upper housing 404B relative to the lower housing 404A, an operator can pull the pull ring 412 to rotate the entire upper housing 404B and the packing 460 around the articulation axis of the split housing 406. In at least one embodiment, the upper housing 404B and the packing 460 can be partially opened by rotating Petition 870250078665, dated 03 / 09 / 2025, p. 85 / 393 70 / 274 the components around the articulation axis of the split housing 406 in an opening direction 446. For example, as illustrated in FIG. 4E, where the centrifuge assembly 400 is shown in a partially open state, the upper housing 404B and the packing 460 are rotated outwards from the axis of rotation of the lower housing 430A. In this position, the packing 460 can rotate around the axis of rotation of the packing 430B. When the lower housing 404A and the upper housing 404B are in a closed state, the axis of rotation of the lower housing 430A and the axis of rotation of the packing 430B align (coincidentally, or substantially coincidentally) to form the axis of rotation of the centrifuge 430.

[0107] Continuing to rotate the upper housing 404B and the filling 460 around the y-axis of the articulation axis of the split housing 406 in the opening direction 446 (e.g., continuing to pull the pull ring 412) can cause the upper housing 404B and the filling 460 to rotate substantially 180 degrees from the closed position shown in FIG. 4D. As shown in FIG. 4F, the centrifuge assembly 400 is in an open or loading state. In this position, the upper housing 404B and the fill 460 can be rotated out of the internal space of the apheresis system 200. For example, at least a portion of the upper housing 404B and / or the fill 460 can be positioned through an open space of the open access panel 224. In this position, a load access area 450 can be provided to the circuit connection area 454 of the fill 460.As can be observed, the orientation of the upper housing 404B in the open position provides easy access to the interior of the upper housing 404B and to the filler 460. Among other things, this arrangement can provide ample space for an operator to connect the blood component collection circuit 520 to the filler 460 in the area. Petition 870250078665, dated 03 / 09 / 2025, page 86 / 393 71 / 274 circuit connection 454.

[0108] With reference to FIG. 4G, a perspective view of a 460 packing for the 400 centrifuge assembly is shown according to at least one embodiment of the present disclosure. In at least one embodiment, the 460 packing can be made of a lightweight material such as plastic, carbon fiber, aluminum, etc. In at least one embodiment, the 460 packing can be three-dimensionally (3D) printed using a 3D printing machine. For example, the 460 packing can be produced using an additive manufacturing technique or system such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or other additive manufacturing machines. Among other things, these additive rapid prototyping manufacturing techniques can allow for more complex geometries of the 460 packing, which may not be possible through the use of conventional machining or manufacturing processes.In at least one embodiment, the material of the 460 filler can be selected based on the desired mass of the 460 filler, the desired physical strength of the manufactured 460 filler, and / or the material suitable for use in manufacturing.

[0109] The filler 460 may include a circuit connection area 454 disposed substantially in the center of the filler 460. The circuit connection area 454 may include one or more encoding, or positive locating, features for a portion of the blood component collection circuit 520 for engagement. As shown in FIG. 4G, the circuit connection area 454 includes a first positive locating feature 478 disposed along a portion of the center axis of the filler 460. The first positive locating feature 478 may be a groove, slot, slit, or other feature for engagement with a coupling feature disposed in the blood component collection circuit 520. In at least one example of Petition 870250078665, dated 03 / 09 / 2025, page 87 / 393 72 / 274 modality, the filler 460 may include a second positive locating feature 480 in the circuit connection area 454. The locating features 478, 480 may prevent rotation of the blood component collection circuit 520 in the circuit connection area 454 and / or prevent the blood component collection circuit 520 from disengaging from the circuit connection area 454 of the filler 460.

[0110] In at least one embodiment, the packing 460 may include a collection insertion channel 466 configured to receive, and at least partially contain, a blood component collection bladder from the blood component collection assembly and, more specifically, the blood component collection circuit 520. The collection insertion channel 466 may be configured as a groove, slit, extending outward in a substantially spiral shape from a center of the packing 460. In at least one embodiment, the collection insertion channel 466 may follow a substantially spiral path that may include an initial spiral path portion extending outward from the center of the packing 460 to a substantially constant radius (e.g., approximately at the center of the packing 460) along a length from the periphery of the collection insertion channel 466.In any case, the path may be referred to in this document as a spiral path or a substantially spiral path. The collection insertion channel 466 may begin at a channel entrance 468 adjacent to the center of the filler body 464 and terminate at a channel end 472 adjacent to a point further from the center of the filler body 464. As shown in FIGS. 4G-4I, the collection insertion channel 466 may extend along a substantially spiral path 490 that runs from a point adjacent to the axis of rotation of the filler 430B to the end of channel 472. The substantially spiral path 490 may include a... Petition 870250078665, dated 03 / 09 / 2025, page 88 / 393 73 / 274 channel path deviation 476 at a point near or adjacent to the end of channel 472. This displacement of channel path 476 may extend the distance of the collection insertion channel 466 from the center of the filling body 464, thereby increasing the centripetal and centrifugal forces at the end of channel 472 of the collection insertion channel 466. In at least one embodiment, this displacement of channel path 476 may correspond to a critical entry and exit port at a radial maximum within a blood component collection bladder 536 that is inserted or disposed, at least partially, within the collection insertion channel 466 of the filling 460. In at least one embodiment, the filling 460 may include one or more filling balance protrusions 482 disposed on, within, or around a portion of the filling body 464.These filling balance protrusions 482 can provide axial balance (e.g., about the axis of rotation of the filling 430B) filling 460, especially when the collection insertion channel 466 includes a collection bladder for blood components and fluid (e.g., blood, blood components, etc.).

[0111] FIG. 4I is a schematic plan view of a substantially spiral-shaped receiving channel, or collection insertion channel 466, for a fill 460 according to at least one exemplary embodiment of the present disclosure. The schematic plan view shows a first distance, R1, from the collection insertion channel 466 to a center of the fill body 464 (e.g., adjacent to the rotation axis of the fill 430B, etc.) at a first point along the substantially spiral path 490 and a second distance, R2, from the collection insertion channel 466 to the center of the fill body 464 passing through a point adjacent to the deviation of the channel path 476. As illustrated in FIG. 4I, the second distance, R2, is farther from the center of the fill body 464 than Petition 870250078665, dated 03 / 09 / 2025, page 89 / 393 74 / 274 the first distance, R1. This increase in distance may provide higher centripetal and centrifugal forces in the channel at a point near or at the end of the channel 472 than at any other point along the substantially spiral path 490. In at least one embodiment, the end of the blood collection bladder may substantially coincide with the end of the channel 472, providing the greatest blood separation forces at the bladder end.

[0112] FIGS. 4J-4L show various elevation sections of the filler 460 and, more specifically, of the collection insertion channel 466 and the filling insertion chamber 492 disposed within the filler body 464. In at least one embodiment, the collection insertion channel 466 may include a cross-section, or shape, that substantially follows the substantially spiral path 490 in the filler body 464. The collection insertion channel 466 may include an insertion groove configured to receive a substantially flat or empty blood component collection bladder. The blood component collection bladder may be inserted into the collection insertion channel 466 and a filling insertion chamber 492 may be formed in the filler body 464 along the substantially spiral path 490.The filler insertion chamber 492 may be defined by one or more side walls 494, 496 forming a cavity that follows a substantially spiral path 490. As shown in FIG. 4K, the filler insertion chamber 492 includes an inner chamber wall 494 separated at a distance from at least one outer chamber wall 496. The filler insertion chamber 492 may be formed in the filler 460 by 3D printing of the filler 460 and / or by some other metal or plastic forming operation or operations (e.g., casting, molding, forming, etc.). In at least one embodiment, the chamber of... Petition 870250078665, dated 03 / 09 / 2025, page 90 / 393 75 / 274 Filling Insertion 492 may include one or more insertion guide features 498. These insertion guide features 498 may be configured to guide, locate, and / or seat a blood component collection bladder within the filling insertion chamber 492 of the filling 460. Although shown as a chamfered or inlet feature of the filling insertion chamber 492, the insertion guide feature 498 may include one or more radii, chamfers, slopes, tapers, exit angles, receptacles, grooves, and / or other molded materials configured to direct and / or guide a portion of an inserted blood component collection bladder.

[0113] FIG. 4L shows different states of fluid collection bladders (e.g., blood component collection bladders, etc.) arranged within the collection insertion channel 466 and the filling insertion chamber 492 of the filler 460. As described above, a blood component collection bladder can be inserted into the collection insertion channel 466 in a substantially flat or empty state, S1. In the substantially flat state, S1, the blood component collection bladder can be sized to enter the upper opening of the collection insertion channel 466 and be held in a pre-filled condition within the filling insertion chamber 492. When the filler 460 begins to rotate and separate the blood components from the blood supplied by a donor 102, the blood component collection bladder can expand from the first substantially flat state, S1, to an expanded or filled state, S2.In at least one embodiment, the blood component collection bladder may expand with blood and / or blood components until the walls of the blood component collection bladder come into contact with the walls 494, 496 of the filling insertion chamber 492. In at least one embodiment, the shape... Petition 870250078665, dated 03 / 09 / 2025, page 91 / 393 76 / 274 of the filling insertion chamber 492 can be designed to optimize the amount of fluid (e.g., maximize fluid volume while minimizing the amount of material for filling 460) that can be collected and / or separated in the filling insertion chamber 492. EXAMPLE OF A BLOOD COMPONENT COLLECTION KIT

[0114] FIGS. 5A-5H illustrate a blood component collection set 500 prepared according to at least one embodiment of the present disclosure. The blood component collection set 500 includes various connections which include, for example, tubing and connectors. For example, as illustrated, the blood component collection set 500 may include one or more tubing, such as cassette inlet tubing 108A, circuit inlet tubing 108B, anticoagulant tubing 110, circuit outlet tubing 112, saline tubing 116 and / or plasma tubing 120, and also one or more connectors, such as tubing connector 106 and / or Y-connector 280 for saline and plasma tubing.The blood component collection set 500 may also include one or more other connectors, such as a first tubing fitting 504, a second tubing fitting 508, a bag fitting 512, a static system circuit connector 528, and / or a filling circuit connector 532. The various connections can fluidly connect the soft cassette 340 and the blood component collection circuit 520.

[0115] One or more tubing sections, including cassette inlet tubing 108A, circuit inlet tubing 108B, anticoagulant tubing 110, circuit outlet tubing 112, saline tubing 116 and / or plasma tubing 120 (collectively referred to as “the tubing”), each having a central lumen configured to conduct fluid through it. The tubing may include one or more polymeric materials, including, for example, polyvinyl chloride (PVC), chloride of Petition 870250078665, dated 03 / 09 / 2025, page 92 / 393 77 / 274 plasticized polyvinyl, polyethylene, ethylene vinyl acetate (EVA), rubbers, copolymers and combinations thereof.

[0116] One or more connectors, including tubing connector 106, Y-connector 280 for saline and plasma tubing, first tubing fittings 504, second tubing fitting 508, bag fitting 512, static system circuit connector 528 and / or filling circuit connector 532 (collectively referred to as “the connectors”), may be configured to fluidly interconnect tubing and / or fluidly interconnect tubing and other medical accessories and / or fluidly interconnect tubing and needles or tips. For example, the connectors may be inserted into the central lumen of the respective tubing and / or attached to the outside of the respective tubing and / or the bag fitting 512 may be configured to be inserted into a receiving bag, such as the saline bag 118.In at least one embodiment, the connectors may include various accessories, including, for example, Luer fittings, twist-on fittings and / or other small-diameter couplings, to provide universal and / or reliable interconnections for establishing fluid connections.

[0117] As illustrated, the blood component collection circuit 520 may include a flexible circuit 524 disposed between the system static circuit connector 528 and the filling circuit connector 532. The static circuit connector 528 may be attached to the flexible circuit 524 and / or to a blood component collection bladder 536, as discussed further below, by a mechanical lock, which may be formed with a photocurable adhesive. The flexible circuit 524 may be configured as a hollow flexible tubing configured to receive and / or contain at least a portion of the circuit inlet tubing 108B and the circuit outlet tubing 112. In at least one embodiment, the flexible circuit 524 Petition 870250078665, dated 03 / 09 / 2025, page 93 / 393 78 / 274 may include a thermoplastic elastomer with enhanced flexibility to transmit torsion from a first end of the flexible circuit 524 toward a second distal end. These thermoplastic elastomers may provide the flexibility of rubber while maintaining the strength and torque characteristics of plastics. Examples of thermoplastic elastomers may include, for example, copolyester, DUPONT™ HYTRE thermoplastic elastomers l®, EASTMAN NEOSTAR™ elastomers, CELANESE RITEFLEX® elastomers, TOYOBO PELPRENE® and / or other similar brands of elastomers that offer high flexibility and strength characteristics.

[0118] In at least one embodiment, the blood component collection circuit 520 may include a blood component collection bladder 536. The blood component collection bladder 536 may have a first bladder circuit end 540A and a second bladder-free end 540B. The blood component collection bladder 536 may include a first collection flow chamber 544 extending between the bladder circuit end 540A and the bladder-free end 540B and connected to the flexible circuit 524 via the filling circuit connector 532. For example, in at least one embodiment, fluid may flow between the circuit inlet tubing 108B and the first collection flow chamber 544 through the flow path defined by the flexible circuit 524, the system static circuit connector 528, and the filling circuit connector 532.The free end of bladder 540B of the first collection flow chamber 544 may include a flow chamber transition 548, and the fluid flowing from the circuit end of bladder 540A to the free end of bladder 540B through the first collection flow chamber 544 may enter a second collection flow chamber 552 through the flow chamber transition 548. The second collection flow chamber 552 may be connected to the flexible circuit. Petition 870250078665, dated 03 / 09 / 2025, page 94 / 393 79 / 274 524 via the filling circuit connector 532. For example, in at least one embodiment, the fluid may flow between the circuit outlet piping 112 and the second collection flow chamber 552 via a flow path defined by the flexible circuit 524, the system static circuit connector 528 and the filling circuit connector 532.

[0119] In at least one example embodiment, as illustrated in FIG. 5B, the flexible circuit 524 may include a first distinct path 509 that is configured to receive the circuit inlet tubing 108B and a second distinct path 510 that is configured to receive the circuit outlet tubing 112. For example, in at least some example embodiments, at least a portion of the circuit inlet tubing 108B may be retained within the first path 509 of the flexible circuit 524 and connected to the first collection flow chamber 544 at the bladder circuit end 540A via the filling circuit connector 532. Additionally, or alternatively, at least a portion of the circuit outlet tubing 112 may be retained within the second path 510 of the flexible circuit 524 and connected to the second collection flow chamber 552 at the bladder circuit end 540A via the filling circuit connector 532.In this way, the fluid enters the blood component bladder 536 through the first collection flow chamber 544, where the fluid can be separated (for example, into one or more blood components) and transported along the second collection flow chamber 552 to the circuit outlet tubing 112 retained within the second path 510 of the flexible circuit 524.

[0120] As illustrated, the first collection flow chamber 544 can be separated from the second collection flow chamber 552 by means of a flow chamber separator 542. In at least one embodiment, the flow chamber separator Petition 870250078665, dated 03 / 09 / 2025, page 95 / 393 80 / 274 542 may be a sealed (e.g., heat-sealed) portion of the blood component collection bladder 536. For example, in at least one exemplary embodiment, the blood component collection bladder 536 may include, and may be prepared from, one or more overlapping and sealed layers of material. The material layers may include one or more polymeric materials. For example, in at least one exemplary embodiment, the material layers may include polyvinyl chloride (PVC), plasticized polyvinyl chloride, polyethylene, ethylene vinyl acetate (EVA), thermoplastics, thermoplastic elastomer, copolymers, and combinations thereof.

[0121] The material layers can be shaped (e.g., cut or otherwise molded, etc.) and sealed along one or more edges to form the blood component collection bladder 536. As illustrated in FIGS. 5C and 5D, the flow chamber separator 542 can be formed in the blood component collection bladder 536 by sealing one or more material layers to one or more other material layers, and / or one or more first portions of a single material layer to one or more second portions of the single material layer, along one or more pre-selected paths. For example, as illustrated in FIG. 5D, which shows the blood component collection bladder 536 before sealing, the flow chamber separator 542 can be formed as a sealed material region by joining a material from the first side of the bladder 536A to a material from the second side of the bladder 536B.The material on the first side of the bladder 536A and the material on the second side of the bladder 536B can also be sealed at one or more ends 554A, 554B to form an upper and lower part of the blood component collection bladder 536. For comparison, FIG. 5C shows the blood component collection bladder 536 after sealing. As illustrated in FIGS. 5A and 5B, the seal defining the flow chamber separator 542 does not extend beyond. Petition 870250078665, dated 03 / 09 / 2025, page 96 / 393 81 / 274 the entire length of the blood component collection bladder 536 and therefore defines the transition of the flow chamber 548 so that fluid can pass between the first collection flow chamber 544 and the second collection flow chamber 552.

[0122] Once formed, the bladder width (WB) can correspond to the width of the first collection flow chamber 544 and / or the second collection flow chamber 552 in an unexpanded state (S1) (see FIG. 4L). During operation, as fluid fills at least a portion of the blood component collection bladder 536, the bladder width (WB) can increase in dimension from the resting dimension illustrated in FIG. 5C. For example, in at least one example embodiment, the bladder width (WB) can increase substantially to the size of the filling insertion chamber 492 of the filling 460. In at least one example embodiment, the sealed and welded portions of the blood component collection bladder 536 can be supported on the filling 460. For example, as illustrated in FIGS. In the 5G and 5H models, the upper part of the 460 fill can support the two upper seals 554A and 542, and the lower part of the 460 fill can support the lower seal 554B.

[0123] In at least one embodiment, the blood component collection circuit 520 may include one or more locating features (also called key features) 530A, 530B that are configured to help positively locate portions of the blood component collection circuit 520 relative to the apheresis system 200 and, more specifically, to the centrifuge assembly 400 fill 460. For example, as illustrated, the blood component collection circuit 520 may include a first locating feature 530A at or near the static circuit connector of the system 528 and / or a second locating feature 530B at or near the fill circuit connector 532. The locating features Petition 870250078665, dated 03 / 09 / 2025, page 97 / 393 82 / 274 530A, 530B can be configured as a key, a tab, and / or other material protrusion extending from the respective connector 528, 532. In at least one embodiment, the second locating feature of connector 530B may include features that interconnect (e.g., mate) with the first positive locating feature 478 and / or the second positive locating feature 480 of the circuit connection area 454 in the fill 460.

[0124] FIGS. 5E-5H are various perspective views of the blood component collection circuit 520 in a flexed state and also illustrate the flexed blood component collection bladder 536 of the blood component collection circuit 520 as inserted into the filling 460 of the centrifuge assembly 400. The various components of the blood component collection circuit 520 may be flexible and / or capable of being formed or shaped by the application of force. In at least one embodiment, this flexibility may be elastic so that the forming of the various parts of the blood component collection circuit 520 does not permanently deform the components.

[0125] FIG. 5E illustrates the blood component collection circuit 520 in a flexed state. For example, in FIG. 5E, the flexible circuit 524 is shown elastically bent along its length and the blood component collection bladder 536 is shown following a series of curves along its length. However, the flexible circuit 524 supplies fluids to the blood component collection bladder 536, for example, via the circuit inlet tubing 108B, and / or withdraws fluids from the blood component collection bladder 536, for example, via the circuit outlet tubing 112, while one or more of the various components of the blood component collection circuit 520 are in a flexed state. Petition 870250078665, dated 03 / 09 / 2025, page 98 / 393 83 / 274

[0126] In at least one embodiment, the blood component collection circuit 520 may be pre-formed, for example, as illustrated in FIG. 5F, to fit into the collection insertion channel 466 of the centrifuge assembly 400 filler. The pre-formation may include twisting the blood component collection bladder 536 of the blood component collection circuit 520 so as to coincide with the substantially spiral path 490 of the collection insertion channel 466. Once pre-formed, the features of the blood component collection circuit 520 may be aligned with one or more features of the filler 460, as illustrated in FIG. 5G.For example, in at least one embodiment, the filling circuit connector 532 of the blood component collection circuit 520 may be aligned with the circuit connection area 454 of the filler 460 such that the second connector locating feature 530B is aligned to engage with the first positive locating feature 478. Additionally, or alternatively, the blood component collection bladder 536 may be shaped or formed (e.g., manually or automatically) to match the substantially spiral path 490 of the collection insertion channel 466 in the filler 460. In at least one embodiment, this shaping or forming may include aligning the free end of the bladder 540B of the blood component collection bladder 536 with the channel end 472 of the collection insertion channel 466 in the filler 460.When the components are generally aligned with each other, the blood component collection circuit 520 can be moved in one direction toward the collection insertion channel 466 and the circuit connection area 454, as shown in FIG. 5G. In at least one embodiment, when the filling circuit connector 532 is moved toward and into the circuit connection area 454 of the filler 460, the first. Petition 870250078665, dated 03 / 09 / 2025, page 99 / 393 The positive locating feature 478, 84 / 274, can interconnect and / or retain the second locating feature 530B of the filling circuit connector 532 of the blood component collection circuit 520. This interconnection can prevent the filling circuit connector 532 from rotating relative to the filler 460. In at least one embodiment, the interconnection can keep the filling circuit connector 532 of the blood component collection circuit 520 within the connection area of ​​the filling circuit 454. FIG. 5H illustrates the blood component collection circuit 520 loaded into the filler 460. The system static circuit connector 528 and the filling circuit connector 532 can work together to transfer the torque applied to the flexible circuit 524 to the blood component collection bladder 536 and the filler 460.

[0127] In at least one embodiment, the fluid (e.g., blood and / or blood components, etc.) in the blood component collection bladder 536 contained in the filling insertion chamber 492 of the filler 460 can travel in one direction toward the free end of the bladder 540B along the first collection flow chamber 544 around one end of the flow chamber separator 542 (e.g., following the direction of movement of the blood component 546) and into the second collection flow chamber 552. In this example, the blood components (e.g., plasma, etc.) can be forced back along the substantially spiral path 490 toward the center of the filler body 464 along the second collection flow chamber 552 and through the circuit outlet tubing 112 (e.g., to a plasma collection bottle 122). EXAMPLE OF CENTRIFUGE ASSEMBLY IN CIRCUIT LOADING STATE

[0128] FIGS. 6A-6C are schematic views in section of a Petition 870250078665, dated 03 / 09 / 2025, p. 100 / 393 85 / 274 centrifuge assembly 400 in various circuit loading states according to at least one embodiment of the present disclosure. The centrifuge assembly 400 as illustrated in FIGS. 6A-6C may correspond to the centrifuge assembly 400 described above and especially in conjunction with FIGS. 4D-4F. In particular, FIG. 6A shows a schematic sectional view of a first circuit loading state, FIG. 6B shows a schematic sectional view of a second circuit loading state, and FIG. 6C shows a schematic sectional view of a second circuit loading state for the centrifuge assembly 400.

[0129] In FIG. 6A, the centrifuge assembly 400 is shown in an open, circuit-loading position, where the upper housing 404B has been rotated 180 degrees from a closed or operational position. This open position may correspond to the position of the centrifuge assembly 400 shown in FIG. 4F. However, in FIG. 6A, a blood component collection circuit 520 was inserted into the filler 460 and the filler circuit connector 532 is interconnected to the circuit connection area 454 of the filler body 464. The other end of the blood component collection circuit 520 is connected to the fixed circuit connection 402 via the system static circuit connector 528. In this first circuit loading state, the flexible circuit 524 is fixed so as not to rotate in the fixed circuit connection 402, but rotates, in unison, with the filler 460 in the circuit connection area 454.

[0130] In FIG. 6B, the centrifuge assembly 400 is shown in a partially closed position, where the upper housing 404B is being moved from the open position to a closed or operational position. As the upper housing 404B rotates, the flexible circuit 524 can move to a rest position relative to the centrifuge assembly 400. Although the circuit Petition 870250078665, dated 03 / 09 / 2025, page 101 / 393 86 / 274 flexible 524 is rotationally fixed in the connection of the fixed circuit 402, the filling 460 can be free to rotate around the rotation axis of the filling 430B (for example, restricted only by the rotationally fixed flexible circuit 524).

[0131] In FIG. 6C, the centrifuge assembly 400 is shown in a closed or operational position, where the upper housing 404B can be locked into the lower housing 404A (so that the lower housing 404A and the upper housing 404B can rotate in unison around the axis of rotation of the centrifuge 430). In this position, the flexible circuit 524 can pass from the connection area of ​​the filling circuit 454 through the access gap to the circuit 436 of the split centrifuge housing 404 to the connection of the fixed circuit 402. In at least one embodiment, the flexible circuit 524 can be free to move within the access gap to the circuit 436 with or without contact with one or more portions of the split centrifuge housing 404.In this position, since the centrifuge assembly 400 can rotate around the axis of rotation of the centrifuge 430, the flexible loop 524 rotationally fixed to the connection of the fixed loop 402 can twist along the length of the flexible loop 524, thus rotating the packing 460 within the centrifuge assembly 400 (e.g., along the axis of rotation of the centrifuge 430). As foreseen above, the rotation of the packing 460 relative to the centrifuge assembly 400 can be in a ratio of 2:1. For example, as the centrifuge assembly 400 rotates one revolution, the rotationally fixed flexible loop 524 (e.g., fixed at the fixed loop connection 402) twists in the loop connection area 454 (e.g., trying to disentangle itself from being twisted by the rotation of the centrifuge assembly 400, etc.), thus rotating the packing 460 in the same direction of rotation as the centrifuge assembly 400, but by substantially two revolutions.This rotation of the filling. Petition 870250078665, dated 03 / 09 / 2025, page 102 / 393 87 / 274 460, by twisting the flexible circuit 524 along its length, does not require any gearing between the centrifuge assembly 400 and the filling 460. EXAMPLE OF CENTRIFUGE ASSEMBLY IN LOADED CIRCUIT STATE

[0132] FIGS. 7A-7B show schematic views of the centrifuge assembly 400 automatically loading a circuit into an operational position (e.g., blood separation) for centrifugation. The centrifuge assembly 400 shown in FIGS. 7A-7B may correspond to the centrifuge assembly 400 as discussed previously and / or as described in conjunction with FIGS. 4A-4F and / or FIGS. 6A-6C. Once the blood component collection circuit 520 has been loaded into the centrifuge assembly 400, as illustrated in FIG. 6C, the flexible circuit 524 can be automatically loaded into an engaged circuit position 520B, as shown in FIGS. 7A-7B.

[0133] In at least one embodiment, when the upper housing 404B is locked into the lower housing 404A, the flexible circuit 524 can go from the connection area of ​​the circuit 454 of the filler 460 to the connection of the fixed circuit 402 of the apheresis system 200. Although the flexible circuit 524 can be rotationally fixed to the fixed circuit connection 402 in the static circuit connector of the system 528, the flexible circuit 524 passing through the access gap to the circuit 436 in the split centrifuge housing 404 may not initially be held, or at least partially captured, by the rotational position guide of the circuit 424 and / or other features of the centrifuge assembly 400. This state of the flexible circuit 524 relative to the rotational position guide of the circuit 424, or circuit arm, may correspond to an uncaptured circuit state 700A. In other words, the flexible 524 circuit can be oriented at some angle (α) relative to the position guide. Petition 870250078665, dated 03 / 09 / 2025, p. 103 / 393 88 / 274 rotational circuit 424, to the circuit position stop plate 704 and / or to one or more circuit torsional support bearings 708 or bearing assemblies. In at least one embodiment, the circuit torsional support bearing 708 may correspond to the bearings 417 described in conjunction with FIGS. 4B-4C. A circuit containment area, or channel, may be formed by the circuit position stop plate 704 and / or one or more circuit torsional support bearings 708 arranged along a length of the upper housing 404B. In at least one embodiment, this orientation may be designed to allow access and / or ease of loading during the circuit loading described in conjunction with FIGS. 6A—6C.

[0134] As the centrifuge assembly 400 is rotated in a circuit rotation and filling direction 712 around the centrifuge rotation axis 430, the flexible circuit 524 can move from the uncaptured circuit state 700A to the captured circuit state 700B shown in FIG. 7B. This rotation can be caused by an operator rotating the centrifuge assembly 400 and / or the packing 460 in the direction of rotation of the circuit and packing 712 and / or by the rotor and motor assembly 414 causing the centrifuge assembly 400 to rotate about the axis of rotation of the centrifuge 430. In at least one embodiment, as the flexible circuit 524 rotates in the direction of rotation of the circuit and packing 712, an outer portion of the flexible circuit 524 may come into contact with a circuit position stop plate 704, or other rotational stop surface, of the circuit rotational position guide 424.

[0135] While the flexible circuit 524 is held, or at least partially contained, in the circuit rotational position guide 424, a portion of the flexible circuit 524 may move within one or more circuit torsional support bearings. Petition 870250078665, dated 03 / 09 / 2025, p. 104 / 393 89 / 274 708. As described above, the flexible circuit 524 can be rotationally fixed to the fixed circuit connection 402 by means of the first locating feature of the system's static circuit connector 530A associated with the blood component collection circuit 520. This rotationally fixed connection prevents the flexible circuit 524 from rotating relative to the apheresis system 200 at the fixed circuit connection 402. The other end of the flexible circuit 524 can be interconnected in the connection area of ​​the filler 460, where the end can move with the filler 460 and / or centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the direction of rotation of the circuit and filler 712, the forces of the flexible circuit 524 attempting to unravel, or prevent bonding, rotate the filler 460 and the end of the flexible circuit 524 attached to it. he.

[0136] In any case, once the fluid separation methods described in this document have been completed, the centrifuge assembly 400 can be stopped to rotate and the split centrifuge housing 404 can be opened to remove the disposable elements of the blood component collection assembly 500 from the centrifuge assembly 400. In some cases, the flexible circuit 524 can be moved from the captured circuit state 700B shown in FIG. 7B to the uncaptured circuit state 700A shown in FIG. 7A by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the direction of rotation of the circuit and filler 712. EXAMPLE FUNCTIONAL DIAGRAM OF AN EXAMPLE APHERESIS SYSTEM

[0137] A functional diagram of the 200 apheresis system may be as shown in FIG. 8 according to at least one embodiment of the present disclosure. The description presented in this document shows the components described above, in FIGS. 1-7B, in a functional diagram to describe the Petition 870250078665, dated 03 / 09 / 2025, p. 105 / 393 90 / 274 operation of system 200 for extracting plasma or other blood components from the whole blood of a donor 102 during an apheresis procedure or process.

[0138] System 200 may include an anticoagulant pump (AC) 216. The AC pump 216 pumps fluid in the AC tubing 110 from the AC bag 114. The AC pump 216, the AC tubing 110 and / or the AC bag 114 may be as described above. The AC tubing 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tubing 110. The AC ADS 804 may be of the same or similar type and / or function to sensor 284 and / or sensor 312, described above. The AC 110 tubing can cross and be fluidly connected to the donor feed tubing 104 and the cassette inlet tubing 108A at the tubing connector 106. Tubing connector 106 can be any type of connection between tubing 110, 104, and / or 108A, as described previously.

[0139] Donor feed tubing 104 exits donor 102, where donor 102 can be punctured with a lumen needle or other device, allowing whole blood to flow from donor 102 to the apheresis system 200 and allowing blood components to flow back to donor 102. Tubing 108A can proceed to the flexible cassette 340. Additionally, a donor air detection sensor 312 can be placed on or inside tubing 108A to detect the presence of fluid and / or air within tubing 108A.

[0140] As explained previously, the flexible cassette 340 may include the first cassette port 360A, which may function as, include, and / or be substantially close to a connector or Y-section, or branches, that separates the 108A tubing into the first branch 358A and the first tubing section 368A (the Y-section will be designated by the reference character 360A). The two tubing sections 358 and 368 may Petition 870250078665, dated 03 / 09 / 2025, page 106 / 393 91 / 274 to be reconnected to the second cassette port 360B, which may also function as, include, and / or be substantially close to a second connector or Y-section (the second Y-section will be designated by the reference character 360B). Tubing 358 is bisected by the fluid sensor 316, which separates tubing 358 into the first bypass branch 358A and the second bypass branch 358B. Similarly, tubing 368 is bisected by the drip chamber 354, which separates tubing 368 into a first tubing section 368A and a second tubing section 368B.

[0141] The first section of piping 368A may include a first fluid control valve 320A. The second piping 368B may also include a second fluid control valve 320B. The first branch line 358A may similarly include an extraction fluid control valve 320C. Thus, the various sections of piping 368A, 358A, 358B and 368B may be isolated by valves 320A, 320B and / or 320C based on the system configuration 200 and depending on the operation of system 200.

[0142] A drip chamber 354 may be disposed between the first pipe section 368A and the second pipe section 368B. The drip chamber 354 may collect a volume of whole blood and / or blood with high hematocrit (blood with a high percentage of red blood cells) depending on the operation of system 200, as described below. The fluid sensor 316, as described above, may be disposed between the first bypass branch 358A and the second bypass branch 358B.

[0143] The 108B inlet pipe can connect to the second cassette port 360B and can connect the soft cassette 340 to the flexible circuit 524. The 108B inlet pipe can also include a sensor 808, arranged on or inside the 108B pipe, placed with the 108B pipe before connecting to the system static circuit connector 528 of the flexible circuit. Petition 870250078665, dated 03 / 09 / 2025, page 107 / 393 92 / 274 524. The pressure sensor (CPS) 808 can detect one or more of the following, but is not limited to: pressure, presence of fluid or air, and / or possibly other fluid characteristics in the tube 108B. Additionally, an extraction pump 208 can cause fluid to be pumped through the tubing 108B away from the soft cassette 340 or into the soft cassette 340.

[0144] Two or more different tubes may be connected to the flexible circuit 524 by means of the system static circuit connector 528 and supply fluid to, or receive fluid from, the blood component collection bladder 536. An outlet tube 112 exits the system static circuit connector 528 from the flexible circuit 524. This outlet tube 112 may also include another line sensor 812 disposed on or within it to detect fluid, air, cell concentration, color and / or color change in the fluid coming from the flexible circuit 524; the line sensor 812 may be of the same or similar type and / or function to the sensors 804, 312, 320, 808 and / or 284 described above. A second CPS 816 sensor or fluid sensor may also be placed in line 112. The 816 sensor may detect one or more of the following, but not limited to: presence or absence of fluid, pressure within pipe 112, and / or other fluid characteristics in pipe 112.Similarly, sensor 816 may be the same or similar in type and / or function to sensors 804, 312, 320, 808, 812 and / or 284 described previously.

[0145] The outlet tubing 112 can then flow to a plasma air detection sensor 284 before the Y-connector 280 of the saline and plasma tubing separates the outlet tubing 112 into the saline tubing 116 and the plasma tubing 120. The return pump 212 can interact with the outlet tubing 112 and can cause fluid or air to flow through the outlet tubing 112 from the flexible circuit 524 or from a saline bag 118 and / or a collection bottle. Petition 870250078665, dated 03 / 09 / 2025, page 108 / 393 93 / 274 plasma 122.

[0146] The saline bag 118 and associated tubing may be as described above and may deliver saline solution through the system 200 back to the donor 102. A saline flow control valve 288 may isolate the saline bag 118 from the rest of the system 200. In addition, a plasma collection bottle 122 may receive plasma from the flexible circuit 524 when processed or separated from whole blood. The plasma collection bottle 122 may be selectively isolated from the system by the plasma flow control valve 286. ELECTRICAL AND CONTROL SYSTEM

[0147] One embodiment of the electrical and control system 900 that controls the functions of the apheresis system 200 may be as shown in FIG. 9 according to embodiments of the present disclosure. The control system 900 may include one or more nodes, which may include various hardware, firmware and / or software configured to control and / or communicate with the mechanical, electromechanical and electrical components of the apheresis system 200.

[0148] Each node can function to control a different part of the apheresis system 200. For example, the control system 900 may include a cassette node 904, which may be a flexible cassette assembly system, and a centrifuge node 908, which may be a centrifuge system, which may control or communicate with the components of the blood component collection assembly 500 (and the associated mechanical or hardware components that interface with the flexible cassette assembly 300) and the centrifuge assembly 400 (and the mechanical or hardware components associated with it), respectively. The cassette node 904 and the centrifuge node 908 may be in wireless communication or via some other electrical or data connection. In some configurations, the cassette node 904 and the centrifuge node 908 may be separate nodes that may be two portions Petition 870250078665, dated 03 / 09 / 2025, page 109 / 393 94 / 274 of a single node 902 or system. Thus, each of the cassette nodes 904 and the centrifuge node 908 may have the same physical hardware operating to control different functions. In at least one embodiment, the single node 902 may include physical hardware for both the cassette node 904 and the centrifuge node 908, or the cassette node 904 may include physical hardware separate from the physical hardware of the centrifuge node 908. An example of the cassette node 904 may be as described in conjunction with FIG. 10; a centrifuge node 908 may be as described in conjunction with FIG. 11.

[0149] Each of the cassette nodes 904 and the centrifuge node 908 can be in communication with one or more sensors 916, 920, and / or 924. There may be more or fewer sensors than those shown in FIG. 9, as represented by the ellipse 928. Each of the cassette nodes 904 and the centrifuge node 908 can communicate directly with each sensor 916-924 or can communicate with multiple sensors 916-924 via bus 912. Bus 912 can communicate via any type of communication protocol, such as Universal Serial Bus (USB), Universal Asynchronous Receive / Transmit (UART), or other types of bus systems or parallel communication connections. Thus, bus 912 can be optional, but it is shown as a possible communication platform for communication with the various sensors 916-924. The 916-924 sensors can be any type of sensor that can communicate information about light, fluid, presence of air, color, pressure, etc., as described in this document.Some of the 916-924 sensors may include sensors such as the 312 air detection sensor, the 316 fluid sensor, the 804 AC ADS sensor, the 808 pressure sensor, the 812 line sensor, the second 816 CPS sensor, and / or the 284 air detection sensor. The function of these 912-924 sensors may be as described below.

[0150] The 904 cassette node and the 908 centrifuge node can also communicate with one or more pump drives, motors Petition 870250078665, dated 03 / 09 / 2025, page 110 / 393 95 / 274 pump, etc. 936, 940, 944, simply called pumps. There may be more or fewer pumps than those shown in FIG. 9, as represented by the ellipse 948. The cassette node 904 and the centrifugal node 908 can communicate with the pumps 936-944 by means of direct wired or wireless communication or by means of a bus 932. The bus 932 can be a control area network (CAN) bus, USB or other type of bus architecture for communication with the pumps 936-944. The pumps 936-944 may include or be part of at least one of the extraction pumps 208, return pump 212 and / or AC pump 216, as described above. The function of the pumps 936-944 can be described as in this document.

[0151] An embodiment of the 904 cassette node may be as shown in FIG. 10 according to embodiments of the present disclosure. The 904 cassette node may include one or more 1004 controllers, a 1008 memory, a 1020 valve controller and / or communication interfaces for a CAN bus 1016, a UART 1012 or other types of buses. The 904 cassette node may include other hardware, firmware and / or software which are not shown for clarity.

[0152] The 1004 controller, also referred to here as the processor, can be any type of microcontroller, microprocessor, Field Programmable Gate Array (FPGA), Application-Specific Integrated Circuit (ASIC), etc. An example of a 1004 controller could be the NK10DN512VOK10 microcontroller, manufactured and sold by N9P USA, Incorporated, which is a 32-bit architecture microcontroller unit. Other types of controllers are possible. The 1004 controller can control other types of devices or direct the functions of other types of devices, such as valves, such as the first fluid control valve 320A, the second fluid control valve 320B, the extraction fluid control valve 320C, the plasma flow control valve 286, the Petition 870250078665, dated 03 / 09 / 2025, page 111 / 393 96 / 274 saline solution flow control valve 288 and pumps 936-944, etc. In addition, controller 1004 can communicate with various sensors 916-924 or other devices to receive or send information about the function of the apheresis system 200.

[0153] Other examples of processors or microcontrollers 1004, as described in this document, may include, but are not limited to, at least one of the Qualcomm® Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTE integration and 64-bit computing, Apple® A7 processor with 64-bit architecture, Apple® M7 motion coprocessors, Samsung® Exynos® series, Intel® Core™ processor family, Intel® Xeon® processor family, Intel® Atom™ processor family, Intel Itanium® processor family, Intel® Core® i5-4670K and i7-4770K 22nm Haswell, Intel® Core® i5-3570K 22nm Ivy Bridge, AMD® FX™ processor family, AMD® Vishera FX-4300 processors, The 32 nm FX-6300 and FX-8350, AMD® Kaveri, ARM® Cortex™-M, ARM® Cortex-A, and ARM92 6EJS™, and other equivalent industry processors, can perform computational functions using any known or future-developed standard, instruction set, libraries, and / or architecture.

[0154] Memory 1008 may be any type of memory, including random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disk (CD-ROM) read-only memory, optical storage device, magnetic storage device, any suitable combination of the foregoing, or other type of storage or memory device that stores and provides instructions for programming and controlling controller 1004. Memory 1008 may provide all types of software or firmware that program the functions of controller 1004, as described below.

[0155] The 1004 controller can communicate with one or more Petition 870250078665, dated 03 / 09 / 2025, page 112 / 393 97 / 274 valve controllers 1020. Each valve, such as the first fluid control valve 320A, the second fluid control valve 320B, the extraction fluid control valve 320C, the plasma flow control valve 286, the saline solution flow control valve 288, as described in this document, can be controlled by a valve controller 1020 and can be associated with a system component 200, as described in this document. The 1020 valve controller can provide the electrical signal, operating directive, or power to close or open any of the valves described herein, for example, the saline and plasma solution valve housing 276, the plasma flow control valve 286, the saline solution flow control valve 288, the first fluid control valve 320A, the second fluid control valve 320B, and / or the extraction fluid control valve 320C, etc.

[0156] The 1004 controller can also be connected to a 912, 932 bus (e.g., UART bus, CAN bus) or other buses by means of 1012, 1016 transceivers supplied outside the 1004 controller or integral to the 1004 controller. The 1012 UART transceiver can communicate with one or more 916-924 sensors or other devices. Similarly, the 1016 CAN bus transceiver can communicate with one or more 936-944 pump controllers or other devices. The 1012 UART transceivers and buses and the 1016 CAN bus transceivers are well known in the art and need not be explained in more detail in this document.

[0157] An embodiment of the centrifuge node 908 may be as shown in FIG. 11 according to embodiments of the present disclosure. The centrifuge node 908 may include the same types of components or similar types to the cassette node 904. For example, the centrifuge node 908 may include a controller 1104, Petition 870250078665, dated 03 / 09 / 2025, p. 113 / 393 98 / 274 a UART 1112 transceiver, etc. Similar to the 1004 controller, the 1104 controller can be any type of processor or microcontroller, for example, the NK10DN512VOK10 microcontroller unit with 32-bit architecture from N9P USA, Incorporated, as mentioned earlier, or other controllers, processors, etc., for example, the devices mentioned earlier.

[0158] The 1104 controller can communicate with the 916-924 sensors directly, via the 1112 UART transceiver, or via other buses or systems. The 1104 controller can also communicate with a 1124 brake controller that can brake or decelerate and stop the 400 centrifuge. Similarly, a 1104 controller can communicate with a 1116 motor transceiver that communicates with a motor power system or a motor controller that operates to rotate or spin the 400 centrifuge or control the speed setting or other function of the 400 centrifuge.

[0159] In some configurations, the controller 1104 can also communicate with a cuff controller 1120 that can change or set the pressure of a pressure cuff on a donor's arm during the apheresis process. Additionally, the controller 1104 can communicate with and / or control a strobe light 1114, which can be any light that flashes periodically in sync with the motor's rotation rate, so that an operator of the apheresis system 200 can see the filling operation 460, as described previously. Thus, the controller 1104 can communicate with the strobe light 1114 to change the flashing frequency of the strobe light 1114, the intensity of the strobe light 1114, etc.

[0160] As should be understood, the cassette node 904 and the centrifuge node 908 include additional components, as described in Atty. Document No. 18955-000019-US, entitled “METHODS AND Petition 870250078665, dated 03 / 09 / 2025, p. 114 / 393 99 / 274 SYSTEMS FOR HIGH-THROUGHPUT BLOOD COMPONENT COLLECTION, filed on August 3, 2021 and designated as Application No. 17 / 392804, the full content of which is incorporated herein by reference. EXAMPLE OF DATA CONTROL AND CODE READING METHODS

[0161] In at least one embodiment example, a data entry process, as illustrated in FIG. 12A, can be used to initialize an apheresis system 200 for each new donor 102. The data entry process can ensure that a target quantity or volume of plasma based on the donor's weight or other donor information is obtained. In addition, information such as the vial identification can be entered via the data entry process so that the apheresis system can record in memory an indication of which vial was used for which donor.

[0162] In at least one embodiment, the process of FIG. 12A may begin at 12:00, when the apheresis system 200 may be switched on and awaiting a new donor. The apheresis system 200 may include an integrated identification reader (e.g., RFID reader, barcode reader, etc.) 1221, as illustrated in FIG. 12B, configured to read a code (e.g., RFID tag, barcode, etc.) associated with a specific donor 102 and control operations of the apheresis system 200 based on the information read by the identification reader. The information may include, but is not limited to, individual donor data (e.g., body mass index (BMI), first-time donor, weight, height, etc.). This information may be used to provide faster and higher-quality donor experiences.The codes can also be used to label other equipment used during the donation process, such as a 1227 label on a 1224 vial used for plasma collection, as illustrated in FIG. 12C. Petition 870250078665, dated 03 / 09 / 2025, page 115 / 393 100 / 274

[0163] In 1203, the 1221 reader of the 200 apheresis system can be used to scan a barcode, QR code, or other type of image to receive data associated with a donor. In at least one embodiment, the 1221 reader can be configured to read RFID input. For example, the donor may use an identification card or other type of object that may contain one or more barcodes, QR codes, RFID, etc. By scanning the identification card or other type of object, the 200 apheresis system can be enabled to receive data related to the donor.

[0164] Barcodes (e.g., 1D, 2D, etc.) can be read by an integrated barcode scanner located on the front of the apheresis system. For example, when starting the apheresis procedure, a user can scan a donor ID (e.g., from a PDA, phone, tablet, etc.), a blood component collection kit (e.g., separation kit), and / or a plasma collection bottle sequentially without requiring further user input via the user interface. The system can be enabled to receive the information and confirm the data entry automatically and without human intervention. As can be seen, this automatic sequential data entry increases the speed of operation compared to conventional non-sequential entry.

[0165] The data received from the donor may include biological information such as age, weight, height, donor history, or other information that may be relevant to the donation process. The data received from the donor may be used to determine if the donor qualifies for the donation procedure and to determine specific settings that may be required for the donation procedure, such as an expected total amount of plasma or other information. For example, the donor's height and weight may be used to determine the donor's body mass. The donor's body mass may then Petition 870250078665, dated 03 / 09 / 2025, page 116 / 393 101 / 274 should be used to determine the target quantity or volume of plasma to be collected.

[0166] In at least one example of embodiment, the information can be portable between donation sites, 200 apheresis systems, sites, etc. The information can be stored in the form of a nomogram, for example, in a 2D barcode. In this way, a donor can carry a single form of identification between donation sites and each donation site can collect information about the donor, such as the time since the last visit.

[0167] The information stored in the nomogram and readable by the integrated identification reader may be limited to the information that the apheresis 200 system is permitted to collect (e.g., by privacy laws, health laws, etc.). In at least one embodiment, other private information may be stored in the 2D barcode, but may be encrypted or blocked so that it cannot be read by the integrated identification reader of the apheresis 200 system.

[0168] The apheresis system 200 can scan or read the barcode and then determine which operations to perform. For example, the barcode may contain information about the weight and height of donor 102, which can be used to determine the amount or volume of plasma that donor 102 can provide or donate. As can be seen, a donor 102 with a first weight may be authorized to donate a first amount of plasma, while a donor 102 with a second, heavier weight may be authorized to donate a second amount of plasma that is greater than the first amount. Additionally, the body mass of donor 102 can be used to determine the amount or volume of plasma that donor 102 can provide or donate. After the apheresis system 200 reads the barcode, the apheresis system 200 can adjust the settings based on the information and stop operations when the amount Petition 870250078665, dated 03 / 09 / 2025, page 117 / 393 102 / 274 required of plasma, etc., for collection.

[0169] The 200 apheresis system can also be enabled to record information that can be read by other apheresis systems at the same or other donation sites. For example, donor data can be stored on a network location. The 200 apheresis system can be enabled to send data such as donation results, current donor weight, date and / or time of donation, or other information.

[0170] In at least one embodiment, the apheresis system 200 may comprise one or more computer systems. For example, as will be discussed in greater detail below with regard to FIG. 16D, the apheresis system 200 may include one or more computer systems 1627 which may comprise a processor 1630, memory 1633, input / output devices 1636, one or more pump control systems 1639, one or more sensors 1642 and / or other elements, as may be appreciated.

[0171] In at least one embodiment, as will be discussed in greater detail below with regard to FIG. 16B, the apheresis system 200 may be enabled to communicate with a server 1621 via a network 1618, such as the Internet. In at least one embodiment, the apheresis system 200 may communicate with a local computer system, such as a computer at a donation site, which may be configured to communicate with the server.

[0172] In at least one embodiment, after receiving the data associated with the donor, the apheresis system 200 can confirm receipt of the donor-associated data by means of a feedback system, such as a graphical user interface (GUI) 1230, as illustrated in FIGS. 12B and 12D. In this way, a nurse, professional or other user of the apheresis system 200 can quickly verify whether the donor information has been correctly entered into the apheresis system 200. Petition 870250078665, dated 03 / 09 / 2025, page 118 / 393 103 / 274 In at least one embodiment, the feedback system may also or alternatively comprise a loudspeaker that can be configured to provide audible feedback.

[0173] In 1206, the apheresis system 200 can be configured to determine, based on the data associated with a donor, a donor identification. For example, the apheresis system 200 can be configured to identify, using the data received by the scanner 1221, whether the donor is associated with any donor ID information in a database or whether the donor is a new donor. In at least one embodiment example, the scanner 1221 can access donor information from a server or other computer system, locally or via a network connection.

[0174] Donor identification information accessed through a database may include information such as age, body mass, weight, height and / or a target volume, i.e., an expected amount of plasma or other donation fluid to be received from the donor.

[0175] At 12:09, the apheresis system 200 can receive data associated with a blood component collection set. The blood component collection set may comprise, for example, a soft cassette set, such as the soft cassette set 300, to be used during the donation process. The data associated with the blood component collection set may be received by the apheresis system 200 via a barcode, a QR code, an RFID chip, or another type of scannable object that may be placed on the blood component collection set. For example, each blood component collection set may be affixed with a label or sticker that may include a distinct barcode, QR code, RFID chip, or other type of scannable object. By scanning the label or sticker on the blood component collection set, the Petition 870250078665, dated 03 / 09 / 2025, page 119 / 393 The 104 / 274 apheresis system 200 can be enabled to record in memory which blood component collection set is being used for the current donation process. In this way, the apheresis system 200 can be enabled to associate the donor with a specific blood component collection set. Any data received during the scanning process can be recorded in memory and shared with a server or other type of computing system.

[0176] Data associated with the blood component collection kit may include a manufacturing date, the manufacturer's identity, and other information that may be useful for data processing purposes after the donation is complete. In at least one embodiment, data associated with the blood component collection kit received via scanning may be used to determine a blood component collection kit type. The blood component collection kit type may be used by the apheresis system to adjust one or more settings, such as flow rate or other information during the donation process.

[0177] In at least one embodiment, after digitization of the blood component collection set, a user of the apheresis system 200 may be enabled to receive confirmation of receipt of the blood component collection set information. For example, a graphical user interface 1230, as illustrated in FIG. 12D, may display an indication of whether data from a blood component collection set has been received. This graphical user interface 1230 may be used by an apheresis system operator during the apheresis system initialization process for a new donor. In at least one embodiment, instead of or in addition to displaying via a graphical user interface, the apheresis system may reproduce an audible sound through one or more loudspeakers or display lights of various colors. Petition 870250078665, dated 03 / 09 / 2025, page 120 / 393 105 / 274 to indicate that the data has been received.

[0178] In 1212, the method may comprise receiving, with the apheresis system 200, data associated with a plasma collection vial. For example, to initialize the apheresis system 200 for a new donor, a plasma collection vial may be required. After the donation, the plasma collection vial may be filled with the donated plasma. For data tracking purposes, it may be necessary to associate the plasma collection vial with the donor. For example, information linking the donor to the plasma collection vial may be stored in memory. For this reason, it may be necessary to record the identity of the plasma collection vial. In this way, a user of the apheresis system 200 may be enabled to scan a label, sticker, or other object on or printed on the plasma collection vial using the apheresis system 200. For example, as illustrated in FIG. 12C, a plasma collection vial 1224 can be affixed with an adhesive or label 1227.In some examples of product types, the 1227 sticker or label includes a QR code.

[0179] As in other steps, when receiving data from a plasma collection vial, the apheresis system 200 can confirm receipt of the data by means of a graphical user interface, loudspeaker, whiteboard or other feedback system.

[0180] At 12:15, the apheresis system can perform a plasma donation process based on the information received in the steps above. For example, apheresis system 200 can perform the plasma donation process using information about the donor's identity. Data received from the plasma collection vial and / or blood components can also be used during the plasma donation process.

[0181] For example, a flow rate during the plasma donation process can be controlled based on one or more parameters of the donor's body mass and weight, determined with Petition 870250078665, dated 03 / 09 / 2025, page 121 / 393 106 / 274 based on the received data associated with the donor. A volume of plasma collected may also be controlled based on one or more parameters of the donor's body mass and weight, determined based on the received data associated with the donor.

[0182] At 12:18, the process can end, at which point the donation process can continue with the extraction of donor fluids being completed. Any data received through the steps discussed above can be stored in memory and / or shared with one or more computer systems. For example, a database entry can be created for a specific donation, including information such as the amount or volume of plasma extracted from the donor, the donor's current weight, the time and / or date of the donation, and / or other information.

[0183] At least one example of an embodiment of the present disclosure includes a method comprising: receiving, with an apheresis system, data associated with a donor; determining, based on the data associated with a donor, a donor identification; receiving, with the apheresis system, data associated with a blood component collection kit; receiving, with the apheresis system, data associated with a plasma collection bottle; and performing, with the apheresis system, a plasma donation process from the donor identification, the data associated with the blood component kit and the data associated with the plasma collection bottle.

[0184] Aspects of the above embodiment include where the receipt of data associated with the donor comprises the digitization, with a scanner, of an image. Aspects of the above embodiment include where the scanner is disposed in the apheresis system. Aspects of the above embodiment include where the image is one of a one-dimensional barcode and a two-dimensional barcode. Aspects of the above embodiment include where the image is displayed on a user's device. Aspects of the above embodiment include where the receipt of data associated Petition 870250078665, dated 03 / 09 / 2025, page 122 / 393 107 / 274 to the donor comprises the digitization of an RFID. Aspects of the above embodiment include, after receiving the data associated with the donor, confirming receipt of the data associated with the donor by means of a feedback system. Aspects of the above embodiment include where the feedback system comprises one or more of a loudspeaker and a graphical user interface. Aspects of the above embodiment include determining, based on the data associated with the donor, that the donor is a new donor. Aspects of the above embodiment include determining, based on the data associated with the donor, one or more of a donor's body mass and weight. Aspects of the above embodiment include where receiving the data associated with the blood component collection kit comprises scanning, with a scanner, one or more images and an RFID tag attached to the blood component collection kit.Aspects of the above embodiment include, after receiving the data associated with the blood component collection set, confirming receipt of the data associated with the blood component collection set via a feedback system. Aspects of the above embodiment include where the feedback system comprises one or more of a loudspeaker and a graphical user interface. Aspects of the above embodiment include where receiving the data associated with the plasma collection bottle comprises scanning, with a scanner, one or more images and an RFID tag attached to the plasma collection bottle. Aspects of the above embodiment include, after receiving the data associated with the plasma collection bottle, confirming receipt of the data associated with the plasma collection bottle via a feedback system. Aspects of the above embodiment include where the feedback system comprises one or more of a loudspeaker and a graphical user interface.Aspects of the above modality include where a flow rate during the plasma donation process is controlled based on one or more factors: body mass and a... Petition 870250078665, dated 03 / 09 / 2025, page 123 / 393 108 / 274 Donor weight determined based on received data associated with the donor. EXAMPLE OF CALIBRATION, MAINTENANCE AND SERVICE OF APHERESIS SYSTEMS

[0185] The apheresis system 200 may comprise one or more devices, systems, and / or features that are configured to allow the apheresis system 200 to be calibrated in the field. For example, the apheresis system 200 may comprise one or more devices, systems, and / or features that are configured to allow the apheresis system 200 to be calibrated in the field. In other words, the apheresis system 200 can be calibrated after manufacture and after being installed at a donor processing site. Conventional systems offer no way to be calibrated in the field.

[0186] In at least one embodiment, the apheresis system 200 may be self-calibrating. The apheresis system 200 may comprise a pump and a syringe that utilizes pressure supplied by a compressor integrated into the apheresis system 200, for example, to set a calibration pressure. In other embodiments, the compressor may not be integrated into the apheresis system 200 and may be a separate component of the apheresis system 200. The apheresis system 200 may also include a test port configured to generate a known or calibration pressure using, for example, the pump and compressor. In at least one embodiment, the test port is positioned on a rear side of the apheresis system 200 adjacent to other ports, such as a pressure cuff connection that may alter or set the pressure of a pressure cuff on a donor's arm during the apheresis process, as set forth above with respect to FIG. 11.The tubing of a 520 blood component collection circuit, calibration tubing assembly, etc., can be connected or otherwise interconnected to the test port for testing and / or calibration. When. Petition 870250078665, dated 03 / 09 / 2025, page 124 / 393 Interconnected with the test port, the compressor 109 / 274 generates a known calibration pressure, and a pressure sensor in the 200 apheresis system can calibrate based on the pressure detected by the pressure sensor. For example, the known calibration pressure can be compared to the detected pressure, and the difference can be used to calibrate the pressure sensor. The pressure sensor can be located, for example, at the test port, or it can be located anywhere in the 200 apheresis system.

[0187] Calibration may also comprise the use of a calibration object with a known weight (such as, for example, a NIST weight) to verify and / or calibrate a holder, such as the retainer 1300 shown in FIG. 13A and / or the load cell assembly of the vial tray shown in FIGS. 15A-15C, which will be discussed in greater detail below. In at least one embodiment, the retainer 1300 may be configured to receive the plasma collection vial 122. The retainer 1300 may be disposed in the upper cover 210 of the housing 204 and may be similar to the plasma collection cradle 232C, as shown in FIG. 14A. The 1300 retainer may include a weight sensor configured to detect the weight of an object placed in the 1300 retainer. Thus, during a calibration, the calibration object can be placed in the 1300 retainer and the weight sensor can detect the weight of the calibration object.A difference between the known weight of the calibration object and the weight detected by the weight sensor may indicate that the weight sensor may need calibration (which may be triggered automatically by the difference) or maintenance. In at least one embodiment, if the difference is greater than a predetermined threshold, the 200 apheresis system may automatically trigger calibration of the weight sensor. In other embodiments, a notification may be generated to alert a user to calibrate the weight sensor if the difference is greater than the predetermined threshold.

[0188] Calibration and / or calibration tests may be Petition 870250078665, dated 03 / 09 / 2025, page 125 / 393 110 / 274 performed when one or more components are exchanged or swapped in the 200 apheresis system. For example, exchanging or replacing one or more pumps (e.g., pumps 208, 212, 216) may trigger calibration test(s). Calibration (whether pressure, sensors, weight, etc.) may be performed automatically if one or more components of the 200 apheresis system fail the calibration test(s). If the calibration of one or more components is unsuccessful, the 200 apheresis system may be locked and cannot be used until each component passes its respective calibration test.

[0189] Method 1302 for performing a calibration and calibration test illustrated by the flowchart in FIG. 13B may begin at 13:04. At the start of method 1302, one or more calibration tests may be performed or executed. The calibration test(s) may be triggered automatically by the exchange or replacement of one or more components (e.g., one or more sleds, sensors, pumps, etc.) of an apheresis system, such as the 200 apheresis system. In other embodiments, the calibration test(s) may be triggered by user input. In other embodiments, calibration tests may be performed prior to the use of the 200 apheresis system.

[0190] At 13:06, one or more system components (e.g., calibration pipes, sensors, pumps, etc.) may be automatically calibrated. Calibration may be triggered, for example, by the failure of at least one of the one or more tests performed in step 1304. In other example embodiments, calibration may be triggered by user input. Calibration may be performed using one or more calibration tools, such as a pump, a test port, a calibration object, or similar. Calibration may cause a user interface, such as a graphical user interface (GUI), to prompt the user to connect one or more calibration tools or components. Petition 870250078665, dated 03 / 09 / 2025, page 126 / 393 111 / 274 to perform the calibration.

[0191] It will be appreciated that steps 1304 and 1306 can be repeated (separately or together). For example, a component may fail a calibration test in step 1304, the component may be automatically calibrated in step 1306, and the component may be tested again in step 1304 to test whether the component was calibrated correctly.

[0192] The apheresis system 200 may also include one or more protocols to service the device. These protocols may include Calibration (described above), Automatic Testing (e.g., testing limits and full range), Fluid Operation (with actual parameters), and / or similar. In at least one embodiment, a saline check may be performed. In such embodiments, the apheresis system 200 may comprise a weight sensor configured to detect the weight of the plasma collection bottle 122. The saline solution may be moved from the saline bag 118 to the plasma collection bottle 122, and a change in the weight of the plasma collection bottle 122 may be detected by the weight sensor. This change in weight indicates that the saline solution is flowing properly from the saline bag 118, through the saline tubing 116, and into the plasma collection bottle 112.In at least one embodiment, a disposable test may be performed to check for leaks in the blood component collection set 500. In such embodiments, the apheresis system 200 may include a pump configured to create a vacuum in the blood component collection set 500. The apheresis system 200 may also include a sensor to detect such leaks in the blood component collection set 500. In at least one embodiment, a centrifuge test may be performed to test the centrifuge assembly 400. In such embodiments, a motor of the rotor and motor assembly 414 may be activated to validate proper rotation of the assembly. Petition 870250078665, dated 03 / 09 / 2025, p. 127 / 393 112 / 274 centrifuge 400. EXAMPLE OF A MOVING CIRCUIT RETAINER

[0193] FIGS. 14A-14F illustrate a movable circuit retainer 1400 included in the apheresis system 200. As illustrated, the movable circuit retainer 1400 can be disposed at least partially within the centrifuge chamber 1402 of the apheresis system 200. The centrifuge chamber 1402 is defined as the internal space of the apheresis system 200 where the centrifuge assembly 400 is housed and, for example, located behind the access panel 224. As illustrated in FIG. 14B, the movable circuit retainer 1400 can be disposed above the centrifuge assembly 400 (for example, offset from the centrifuge assembly 400 in the positive z-axis direction). The 1400 movable circuit retainer may correspond to the 402 fixed circuit connection, or to a portion of the 402 fixed circuit connection, as described above.

[0194] The mobile circuit retainer 1400 may include a circuit support body (also called a circuit holder) 1408 having a circuit connection space (also called a circuit connection) 1412. A portion of the blood component collection assembly 500 may be held by the circuit connection space 1412. For example, as illustrated in FIG. 14C, the circuit connection space 1412 may be configured to receive or capture a portion of the flexible circuit 524, the system static circuit connector 528, or a combination thereof. In at least one embodiment, a connector locking wheel 1424 and a flange 1428 may function to lock (positively) the system static circuit connector 528 within the circuit connection space 1412.For example, as illustrated, the static circuit connector of system 528 and / or the flexible circuit 524 can be arranged between the upper locking wheel of connector 1424 and flange 1428, and the upper locking wheel of connector 1424 can be moved relative to flange 1428 to apply a pressure of. Petition 870250078665, dated 03 / 09 / 2025, page 128 / 393 113 / 274 retention to the static circuit connector of the system 528 and / or to the flexible circuit 524. In at least one embodiment, the movable circuit retainer 1400 may allow a shorter distance of the flexible circuit 524 to be used in the blood component collection set 500 than would be required in the absence of the movable circuit retainer 1400. In certain variations, the shorter distance may decrease the effective circulating volume of the blood component collection set 500. The shorter distance may reduce waste, for example, of materials used to make the blood component collection set 500, blood components remaining in the blood component collection set 500 after use, and the like. The shorter distance may provide a controlled length of the flexible circuit 524 so that the flexible circuit 544 resists entanglement, locking, and / or ensures proper loading in the apheresis system 200.

[0195] The movable circuit retainer 1400 can be movable (using an automated process or a manual process) between a first operational or extended state (see, for example, FIGS. 14A-14B and 14D) and a second loaded or restricted state (see, for example, 14E). For example, the movable circuit retainer 1400 may be movable (along the x-axis) from an extended position near a first or front side 202 of the apheresis system 200 to or toward a second or rear side 206 of the apheresis system 200. While in the extended position, the movable circuit retainer 1400 may be fixedly coupled to the blood component collection circuit 520. While in the retracted position, the blood component collection circuit 520 may be detached or disconnected from the circuit retainer body 1408. For example, the movable circuit retainer 1400 may include a release latch 1404 that may be actuated (e.g., pulled, unlocked, etc.).) unlocking the 1400 moving circuit retainer from a first. Petition 870250078665, dated 03 / 09 / 2025, p. 129 / 393 114 / 274 state or locked state to a second state or unlocked state. In the unlocked state, the circuit retainer body 1408 can be moved in a retraction direction 1420 (e.g., away from the front 202 and towards the rear 206 of the apheresis system 200 and / or housing 204). The retraction direction 1420 can be defined along the x-axis of the z-axis in the XZ plane.

[0196] In at least one embodiment, as illustrated for example in FIG. 14E, the retraction of the movable circuit retainer 1400 can provide clearance for the articulated upper housing 404B from an interior of the centrifuge chamber 1402 to a position outside the centrifuge chamber 1402 (compare, for example, FIGS. 4D and 4E and 4F). For example, when the circuit retainer body 1408 moves in the retraction direction 1420, the circuit retainer body 1408 can be positioned outside a filling opening articulation arc 1410, which is illustrated in FIG. 14C as an arched centerline rotating, for example, around the y-axis). A pivot clearance space 1416 may be provided between the circuit retainer body 1408 and the fill opening articulation arch 1410.The pivot clearance 1416 allows the upper housing 404B to rotate relative to the lower housing 404A as the split centrifuge housing 404 moves between an operating state and a loaded state and vice versa (e.g., without the upper housing 404B contacting the circuit retainer body 1408, etc.). For example, when the movable circuit retainer 1400 is in a retracted position, the upper housing 404B can fold and invert to allow the filling 460 to be loaded, for example, with a blood component collection circuit 520 and a blood component collection bladder 536. Once loaded, the upper housing 404B can be closed and secured in an operating state. When the upper housing 404B... Petition 870250078665, dated 03 / 09 / 2025, p. 130 / 393 115 / 274 is fixed in the operational state (for example, the upper housing 404B and the lower housing 404A are connected), the movable circuit retainer 1400 can be extended (for example, moved to the extended state) to retain the blood component collection circuit 520, for example, in a fixed position relative to the centrifuge assembly 400.

[0197] In at least one embodiment, when the movable circuit retainer 1400 is disposed in the extended state, the circuit retainer body 1408 can be displaced a first distance 1430A from the centrifuge assembly 400, including the upper housing 404B, preventing the upper housing 404B from moving between an operating state and a loading state and / or vice versa. For example, when the circuit retainer body 1408 is displaced the first distance 1430A in the extended state, the upper housing 404B would contact the circuit retainer body 1408 if the upper housing 404B were articulated relative to the lower housing 404A. To move the centrifuge assembly 400 between the operating state and the loading state, the movable circuit retainer 1400 needs first to be moved to the retracted state 1400B. When the movable circuit retainer 1400 is in the retracted state 1400B, for example, as illustrated in FIG.14C, the retracted circuit retainer body 1408' can be displaced a second distance 1430B from the centrifuge assembly 400. The second distance 1430B can be greater than the first distance 1430A and can define the pivot clearance space 1416 between the circuit retainer body 1408 and the filling opening articulation arc 1410. The filling opening articulation arc 1410 can correspond to a path associated with an outermost portion of the upper housing 404B, since the upper housing 404B articulates around the articulation axis of the split housing 406 (e.g., in relation to the lower housing 404A, etc.). While the movable circuit retainer 1400. Petition 870250078665, dated 03 / 09 / 2025, p. 131 / 393 116 / 274 is in the retracted state 1400B, the upper housing 404B can be articulated relative to the lower housing 404A without contacting the circuit retainer body 1408.

[0198] In at least one embodiment, when the moving circuit retainer 1400 is in the retracted state 1400B, the apheresis system 200 may not be able to operate. The apheresis system 200 can only operate when the moving circuit retainer 1400 is in the extended state. For example, the apheresis system 200 may include one or more sensors configured to detect a position of the moving circuit retainer 1400 and, based on the detected position, provide an input including information about the position of the moving circuit retainer 1400 to the apheresis system 200 controller. In response, the controller may restrict the operation of the apheresis system 200 when the moving circuit retainer 1400 is in the retracted state, while allowing the operation of the apheresis system 200 when the moving circuit retainer 1400 is in the extended state.

[0199] The apheresis system 200 can be loaded with a portion of a blood component collection set 500 by moving the movable circuit retainer 1400 to the retracted state 1400B and articulating the upper housing 404B to the loading position (see, for example, FIGS. 4F and 6A). In at least one embodiment, when the upper housing 404B is open and in the loading state, at least a portion of the upper housing 404B can extend out of the centrifuge chamber 1402. In this inverted loading state, the inverted upper housing 404B can provide clearance and accessibility for loading the blood component collection bladder 536 into the filling 460 (for example, disposed in the upper housing 404B), as described above. When the blood component collection circuit 520 is connected, or otherwise coupled, to the filling 460, the upper housing 404B may Petition 870250078665, dated 03 / 09 / 2025, p. 132 / 393 117 / 274 can be articulated from the loaded state to the operational state (see, for example, FIGS. 6C). In this position, the movable circuit retainer 1400 can be moved from the retracted state 1400B to the extended state (see, for example, FIG. 14C) and the static circuit connector of the system 528 of the blood component collection circuit 520 can be interconnected with the circuit connection space 1412 of the circuit retainer body 1408. Unloading the filler 460 can be performed by reversing the order of operations described above. For example, unloading the filler 460 and / or the centrifuge assembly 400 may include disconnecting the static circuit connector of the system 528 from the circuit connection space 1412 and moving the circuit support 1400 from the extended state to the retracted state 1400B. Once in the retracted state 1400B, the upper housing 404B can be rotated or articulated from the operating position to the open loading position.In the open position, the blood component collection circuit 520 can be disconnected and removed from the filler 460. The loading and unloading process can be repeated to reload the filler 460 and / or the centrifuge assembly 400 between uses or operations of the apheresis system 200.

[0200] In at least one embodiment, the present disclosure provides an apheresis system. The apheresis system may include a housing with a front and a rear side, a centrifuge chamber disposed in the housing, a centrifuge assembly disposed in the centrifuge chamber, and a movable circuit retainer disposed in the centrifuge chamber, wherein the movable circuit retainer includes a circuit support body and a circuit connection space disposed in the circuit support body. The circuit connection space may be sized to receive a connector for a flexible circuit. The movable circuit retainer may be movable between an extended state within the centrifuge chamber and a retracted state. Petition 870250078665, dated 03 / 09 / 2025, p. 133 / 393 118 / 274 inside the centrifuge chamber, where in the extended state, the circuit retainer body is disposed offset a first distance from the centrifuge assembly, and in the retracted state, the circuit retainer body is disposed offset a second distance from the centrifuge assembly, and the second distance is greater than the first distance. In at least one embodiment, the centrifuge assembly may include a centrifuge housing, and the centrifuge housing may include a loaded state and an operational state. The centrifuge housing may be prevented from moving from the operational state to the loaded state when the movable circuit retainer is in the extended state, and the centrifuge housing may be allowed to move from the operational state to the loaded state when the movable circuit retainer is in the retracted state.In at least one embodiment, the centrifuge housing may include a split housing comprising a lower housing portion and an upper housing portion, wherein the upper housing portion articulates with respect to the lower housing portion, and the upper housing portion articulates along an arc when moving between the operating state and the load state. In at least one embodiment, when the movable circuit retainer is in the retracted state, a clearance space may be provided between the circuit retainer body and the arc to provide a path of movement along the arc for the upper housing portion to articulate with respect to the lower housing portion between the operating state and the load state, free from the circuit retainer body.In at least one embodiment, when the movable circuit retainer is in the extended state, the clearance can be removed between the circuit retainer body and the arc can prevent the upper portion of the housing from articulating relative to the lower portion of the housing between the operating state and the loading state. In at least... Petition 870250078665, dated 03 / 09 / 2025, p. 134 / 393 119 / 274 except for one embodiment, when the movable circuit retainer is in the retracted state, the circuit retainer body may be disposed closer to the rear of the housing than when the movable circuit retainer is in the extended state. In at least one embodiment, the circuit retainer body may include a connector latch that engages with the connector of a flexible circuit, locking the flexible circuit relative to the circuit retainer body and the circuit connection space. In at least one embodiment, the movable circuit retainer may include a circuit support body and a circuit connection space disposed within the circuit support body. The circuit connection space may be sized to accommodate a connector from a flexible circuit of a blood component collection assembly.The movable circuit retainer may be movable between an extended state within a centrifuge chamber of an apheresis system and a retracted state within the centrifuge chamber, wherein in the extended state, the circuit support body is disposed offset by a first distance from a centrifuge assembly disposed in the centrifuge chamber, and in the retracted state, the circuit support body is disposed offset by a second distance from the centrifuge assembly disposed in the centrifuge chamber. The second distance may be greater than the first. In at least one embodiment, the circuit retainer body may include a connector latch that engages with the connector of a flexible circuit so as to lock the flexible circuit relative to the circuit retainer body and the circuit connection space.

[0201] In at least one embodiment, a method is provided for loading a centrifuge packing of an apheresis system. The method may include providing an apheresis system comprising a housing with front and rear sides, a centrifuge chamber disposed in the housing, Petition 870250078665, dated 03 / 09 / 2025, p. 135 / 393 120 / 274 a centrifuge assembly disposed in the centrifuge chamber and a movable circuit retainer disposed in the centrifuge chamber. The centrifuge assembly may have a split housing comprising a lower housing portion and an upper housing portion, wherein the upper housing portion articulates with respect to the lower housing portion. The centrifuge housing may have a loaded state and an operational state. The movable circuit retainer may include a circuit support body and a circuit connection space disposed in the circuit support body. The circuit connection space may be dimensioned to receive a flexible circuit connector.The movable circuit retainer can be moved between an extended state within the centrifuge chamber and a retracted state within the centrifuge chamber, where in the extended state, the circuit retainer body can be disposed offset a first distance from the centrifuge assembly, and in the retracted state, the circuit retainer body is disposed offset a second distance from the centrifuge assembly. The second distance can be greater than the first. The upper portion of the housing can articulate along an arc when moving between the operating state and the loading state, where the split housing can be prevented from moving from the operating state to the loading state when the movable circuit retainer is in the extended state, and the split housing can be allowed to move from the operating state to the loading state when the movable circuit retainer is in the extended state.The method for loading a centrifuge packing may further include activating a release latch to unlock the moving circuit retainer from a locked to an unlocked state; moving the moving circuit retainer from the extended to the retracted state; articulating, while the moving circuit retainer is in the retracted state, the upper portion of the housing relative to the lower portion. Petition 870250078665, dated 03 / 09 / 2025, p. 136 / 393 121 / 274 lower housing so that the upper portion of the housing is at least partially disposed outside the centrifuge chamber and the upper portion of the housing is in the loading state; attach a blood component collection bladder and a flexible circuit from a blood component collection set with a filler disposed in the upper portion of the housing while the upper portion of the housing is in the loading state; articulate, while the movable circuit retainer is in the retracted state, the upper portion of the housing relative to the lower portion of the housing so that the upper portion of the housing is disposed inside the centrifuge chamber and the upper portion of the housing is in the operational state; and move the movable circuit retainer from the retracted state to the extended state, causing the release latch to lock the movable circuit retainer in the locked state. EXAMPLE OF A BOTTLE TRAY WITH MAGNETIC COUPLING AND LOAD CELL OVERLOAD PROTECTION

[0202] FIGS. 15A-15M show various views of a load cell assembly and its components according to at least one embodiment. FIG. 15A is a perspective view of the load cell assembly according to at least one embodiment. FIG. 15B is an exploded perspective view of the load cell assembly of FIG. 15A according to at least one embodiment.

[0203] At least in the embodiment shown, the load cell assembly 1500 is a bottle tray load cell assembly. The load cell assembly 1500 includes a fixed portion, a deflection portion (FIG. 15B), and a load cell 1506. In at least one embodiment, the fixed portion includes a plate 1508 (also referred to as a “mounting plate”) and a support 1510 (also referred to as a “load cell support”). In at least one embodiment, the Petition 870250078665, dated 03 / 09 / 2025, p. 137 / 393 The 122 / 274 deflection portion includes a first component 1512 (also referred to as the “load interface plate”), a second component 1514 (also referred to as the “overload support bar”), and a cradle 1516 (also referred to as the “bottle cradle” or “plasma collection cradle”). The load cell assembly 1500 may extend along a central or longitudinal axis 1517. In at least one embodiment, the longitudinal axis 1517 passes through the center of the load cell 1506.

[0204] In at least one embodiment, the cradle 1516 may be similar to the plasma collection cradle 232C of FIG. 2A. The plasma collection cradle 1516 may be attached to the overload support bar 1514. As described above, the plasma collection cradle 1516 may be configured to receive, orient, and / or retain a vessel, such as a plasma collection bottle (e.g., bottle 1598 of FIG. 15M or vessel 2716 of FIG. 26J), in an apheresis system, such as the apheresis system 200 shown in (FIG. 1A). In at least one embodiment, the load cell 1506 is configured to deflect and detect a load and / or weight from a vessel. The load cell 1506 may be sensitive to forces within a predetermined (or alternatively, desired) range. For example, when the forces applied to load cell 1506 are below the predetermined range (e.g., above), the accuracy of the load measurements and / or the integrity of load cell 1506 may be compromised.

[0205] In at least one embodiment, the cradle 1516 is coupled to the load cell 1506 by means of a magnetic coupling and interface. The magnetic coupling can be configured to mechanically separate the cradle 1516 from the load cell 1506, reducing or preventing mechanical forces from continuing to be applied to the bending beams and / or the load cell 1506. In at least one embodiment, as will be described in greater detail below, upon reaching a predetermined load amount, the cradle 1516 can break a force of Petition 870250078665, dated 03 / 09 / 2025, page 138 / 393 123 / 274 magnetic interconnection separating cradle 1516, plate 1508 and the second component 1514 of the apheresis system 200. Among other things, this magnetic interconnection can reduce or prevent damage to load cell 1506, sensing components, support elements, bending beams and / or other mechanical elements located between cradle 1516 and load cell 1506.

[0206] In at least one embodiment, the first component 1512 includes a first magnet 1518 and the second component 1514 includes a second magnet 1520. The first magnet 1518 can be coupled to the first component 1512 by a first fastener 1522A. The second magnet 1520 can be coupled to the second component 1514 by a second fastener 1522B. As will be described in more detail below, the load cell 1506 can be coupled to the support 1510 by one or more third fasteners 1522C. The first component 1512 can be coupled to the load cell 1506 by one or more fourth fasteners 1522D. The mounting plate 1508 can be coupled to the support 1510 by one or more fifth fasteners 1522E. The second component 1514 can be attached to the cradle 1516 by one or more sixth fasteners 1522F.In at least one embodiment, fasteners 1522A, 1522B, 1522C, 1522D, 1522E, 1522F can be independently selected from flat head screws, hexagonal head screws, hex head bolts, nuts and / or the like.

[0207] FIG. 15C is a top perspective view of a mounting plate of the load cell assembly of FIG. 15A according to at least one example embodiment. FIG. 15D is a bottom perspective view of the mounting plate of FIG. 15C according to at least one example embodiment.

[0208] In at least one embodiment, as shown in FIGS. 15C-15D, the mounting plate 1508 includes a substantially flat body 1524 having a first side 1526A and a second side 1526B. The flat body 1524 may define Petition 870250078665, dated 03 / 09 / 2025, p. 139 / 393 124 / 274 a substantially rectangular perimeter (for example, a rectangle with rounded corners).

[0209] In at least one embodiment, the flat body 1524 defines one or more first openings 1528 (e.g., four openings 1528, as shown). Fasteners (not shown) may extend through the first openings 1528 to couple the load cell assembly 1500 (shown in FIGS. 15A-15B) to the apheresis system 200 (shown in FIG. 1A) via the mounting plate 1508. In at least one embodiment, the load cell assembly of the flask tray 1500 may be completely removed from the apheresis system 200 by removing the fasteners. Among other things, this feature allows for the quick replacement and / or maintenance of the 1500 bottle tray load cell assembly and / or any component of the 1500 bottle tray load cell assembly, as will be described in more detail below in the discussion accompanying FIG. 18A.

[0210] In at least one embodiment, a first flange 1530 extends from the flat body 1524 on the first side 1526A. The first flange 1530 may define a rectangular shape. In at least one embodiment, the mounting plate 1508 includes a gasket 1532 (shown in FIG. 15D) on the first side 1526A. The gasket 1532 may be adjacent to the first flange 1530. When the load cell assembly 1500 (shown in FIGS. 15A-15B) is coupled to the apheresis system 200 (shown in FIG. 1A), the gasket 1532 is between the flat body 1524 of the plate 1508 and the housing 204 (shown in FIG. 2A). In at least one embodiment, gasket 1532 may be or include a sealing ring, a flat sealing gasket, or other compatible sealing element. Additionally or alternatively, gasket 1532 may be or include an electromagnetic interference (EMI) shielding gasket (e.g., metallic gasket, spring, metallized gasket, and / or the like). Petition 870250078665, dated 03 / 09 / 2025, p. 140 / 393 125 / 274

[0211] In at least one embodiment, the flat body 1524 defines a second opening 1534. The second opening 1534 may be a central opening. In at least one embodiment, a second flange 1536 may extend from the second side 1526B of the flat body 1524. The second flange 1536 may be a circular flange. The second flange 1536 may extend around the second opening 1534. In at least one embodiment, a portion of the second component 1514 (shown in FIGS. 15A-15B) extends through the second opening 1534. The second component 1514 may be configured to translate along the longitudinal axis 1517 as the deflection portion (shown in FIGS. 15A-15B) of the load cell assembly 1500 deflects.In at least one embodiment, an amount of deflection may be very small, such as less than or equal to about 0.05 inches (0.127 centimeters) (for example, less than or equal to about 0.01 inches (0.0254 centimeters), or less than or equal to about 0.005 inches (0.0127 centimeters)).

[0212] FIG. 15E is a perspective view of a load cell assembly support of FIG. 15A according to at least one exemplary embodiment.

[0213] In at least one embodiment, as shown in FIG. 15E, the support 1510 includes a wall 1538 and a third flange 1540. The third flange 1540 may include a first flange portion 1540A and a second flange portion 1540B. The first and second flange portions 1540A, 1540B may be spaced apart from each other. The first and second flange portions 1540A, 1540B may include respective top surfaces 1541A, 1541B. The top surfaces 1541A, 1541B may be coplanar.

[0214] In at least one embodiment, wall 1538 defines a receptacle 1542. The receptacle 1542 may define a substantially rectangular shape. The receptacle 1542 may Petition 870250078665, dated 03 / 09 / 2025, page 141 / 393 126 / 274 receive at least a portion of the load interface plate 1512 and / or at least a portion of the overload support bar 1514, as shown in FIG. 15I.

[0215] Wall 1538 may further define a depression 1543. The depression 1543 may define a semicylindrical shape. The depression 1543 may extend between the receptacle 1542 and an upper surface 1544 of wall 1538. The depression may receive at least a portion of the overload support bar 1514, as shown in FIG. 15I.

[0216] In at least one embodiment, the support 1510 may further include reinforcements 1546 extending between the wall 1538 and the third flange 1540. In at least one embodiment, the wall 1538, the third flange 1540, and the reinforcements 1546 may cooperate to define an internal support region 1547. As will be described in more detail below, in at least one embodiment, the load cell 1506, the first component 1512, and a portion of the second component 1514 may be in the region of the internal support 1547. Consequently, when the mounting plate 1508 is fixed to the housing 204 of the apheresis system 200 (shown in FIG. 2A), the support 1510 may be within a protected portion of the apheresis system 200 (e.g., protecting the load cell 1506). and / or other components of the load cell assembly 1500 against damage, tampering and / or an environment outside the apheresis system 200, etc.).

[0217] In at least one embodiment, the support 1510 is fixed to the mounting plate 1508. In the embodiment shown, the support 1510 is fixed to the first side 1526A of the mounting plate 1508. The upper surface 1544 of the wall 1538 of the support 1510 may define one or more third openings 1550. The fifth fasteners 1522E may extend through the third openings 1550 and the plate 1508 to couple the support 1510 to the mounting plate 1508. The second flange portion 1540B Petition 870250078665, dated 03 / 09 / 2025, page 142 / 393 127 / 274 can define one or more fourth openings 1551. At least in the example embodiment shown, the third fasteners 1522C can extend through the fourth openings 1551 to couple the load cell 1506 (shown in FIGS. 15A-15B) to the support 1510, as will be described in more detail below.

[0218] FIG. 15F is a perspective view of a load cell from the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0219] In at least one embodiment, as shown in FIG. 15F, the load cell 1506 includes a fixed end 1552 (or fixed side) and a free end 1554 (or free side or load deflection side). As shown in FIG. 15A, the fixed end 1552 is fixed to the support 1510. Specifically, the fixed end 1552 of the load cell 1506 may be in contact with the second flange portion 1540B. In at least one embodiment, the fixed end 1552 of the load cell 1506 may be in direct contact with the second flange portion 1540B. The load cell 1506 may be at least partially within the region of the inner support 1547 of the support 1510.

[0220] In at least one embodiment, the free end 1554 of the load cell 1506 is spaced from at least a portion of the support 1510, such as the first flange portion 1540A, to define a deflection region 1556 (also shown in FIGS. 15A and 15I). The free end 1554 of the load cell 1506 is configured to move within the deflection region 1556 in response to the application of a force or load in a first direction 1558. The first direction 1558 may be substantially parallel to the central axis 1517.

[0221] In at least one embodiment, load cell 1506 is a bending-based load cell. As the free end 1554 moves or translates relative to the fixed end 1552, load cell 1506 can determine Petition 870250078665, dated 03 / 09 / 2025, page 143 / 393 128 / 274 a force, weight, or load associated with the measured deflection. Although load cell 1506 may be able to receive forces perpendicular to a bending element of load cell 1506 (e.g., in the first direction 1558), load cell 1506 may be sensitive to received rotational, torsional, or parallel forces. Examples of load cell 1506 include, but are not limited to, a shear beam load cell, an S-beam load cell, a single-point load cell, a double shear beam load cell, a bending beam load cell, a canister load cell, an extensometer, a bending load cell, and / or combinations thereof.

[0222] Returning to FIGS. 15A-15B, in at least one embodiment, the load cell assembly 1500 includes a magnetic coupling between the load interface plate 1512 and the overload support bar 1514. At least in the embodiment shown, the load interface plate 1512 includes the first magnet 1518 and the overload support bar 1514 includes the second magnet 1520. The magnets 1518, 1520 can be arranged so that opposite poles face each other when the overload support bar 1514 is engaged with the load interface plate 1512, as shown in FIG. 15I. This arrangement causes a magnetic force between the magnets 1518, 1520 to maintain the overload support bar 1514 in an engaged state with the load interface plate 1512.

[0223] FIG. 15G is a perspective view of a load interface plate of the load support assembly of FIG. 15A according to at least one exemplary embodiment.

[0224] In at least one embodiment, as shown in FIG. 15G, the load interface board 1512 includes an interface body or first cam body 1560 and an extension or mounting 1562. The load interface board 1512 may define a first side load cell 1564A and a Petition 870250078665, dated 03 / 09 / 2025, page 144 / 393 129 / 274 second side of interface 1564B. The first cam body 1560 can define a first recess or depression 1566. The load interface shaft 1517A can be aligned with the central shaft 1517 (shown in FIG. 15A) when the load cell assembly 1500 (shown in FIG. 15A) is mounted. The first magnet 1518 may be at least partially in the first recess 1566. A load interface shaft 1517A may extend through a center of the first recess 1566. The first magnet 1518 (shown in FIG. 15B) may be glued, pinned, crimped, or otherwise fixed within the first recess 1566. At least in the example embodiment shown, the first magnet 1518 may be fixed to the overload support bar 1514 by means of the first fastener 1522A, such as a flat-head screw.In at least one embodiment, a surface of the first magnet 1518 may be arranged flush with, or below, a first cam surface 1567 of the overhead support bar 1514.

[0225] In at least one embodiment, the first cam surface 1567 defines a plurality of valleys 1568. At least in the embodiment shown, the plurality of valleys 1568 includes a first valley 1568A, a second valley 1568B, and a third valley 1568C. The valleys 1568 may be arranged asymmetrically around the load interface axis 1517A (for example, having centers arranged approximately 90° apart from each other). In at least one embodiment, each of the valleys 1568 may be configured as a cavity or recess having at least one inclined, chamfered, or tapered side.

[0226] In at least one embodiment, the first cam surface 1677 may further define a first planar portion 1569. In the embodiment shown, the first planar portion 1569 lies between the first valley 1568A and the third valley 1568C. The first planar portion 1569 may extend uninterruptedly between the first valley 1568A and the third valley Petition 870250078665, dated 03 / 09 / 2025, page 145 / 393 130 / 274 1568C. The valleys 1568A, 1568B, 1568C and the first flat portion 1569 may be circumferentially around the first recess 1566.

[0227] In at least one embodiment, the second side 1564B of the first cam body 1560 may further define a plurality of notches 1570. Each of the notches in the plurality 1570 may correspond to one of the valleys 1568. The notches 1570 may be centered within each of the respective valleys 1568.

[0228] Extension 1562 may be adjacent to the first cam body 1560. At least in the embodiment shown, extension 1562 defines a substantially rectangular cross-section. Extension 1562 may define one or more fourth openings 1571. The fourth openings 1571 may receive fourth fasteners 1522D to couple the load interface plate 1512 to the load cell 1506 (shown in FIG. 15B).

[0229] FIG. 15H is a perspective view of an overload support bar of the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0230] With reference to FIG. 15H, in at least one exemplary embodiment, the overload support bar 1514 includes a mandrel 1572 extending for a length along a longitudinal axis or support bar 1517B (for example, coinciding with axis 1517 of FIG. 15A) from a first end 1573A to a second end 1573B. In at least one exemplary embodiment, the overload support bar 1514 includes a second cam body 1574 at the first end 1573A and a coupling portion 1775 at the first end 1573A.

[0231] In at least one embodiment, the coupling portion 1575 has a larger diameter than the mandrel 1572. The coupling portion 1575 may define a receptacle, such as a fifth opening 1575A. The fifth opening 1575A may cooperate with Petition 870250078665, dated 03 / 09 / 2025, p. 146 / 393 131 / 274 the sixth fastener 1522F for attaching the cradle 1516 (shown in FIG. 15A) to the overload support bar 1514.

[0232] In at least one embodiment, the second cam body 1574 is substantially cylindrical. The second cam body 1574 may define a second recess or depression 1576. The axis of the support bar 1517B may extend through a center of the second recess 1576. The axis of the support bar 1517B may be aligned with the center axis 1517 when the load cell assembly 1500 (shown in FIG. 15A) is mounted. The second magnet 1520 may be at least partially in the second recess 1576. The second magnet 1520 (shown in FIG. 15B) may be glued, pinned, riveted or otherwise fixed within the second recess 1576. At least in the example embodiment shown, the second magnet 1520 may be fixed to the overload support bar 1514 by means of the second fastener 1522B, such as a flat-head screw.In at least one embodiment, a surface of the second magnet 1520 may be arranged flush with, or below, a second cam surface 1577 of the overhead support bar 1514.

[0233] In at least one embodiment, the second cam surface 1577 defines a plurality of lobes 1578. At least in the example embodiment shown, the plurality of lobes 1578 includes a first lobe 1578A, a second lobe 1578B, and a third lobe 1578C. The lobes 1578 may be arranged asymmetrically around the axis of the support bar 1517B (for example, having centers arranged approximately 90° apart from each other). In at least one embodiment, each of the lobes 1578 may be configured as a protrusion having at least one inclined, or conical, side extending from one end of the protrusion.

[0234] In at least one embodiment, the second cam surface 1577 of the second cam body 1574 may further define a second planar portion 1579. In the example of Petition 870250078665, dated 03 / 09 / 2025, page 147 / 393 132 / 274 embodiment shown, the second flat portion 1579 is between the first lobe 1578A and the third lobe 1578C. The second flat portion 1579 may extend uninterruptedly between the first lobe 1578A and the third lobe 1578C. The lobes 1578 and the second flat portion 1579 may be circumferentially around the second recess 1576.

[0235] In at least one embodiment, a benefit of the asymmetric arrangement of lobes 1578 and valleys 1568 (shown in FIG. 15G) is that the overload support bar 1514 can engage with the load interface plate 1512 in only one orientation (e.g., avoiding improper mounting of the plasma collection cradle 1516 in the apheresis system 200, etc.). In at least one embodiment, among other things, this asymmetric arrangement can ensure that the plasma collection cradle 1516 is always mounted substantially in the same orientation as the apheresis system 200.

[0236] In at least one embodiment, with reference to FIGS. 15G-15H, the arrangement of the 1568 valleys (FIG. 15G) can provide at least one coupling surface at each location of the 1568 valleys that is configured to contact a corresponding surface of the 1578 lobes (FIG. 15H). When the overload support bar 1514 is engaged with the load interface plate 1512 (e.g., in an engaged state), the first cam lobe 1578A can align and be within the first 1568A valley, the second lobe 1578B can align and be within the second 1568B valley, and the third lobe 1578C can align and be within the third 1578C valley. In at least one embodiment, the first cam surface 1567 may be in continuous and uninterrupted contact with the second cam surface 1577.

[0237] In at least one embodiment, when the overload support bar 1514 is forced to tilt, twist or rotate relative to the load interface plate 1512 (by Petition 870250078665, dated 03 / 09 / 2025, page 148 / 393 133 / 274 example, by means of an external force applied to the plasma collection cradle 1516, shown in FIG. 15A, and / or a plasma collection bottle in the plasma collection cradle 1516, etc.), at least a portion of the second cam surface 1577 can be disengaged from (e.g., without direct contact) the first cam surface 1567. At least in this example embodiment, as the overload support bar 1514 rotates about the axis 1517B, one or more of the various lobes 1578 can be forced to contact the first flat portion 1569 of the load interface plate 1512.

[0238] FIG. 15I is a partial sectional view of the load cell assembly of FIG. 15A in an engaged state according to at least one exemplary embodiment. FIG. 15J is a partial sectional view of the load cell assembly of FIG. 15A in a disengaged state, with a portion of a first magnet cut off, according to at least one exemplary embodiment.

[0239] In at least one embodiment, as shown in FIGS. 15I-15J, each of the magnets 1518, 1520 has a first pole side 1580A (e.g., a north pole) and a second pole side 1580BB (e.g., a south pole). The first pole side 1580A has a first polarity and the second pole side 1580B has a second polarity that is opposite to the first polarity. The magnets 1518, 1520 are arranged respectively so that the opposite poles (i.e., poles with opposite polarity) are facing each other. In the example embodiment shown, the first magnet 1518 is in the first recess 1566 of the load interface plate 1512, so that the first pole side 1580A of the first magnet 1518 is facing the overload support bar 1514. The second magnet 1520 is in the second recess 1576 of the overload support bar 1514, so that the second pole side 1580B of the second magnet 1520 is facing the load interface plate 1512.In at least one other example of a modality, a set of load cells can... Petition 870250078665, dated 03 / 09 / 2025, page 149 / 393 134 / 274 include a single magnet arranged on one load interface plate or overload support bar with a magnetically attractive metal (e.g., iron, steel, etc.) arranged on the other load interface plate or overload support bar.

[0240] The load cell assembly of the flask tray 1500 may be able to provide overload protection for the load cell 1506 and / or other components by the overload support bar 1514 moving between the engaged state shown in FIG. 15I to the disengaged state shown in FIG. 15J when a predetermined motion and / or force is received by the overload support bar 1514. The motion and / or force may correspond to a rotation about the central axis 1517 in the direction of rotation 1582, a moment about the axis 1517, a moment about the y-axis shown, a moment about the x-axis shown and / or combinations thereof. Among other things, the ability to disengage the overload support bar 1514 from the load interface plate 1512 avoids non-linear forces (e.g., forces that do not act only along the z-axis, providing a weight vector, etc.).) damage the load cell 1506 and / or the components of the load cell assembly of the bottle tray 1500.

[0241] In at least one embodiment, as shown in FIG. 15J, a force is received in the first direction of rotation 1582A, causing the overload support bar 1514 to rotate counterclockwise relative to the load interface plate 1512. This force may be caused by an accidental impact and / or twisting of the cradle 1516, causing the overload support bar 1514 to rotate about the axis 1517. As the overload support bar 1514 rotates, the lobes 1578 may move along the inclined or tapered sides of the valleys 1568, raising the overload support bar 1514 relative to the load interface plate 1512 and causing the overload support bar 1514 to separate by at least Petition 870250078665, dated 03 / 09 / 2025, page 150 / 393 135 / 274 partially from the load interface plate 1512. In at least one embodiment, in a fully disengaged state, the overload support bar 1514 is separated from the load interface plate 1512 by a separation offset distance 1583. In this position, the lobes 1578 may be in contact with the first flat portion 1569 of the load interface plate 1512 and removed or disengaged from the valleys 1568.

[0242] When the overload support bar 1514 separates from the load interface plate 1512, a separation gap 1584 can be defined between the overload support bar 1514 and the load interface plate 1512. This separation gap 1584 can cause a sufficient gap between the first and second magnets 1518, 1520 so that the continuous rotational forces applied to the overload support bar 1514 do not exert a specific force (e.g., torsion, rotation and / or moment, etc.) on the load interface plate 1512. In at least one embodiment, the magnetic force between the magnets 1518, 1520 when in the disengaged state (e.g., due in part to the separation displacement distance 1583) is less than the magnetic force between the magnets 1518, 1520 when in the engaged state (shown in FIG. 15I). Consequently, the 1506 load cell is protected from any continuous rotational or moment forces.To reset the load cell assembly of the flask tray 1500, the overload support bar 1514 can be rotated until the lobes 1578 align with the valleys 1568, the overload support bar 1514 moves towards the load interface plate 1512, and the separation offset distance 1583 is reduced and / or closed.

[0243] FIG. 15K is a side elevation view of a cradle of the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0244] In at least one embodiment example, as shown in FIG. 15K, the cradle 1516 includes a wall 1586 that Petition 870250078665, dated 03 / 09 / 2025, page 151 / 393 136 / 274 defines at least partially a region of the vessel 1587. The wall 1586 may be partially cylindrical. A lid 1588 may be attached to the wall 1586 to facilitate the alignment and / or retention of a vessel within the region of the vessel 1587. In at least one embodiment, the lid 1588 facilitates the proper removal of a vessel (see, for example, vessel 1598 of FIG. 15M) from the cradle 1516 by lifting one end of the port or the top of a vessel before the bottom of the vessel, reducing or preventing leakage of the vessel contents from a vessel vent port.

[0245] Wall 1586 may extend between a first end 1586A and a second end 1586B. In at least one embodiment, the second end 1586B of wall 1586 includes a pair of alignment surfaces 1589. An alignment angle 1590 may be defined between the alignment surfaces 1589. In at least one embodiment, the alignment angle 1590 is greater than or equal to about 90° (for example, greater than or equal to about 100°, greater than or equal to about 110°, greater than or equal to about 120°, greater than or equal to about 130°, greater than or equal to about 140°, or greater than or equal to about 150°). The alignment angle of 1590° can be less than or equal to approximately 160° (for example, less than or equal to approximately 150°, less than or equal to approximately 140°, less than or equal to approximately 130°, less than or equal to approximately 120°, less than or equal to approximately 110°, or less than or equal to approximately 100°).Alignment surfaces 1589 can cooperate to define at least partially an alignment region 1591. In at least one embodiment, the wall 1586 further defines a groove 1592 between alignment surfaces 1589. Alignment surfaces 1589 and / or the groove 1592 can, in at least one embodiment, facilitate the proper alignment of a vessel within the cradle 1516, as will be described in greater detail below. Petition 870250078665, dated 03 / 09 / 2025, page 152 / 393 137 / 274

[0246] In at least one embodiment, the wall 1586 defines one or more receptacles 1586C. The receptacles 1586C can be configured to receive at least a portion of a calibration weight. At least in the embodiment shown, the receptacles 1586C are dimensioned and shaped to receive a lower portion of a cylindrical calibration weight. When the cylindrical calibration weight is at least partially within the receptacles 1586C, a longitudinal axis of the cylindrical calibration weight is substantially parallel to the central axis 1517 (shown in FIG. 15A) of the load cell assembly 1500 (shown in FIG. 15A).

[0247] FIG. 15L is a front elevation view of the cradle of FIG. 15K according to at least one embodiment example.

[0248] In at least one embodiment, as shown in FIG. 15L, the cradle 1516 can be configured to retain a vessel in a desired orientation. The cradle 1516 can define a vessel angle 1594 between the bottom of the wall 1586 and a horizontal plane 1595 (i.e., a plane that is perpendicular to the direction of gravity). In at least one embodiment, the angle can be greater than about 0° (e.g., greater than or equal to about 1°, greater than or equal to about 2°, greater than or equal to about 3°, greater than or equal to about 5°, or greater than or equal to about 10°). The angle of vase 1594 may be less than or equal to approximately 45° (for example, less than or equal to approximately 40°, less than or equal to approximately 35°, less than or equal to approximately 30°, less than or equal to approximately 25°, less than or equal to approximately 20°, less than or equal to approximately 15°, less than or equal to approximately 10°, less than or equal to approximately 8°, or less than or equal to approximately 5°).

[0249] FIG. 15M is a perspective view of a vase in the cradle of FIG. 15K according to at least one embodiment.

[0250] In at least one example of a modality, as Petition 870250078665, dated 03 / 09 / 2025, page 153 / 393 138 / 274 shown in FIG. 15M, the cradle 1516 is configured to retain a vessel in a desired orientation. At least in the embodiment shown, the vessel is a flask 1598. The flask 1598 may be similar to or the same as the flask 1900 of FIG. 19A. The flask 1598 may include a cap 1598A. The cap 1598A may include a protrusion 1598B including a pair of vessel alignment surfaces 1598C, a pair of side surfaces 1598D and an opposite surface 1598E. The cap 1598A may further include a fluid port 1598F and a vent port 1598G. In at least one embodiment, when bottle 1598 is installed in cradle 1516 for use, a vent cap 1598H can be removed from vent port 1598G and a tube and connector can be attached to fluid port 1598F (see, for example, FIGS. 19I, 19J).

[0251] In at least one embodiment, when the flask 1598 is correctly oriented in the cradle 1516, the protrusion 1598B is at least partially within the alignment region 1591. The alignment surfaces 1589 of the cradle 1516 engage (i.e., are in direct contact with) the alignment surfaces of the flask 1598C, and the fluid port 1598F is at least partially within the groove 1592. Consequently, the vent port 1598G is oriented at a higher location than the fluid port 1598F, at a location above a predetermined (or alternatively, desired) fluid level. In this orientation, the filling capacity of the flask 1598 can be increased or maximized compared to other orientations, since the positioning of the vent port 1598G at the top allows for a greater filling volume without the contents overflowing through the vent port 1598G.Furthermore, this orientation can reduce or minimize the residual volume so that fluid can be withdrawn from vessel 1598 without aspirating air. Vessel 1598 is oriented at the angle of vessel 1594. The angle of vessel 1594 can be selected for... Petition 870250078665, dated 03 / 09 / 2025, page 154 / 393 139 / 274 balance residual needs with high filling volume.

[0252] In at least one embodiment, as will be discussed in greater detail below in the discussion accompanying FIG. 26J, the flask 1598 and / or the cap 1598A can be dimensioned and shaped to ensure proper positioning of the cap 1598A of the flask 1598 below the bottom of the flask 1598 in the cradle 1516. That is, the cap 1598A can be oriented towards the first wall end 1586A and the bottom of the flask 1598 can be oriented towards the second wall end 1586B.

[0253] In at least one embodiment, bottle 1598 and cradle 1516 include one or more features to facilitate visual identification of improper loading. A user can easily identify when bottle 1598 is positioned at a different angle than the angle of vessel 1594 (FIG. 15K), i.e., when a longitudinal axis of bottle 1598 is not parallel to cradle 1516. Additionally or alternatively, a user can easily identify when the alignment surfaces of vessel 1598C are not fully seated on the alignment surfaces 1589 of cradle 1516. Additionally or alternatively, a user can identify when ports 1598F, 1598G are not vertically aligned, with fluid port 1598F within groove 1592G. Additionally or alternatively, a user can identify when a 1598I label on bottle 1598 is not visible, facing upwards, and / or substantially centered within cradle 1516.

[0254] In contrast, in at least one embodiment, when the flask 1598 is in an improper orientation within the cradle 1516, the opposite surface engages one or both of the alignment surfaces 1589, thus preventing the protrusion 1598B from being in the alignment region 1591. In the improper orientation, fluid can be pushed from the flask 1598 through Petition 870250078665, dated 03 / 09 / 2025, page 155 / 393 140 / 274 of the 1598G vent port, which may be below the fluid level in the incorrect orientation. When the flow is reversed, air is drawn from bottle 1598 instead of the intended fluid.

[0255] Exemplary aspects are directed to a flask tray load cell assembly comprising: a support; a load cell comprising a fixed side and a load deflection side offset from the fixed side, wherein the fixed side of the load cell is fixed to the support; an interface plate fixed to the load deflection side of the load cell, the interface plate comprising: a body; a first magnetic recess disposed in the body; and a plurality of cam lobe valleys at least partially around the first magnetic recess, wherein the plurality of cam lobe valleys interrupts a first contact surface of the body; a support bar comprising: a mandrel extending for a length along a longitudinal axis from a first end of the mandrel to a second end of the mandrel; a cam body disposed in the second end of the mandrel; a second magnetic recess disposed in the cam body;and a plurality of cam lobes extending from the cam body, the plurality of cam lobes arranged at least partially around the second magnetic recess; wherein the support bar is movable between an engaged state with the interface plate and a disengaged state from the interface plate, wherein, in the engaged state, the plurality of cam lobes are arranged in contact with the plurality of cam lobe valleys, and wherein, in the disengaged state, the plurality of cam lobes are arranged out of contact with the plurality of cam lobe valleys and are in contact with the first contact surface of the body.

[0256] Any one or more of the above aspects further comprising: a first magnet disposed in the first magnetic recess, the first magnet comprising a first magnetic pole Petition 870250078665, dated 03 / 09 / 2025, p. 156 / 393 141 / 274 having a first polarity, the first magnetic pole facing away from the body of the interface plate; and a second magnet disposed in the second magnetic recess, the second magnet comprising a second magnetic pole having a second polarity, the second magnetic pole facing away from the cam body of the support bar, wherein the first magnetic pole faces the second magnetic pole, and wherein the first polarity is opposite to the second polarity. Any one or more of the above aspects include the fact that the support bar is held in the engaged state with the interface plate by a magnetic force between the first magnet and the second magnet, and wherein a first movement of the support bar relative to the interface plate causes the support bar to separate a distance from the interface plate and move the support bar from the engaged state with the interface plate to the disengaged state from the interface plate.Any one or more of the above aspects include where the first motion comprises a rotational motion about the longitudinal axis, and where the rotational motion comprises a force greater than the magnetic force. Any one or more of the above aspects, further comprising: a collection cradle fixed securely to the first end of the mandrel. Any one or more of the above aspects include the fact that the deflection side of the load moves independently of the support. Any one or more of the above aspects include where the plurality of cam lobe valleys comprises at least three cam lobe valleys arranged asymmetrically about an axis passing through a center of the first magnetic recess, and where the plurality of cam lobes comprises at least three cam lobes.Any one or more of the above aspects include where the at least three cam lobes engage with the at least three cam lobe valleys in a single rotational orientation around the axis passing through the center of the first magnetic recess. Any one or more of the aspects. Petition 870250078665, dated 03 / 09 / 2025, p. 157 / 393 142 / 274 above include where the support bar rotates around the longitudinal axis in the disengaged state without transmitting rotational force to the load cell via the interface plate.

[0257] Exemplary aspects are directed to a method of disengaging a support member from a balance assembly, comprising: providing a load cell assembly, comprising: a support; a load cell comprising a fixed side and a load deflection side offset from the fixed side, wherein the fixed side of the load cell is fixed to the support; an interface plate fixed to the load deflection side of the load cell, the interface plate comprising: a body; a first magnetic recess disposed in the body; and a plurality of cam lobe valleys at least partially around the first magnetic recess, wherein the plurality of cam lobe valleys interrupts a first contact surface of the body; a support bar comprising: a mandrel extending for a length along a longitudinal axis from a first end of the mandrel to a second end of the mandrel;a cam body disposed at the second end of the mandrel; a second magnetic recess disposed in the cam body; and a plurality of cam lobes extending from the cam body, the plurality of cam lobes disposed at least partially around the second magnetic recess; wherein the support bar is movable between an engaged state with the interface plate and a disengaged state from the interface plate, wherein, in the engaged state, the plurality of cam lobes is disposed in contact with the plurality of cam lobe valleys, and wherein, in the disengaged state, the plurality of cam lobes is disposed out of contact with the plurality of cam lobe valleys and is in contact with the first contact surface of the body; positioning the support bar in the engaged state with the interface plate so that the plurality of cam lobes is in contact with the plurality of cam lobe valleys; Petition 870250078665, dated 03 / 09 / 2025, page 158 / 393 143 / 274 cam lobes; receive a motion force on the support bar, causing the support bar to move from the engaged state to the disengaged state, wherein the motion force comprises a rotational force about the longitudinal axis; and move, while in the disengaged state, the support bar independently of the interface plate and without transmitting a specific rotational force to the interface plate and the load cell. EXAMPLE OF COMMUNICATION METHODS OF THE APHERESIS SYSTEM

[0258] In at least one embodiment, the apheresis system 200, as described in this document, may comprise one or more computer systems, such as computer system 1627. The processor 1630 of computer system 1627 may be configured to execute one or more of the processes and methods described in this document. The processor 1630 may run software. For example, the software may include firmware, applications, and / or operating systems that may manage the execution of the apheresis system 200.

[0259] The software, including firmware, applications, operating systems and other programmable resources of the 200 apheresis system, can be updated periodically to ensure that the 200 apheresis system is operating as required.

[0260] The 200 apheresis system may include an application that, among other things, performs fleet management and allows customers to install software for groups of devices. The software systems implemented by the 200 apheresis system may be configured to generate and / or compile device logs (D-logs) for submission to a cloud storage location. The D-logs may be used for predictive analytics or other purposes. Each 200 apheresis system may be in communication with a remote system server 1621 (e.g., via a communications network 1618, in the cloud, etc.), as illustrated in FIG. 16B. During initialization, Petition 870250078665, dated 03 / 09 / 2025, page 159 / 393 144 / 274 each apheresis system 200 can communicate information about the software, including a firmware version, error logs encountered, etc., to the server 1621 using a method as illustrated in FIG. 16A.

[0261] The 1621 system server can be configured to determine if the software and / or firmware version of the 200 apheresis system needs to be updated (e.g., is outdated, etc.). In at least one embodiment, the 1621 system server can force a software and / or firmware update automatically or give the user an option to update the software and / or firmware. In at least one embodiment, an external device can be connected to the 200 apheresis system to update the software. For example, the external device could be a computer or laptop configured to be connected to the 200 apheresis system and to update the 200 apheresis system software. In either case, if the software of a 200 apheresis system is not updated, the 200 apheresis system may be prevented from operating.This prevention can be based on a blocking signal sent by system server 1621 or on apheresis system 200 not receiving an unlock signal from system server 1621 that would allow operation.

[0262] The method of FIG. 16A can begin at 1600, at which time the apheresis system 200 can be in an off or unused state. At 16:03, the apheresis system 200 can be powered on and can undergo an initialization process. A computer system 1627, as illustrated in FIG. 16D, can be configured to detect an initialization of the apheresis system 200 or can be configured to automatically perform a process such as that described in this document upon initialization.

[0263] In response to initialization detection, computer system 1627 can transmit data to a server 1621 via a network connection 1618, as illustrated in Petition 870250078665, dated 03 / 09 / 2025, page 160 / 393 145 / 274 FIG. 16B. The data transmitted to server 1621 may comprise one or more data records, a firmware version identifier, and an error log.

[0264] At 4:09 PM, apheresis system 200 may receive a response from server 1621 in response to data transmitted to server 1621. Server 1621 may be configured to determine, based on the data, whether the software of apheresis system 200 is a current and / or updated version. If the software is outdated or not the current version, server 1621 may send a lockout signal or other type of data packet instructing apheresis system 200 to require a software update before use. In at least one embodiment, apheresis system 200 may not be usable until positive confirmation that the software is up-to-date is received from server 1621 via network connection 1618. In this way, the risks associated with using an outdated apheresis system 200 can be avoided. For example, at 4:12 PM, the use of apheresis system 200 can be avoided based on the response received from the server.

[0265] In at least one embodiment, if server 1621 determines that the software is outdated, the server may send, as part of its response, one or more files to update the software. Additionally or alternatively, the apheresis system 200 software may be updated automatically. For example, the software update may be initiated automatically after receiving one or more software update files from the server. In at least one embodiment, apheresis system 200 may allow a user to manually update the system once one or more software update files are received. For example, the user may manually initiate the software update after receiving one or more files. After the software update, apheresis system 200 may be configured to unlock and Petition 870250078665, dated 03 / 09 / 2025, page 161 / 393 146 / 274 allow the use of the system.

[0266] In at least one embodiment, the method illustrated in FIG. 16A may further comprise, after preventing the use of the apheresis machine, determining whether an unlocking requirement has been met. For example, the unlocking requirement may include the proper updating of the software. In response to the determination that the unlocking requirement has been met, the apheresis system 200 may enable use.

[0267] In at least one embodiment, a message may be displayed on a graphical user interface 1624 of the apheresis system 200, as illustrated in FIG. 16C. The message may inform the user whether the apheresis system 200 is locked due to outdated software and may allow the user to manually install a software update as needed. In at least one embodiment, the user may manually initiate the software update installation using the graphical user interface (GUI) 1624. In other embodiments, the user may connect an external device, including the software update, to the apheresis system 200 to initiate and install the software update.

[0268] At least one embodiment example includes a method comprising: detecting an initialization of an apheresis machine; in response to the initialization detection, transmitting data to the server; receiving, in response to the data, a response from the server; and based on the server's response, preventing the use of the apheresis machine.

[0269] Aspects of the above embodiment include those in which the data transmitted to the server comprises one or more data records, a firmware version identifier, and an error log. Aspects of the above embodiment include where the response comprises a lock signal. Aspects of the above embodiment include where the response comprises a firmware update. Aspects of the above embodiment include where the Petition 870250078665, dated 03 / 09 / 2025, page 162 / 393 147 / 274 firmware update is installed automatically. Aspects of the above embodiment include those in which the apheresis machine ceases to prevent use after the firmware update is installed. Aspects of the above embodiment include where the firmware update is installed manually by a user. Aspects of the above embodiment include, based on the server response, displaying a message in a graphical user interface. Aspects of the above embodiment include where the graphical user interface allows a user to initiate a firmware installation. Aspects of the above embodiment include, after preventing the use of the apheresis machine, determining that an unlocking requirement has been met; and, in response to the determination that the unlocking requirement has been met, allowing the use of the apheresis machine. Aspects of the above embodiment include where the unlocking requirement is associated with an updated firmware. EXAMPLES OF METHODS AND PROCESSES THAT PROVIDE FEEDBACK ON THE DONATION PROCESS

[0270] The apheresis system 200 may include one or more interface elements (e.g., display devices, LEDs, alarms, etc.) that provide indications to a user and / or the donor 102 about information regarding the donation process. In one example, these interfaces may indicate to the donor 102 that the donor 102 should squeeze (e.g., when the pressure or flow falls below a predetermined threshold, etc.). Additionally or alternatively, the interface elements may indicate to the donor 102 at what point in the donation process it is. In either case, this feedback may be provided in audible and / or visual output by the apheresis system 200 (e.g., by means of one or more loudspeakers, display devices, LEDs, etc.). In at least one embodiment, LEDs may be arranged on the side of the apheresis system 200 that provides this feedback to the donor 102. Petition 870250078665, dated 03 / 09 / 2025, page 163 / 393 148 / 274

[0271] The method illustrated by the flowchart in Fig. 17A can start at 1700. At the beginning of the method, an apheresis system, such as apheresis system 200, can be switched on and connected to a donor, such as donor 102.

[0272] At 5:03 p.m., a computer system of the apheresis system 200 can detect the start of a donation process. In at least one embodiment, no detection per se may be necessary, but instead, the method illustrated in Fig. 17A can be performed automatically as part of the donation process. For example, detecting the start of a donation process may include initiating the donation process. In at least one embodiment, detecting the start of the donation process may comprise detecting a fluid flow, for example, using one or more sensors, such as fluid sensor 316.

[0273] At 17:06, once the donation process has begun, the apheresis system can provide an output that is perceptible to donor 102. For example, the output may be a light, sound, GUI display, etc. The output may be provided within the view of donor 102. In at least one embodiment example, one side of the apheresis system 200 may include an output 1724, as illustrated in Fig. 17B. For example, output 1724 may comprise a series of lights, such as light-emitting diodes (LEDs). Although displayed as being on a specific side of the apheresis system 200, it should be understood that output 1724 may be on either side of the apheresis system 200 and may be within range of donor 102, so the output may be one or more of the options visualized and heard by donor 102.

[0274] In at least one embodiment, output 1724 may be a display device. For example, output 1724 may illuminate or glow so as to display to a donor, or other user of the apheresis system, information such as how much time remains in the donation process, whether the donor should press the Petition 870250078665, dated 03 / 09 / 2025, page 164 / 393 149 / 274 hand to improve blood flow in the apheresis system or other information. Output 1724 can be configured to illuminate or glow in a pulsating manner, in which a rate of light pulses can be synchronized with a rate at which the donor must squeeze their hand to achieve an ideal flow rate.

[0275] In 1709, the method may comprise determining a percentage of the donation process completed and / or remaining. For example, this may include determining the time remaining for the donation process. Determining an amount of time remaining may first comprise determining an amount of plasma expected to be donated by the donor 102. Determining the amount of plasma expected to be donated by the donor may involve receiving donor information as part of an initiation process. For example, donor information may be received from the donor identification card via a reader or scanner, such as the reader 1221 described above.

[0276] Determining the remaining time may involve dividing the amount of plasma expected to be donated by a donor by an expected flow rate. For example, if the 200 apheresis system determines that there is one liter of plasma expected to be donated, and that this plasma should be donated at a rate of one liter per minute, the 200 apheresis system may determine that there is one minute remaining for the donation process.

[0277] At 5:12 PM, the method can understand, in response to detecting the amount of time remaining for the donation process, to update the output.

[0278] In at least one embodiment, the output update, such as output 1724, may comprise the adjustment of a number of lights or a percentage of an illuminated display. For example, as illustrated in FIGS. 17C-17E, output 1724 may comprise five lights, 1727a-e. Each of the five lights 1727ae may be illuminated independently based on time. Petition 870250078665, dated 03 / 09 / 2025, page 165 / 393 150 / 274 remaining. Furthermore, as discussed above, the 1727ae lights can be pulsed, meaning the brightness of each light can be adjusted independently so that a pulsating effect can be achieved.

[0279] As illustrated in Fig. 17C, each light on output 1724 can be switched off or not illuminated to illustrate to the donor that the donation process has just begun. As illustrated in Fig. 17D, a subset of lights 1727a-e can be illuminated based on the amount of time remaining compared to the total time of the donation process. For example, if the donation process is sixty percent complete, sixty percent of the lights may be lit. As illustrated in Fig. 17E, each light on output 1724 can be illuminated to illustrate to the donor that the donation process is or is nearly complete. In at least one embodiment example, the color of lights 1727a-e on output 1724 can change after the donation process is complete.

[0280] At 5:15 PM, the method may involve detecting a pressure loss. Detecting a pressure loss may involve detecting that the pressure of a fluid in the apheresis machine 200 falls below a predetermined threshold. A pressure loss may be attributed to poor circulation in the donor 102, a collapsed vein, an underpowered pump, or other reasons. In some cases, the donor 102 may be required to squeeze their hand to increase the flow rate to the apheresis system 200. By squeezing their hand at a specific rate, the donor 102 may be able to control the flow rate to the apheresis system 200.

[0281] At 5:18 PM, in response to the detection of a pressure loss, the method may include updating output 1724. For example, in response to the detection of a pressure loss, apheresis system 200 may update output 1724 so that output 1724 instructs donor 102 to press. Updating output 1724 to instruct the donor to press may include flashing. By Petition 870250078665, dated 03 / 09 / 2025, p. 166 / 393 151 / 274 example, one or more 1727a-e lights can be switched on and off. In at least one embodiment example, the brightness of one or more 1727a-e lights can be pulsed at a specific rate. The rate at which the lights are pulsed or flashed can be based on a specific flow rate that needs to be achieved to complete the donation process.

[0282] In 1721, the method may terminate when the donation is complete. In at least one embodiment, the termination of the method may comprise the detection of the termination of the donation process. The termination of the method may include the shutdown of output 1724. For example, after detecting and terminating the donation process, the apheresis system 200 may perform an output routine, indicating to donor 102 that the donation process has been completed. Such an output routine may comprise one or more actions: flashing the lights of output 1724 in a specific order, changing the color of the lights of output 1724, generating a noise, or making some other perceptible output, which may indicate to donor 102 that the donation process has been completed. After the output routine, the device or system may stop making any noise and may turn off all lights.

[0283] In at least one embodiment, during a donation process, the apheresis system 200 can be configured to detect alarm events and, in response, alert a user about the alarm. For example, during a plasma donation process, a processor of a computer system or microcontroller within the apheresis system 200 can be configured to detect a factor such as temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors. If any of the factors are incorrect, too high, too low, etc., the processor can generate a graphical output that can alert the user about the alarm event and / or instruct them on how to resolve the alarm event.

[0284] Detection of an alarm event associated with a Petition 870250078665, dated 03 / 09 / 2025, page 167 / 393 152 / 274 The apheresis system may include monitoring factors such as temperature, pressure, flow rate, fluid color, weight of received plasma, data received from a scanner, motor control, centrifuge speed, software failure modes, and / or other factors related to the donation process.

[0285] Alarm event detection may involve receiving data from one or more sensors, such as temperature sensors, pressure sensors, flow sensors, color sensors, valve sensors, weight sensors, a scanner or other device.

[0286] Sensors can be placed throughout the 200 apheresis system and can be configured to monitor various aspects of the donation process, such as plasma donation vial weight, flow rates and pressures in the tubing, centrifuge speed and / or other elements.

[0287] The alarm event can be detected when one of the factors crosses a threshold or reaches a specific value. The threshold can be an upper or lower limit, or it can be a specific value or a range. If the alarm is related to a fluid color, for example, the threshold can be a specific color or a range of colors.

[0288] The limit may also be related to a time or time interval. For example, an alarm event may be detected when data received from a scanner, such as donor identification data, is outdated or expired. In at least one embodiment example, the alarm event may be detected when data received from the scanner indicates one or more expired instruments or devices, invalid instruments or devices, and incompatible instruments or devices.

[0289] In at least one embodiment, an alarm event may be based on data from multiple sensors. For example, an alarm event may occur when the pressure and the Petition 870250078665, dated 03 / 09 / 2025, page 168 / 393 153 / 274 temperatures exceed specific thresholds.

[0290] After detecting the alarm, the processor can generate or retrieve a graphical display output based on the detected alarm event.

[0291] Generating a graphical presentation output may include providing text describing the alarm event, providing one or more images describing the alarm event, and / or providing other content intended to instruct the user on how to resolve the alarm.

[0292] Retrieving a graphical display output may involve extracting from memory one or more texts describing the alarm event, one or more images describing the alarm event, and / or other content intended to instruct the user on how to resolve the alarm.

[0293] The instructions comprise at least one instruction to move the apheresis system 200 from an alarm state to an operational state. An instruction to move the apheresis system 200 from an alarm state to an operational state may comprise visual and / or text features informing the user of the steps that can be taken to resolve the problem underlying the alarm event. For example, the instructions may include information instructing a user to perform one or more actions: connect a tube, close a latch, and remove a twist from a tube. In at least one embodiment example, the instructions may include instructing the user to terminate the donation process and disconnect a donor from the apheresis system 200.

[0294] After generating and / or retrieving the graphical presentation output based on the detected alarm event, the processor can render the graphical presentation output to a graphical user interface of the apheresis system.

[0295] In at least one instance of mode, the processor may additionally or alternatively render the output of Petition 870250078665, dated 03 / 09 / 2025, p. 169 / 393 154 / 274 graphical presentation for a GUI, such as GUI 1230 shown in FIG. 12B; illuminating one or more light-emitting diodes (LEDs); and / or emitting an audible sound upon detecting the alarm event. The LEDs can be alternated between a plurality of colors, such as orange, yellow, red, and cyan. The color of the LEDs can be selected by the processor to correspond to the type of alarm event detected. In at least one embodiment example, the LEDs may include one or more lights 2339, as will be discussed below with respect to FIG. 22C.

[0296] In at least one example of a modality, each color can be associated with a different type and / or level of alarm. For example, an alarm type might indicate that the alarm is associated with one or more of the following factors: temperature, pressure, flow rate, color, and weight.

[0297] An alarm level can indicate, for example, the severity or priority of the alarm. In at least one example of a mode, different thresholds can be used to determine whether a specific factor is at a mild or severe level. For example, if a normal pressure is 10 PSI, a mild level alarm can be set for pressures below 5 PSI and a severe level alarm can be set for pressures of zero PSI. In at least one example of a mode, a high severity alarm can be red. In at least one example of a mode, a medium priority alarm can be yellow or orange. In at least one example of a mode, a low priority alarm can be green or blue. In at least one example of a mode, the light can be off or not illuminated if no alarm event is detected at the moment.

[0298] In at least one example of mode, the severity or priority level of the alarm may be indicated by the flashing or flickering of the light. The frequency at which the light flashes may also indicate the severity of the alarm. For example, a light flashing at a faster rate or frequency may have greater severity and Petition 870250078665, dated 03 / 09 / 2025, p. 170 / 393 155 / 274 priority, while a light flashing at a slower rate or frequency may have lower priority.

[0299] In at least one example of a mode, an audible alert or sound may indicate the severity level or priority of the alarm event. For example, multiple sounds, sound patterns, and sound frequencies may indicate a priority level. For example, higher frequency sounds may indicate higher priority alarm events, and lower frequency sounds may indicate lower priority alarm events. In at least one example of a mode, the rate at which a sound is emitted may indicate the severity level of the alarm event. For example, a sound that occurs, such as a beep, more frequently within a period of time may indicate a higher priority alarm event.

[0300] The alarm color can be set based on the alarm type and severity. For example, a temperature-related alarm might be a blue light, and the brightness or shade of the color can be adjusted based on the alarm severity.

[0301] In at least one embodiment, the graphical display output may include a date and time stamp indicating the time at which the alarm event occurred.

[0302] In at least one embodiment, the graphical presentation may comprise a description of the alarm and a list of actions to resolve the alarm.

[0303] In at least one embodiment, the output of the graphical presentation may comprise an illustration associated with the alarm event. For example, a photo or illustration may be displayed so that the user can be instructed on how to resolve the alarm state.

[0304] In at least one example of the modality, the graphical presentation comprises GUI elements that allow the user to reset, continue, and terminate the donation process.

[0305] In at least one example of a modality, after Petition 870250078665, dated 03 / 09 / 2025, page 171 / 393 156 / 274 Rendering the output of the graphical presentation, the method may comprise performing a system check. In at least one embodiment, the system check may be performed continuously during the donation process. Performing a system check may involve querying data associated with the alarm event to determine if the factor that caused the alarm event has returned to normal. If the factor that caused the alarm event returns to normal, the alarm may be resolved and terminated. In at least one embodiment, the alarm event may require the donation process to be terminated and the donor disconnected from the apheresis system 200. In such embodiments, the system check may determine that the alarm event may not be resolved or recoverable and may trigger an alarm and / or provide instructions to terminate the donation process and disconnect the donor 102.

[0306] For example, if a temperature falling below a predetermined threshold caused the alarm event, performing the system check may include determining whether the temperature is at or above the predetermined threshold.

[0307] At least one embodiment example includes a method comprising: detecting the start of a donation process; in response to detecting the start of the donation process, providing an output; determining the time remaining for the donation process; in response to detecting the time remaining for the donation process, updating the output; detecting a loss of pressure; in response to detecting the loss of pressure, updating the output; detecting the termination of the donation process; and in response to detecting the termination of the donation process, updating the output.

[0308] Aspects of the above modality include where the donation process is a plasma donation using an apheresis machine. Aspects of the above modality include where the detection of the start of the donation process comprises the detection of a flow of Petition 870250078665, dated 03 / 09 / 2025, page 172 / 393 157 / 274 fluid. Aspects of the above modality include where the output is one or more of a light and a sound. Aspects of the above modality include where the output is provided on one side of an apheresis machine. Aspects of the above modality include where the output is within a donor's range. Aspects of the above modality include those in which the output may be one or more of the options visualized and heard by the donor. Aspects of the above modality include where the output is a display device. Aspects of the above modality include where the display device displays a series of lights. Aspects of the above modality include where the series of lights is updated to illustrate to the donor the time remaining in the donation process. Aspects of the above modality include where the series of lights pulses to instruct the donor to squeeze. Aspects of the above modality include where the pulsing of the lights is of a rhythm associated with a rate at which the donor must squeeze to maintain pressure.Aspects of the above embodiment include where the detection of a pressure loss comprises detecting that the pressure of a fluid in the apheresis machine falls below a predetermined threshold. Aspects of the above embodiment include, in response to the detection of the pressure loss, the output update comprising instructing a donor to squeeze. Aspects of the above embodiment include, in response to the detection of the termination of the donation process, the output update comprising ceasing an audible noise or turning off a light.

[0309] At least one example of an embodiment of the present disclosure includes a method comprising: detecting an alarm event associated with an apheresis system, retrieving a graphical presentation output based on the detected alarm event, and rendering the graphical presentation output to a graphical user interface of the apheresis system.

[0310] Aspects of the above method include where the method is performed by an apheresis system being used to perform a plasma donation process. Aspects of the above method include Petition 870250078665, dated 03 / 09 / 2025, page 173 / 393 158 / 274 those in which the alarm event is related to one or more of the following factors: temperature; pressure; flow rate; fluid color; excessive amount of plasma received; and data received from a scanner. Aspects of the above method include where the alarm event is associated with outdated data received from the scanner. Aspects of the above method include where the alarm event is detected when one of the factors crosses a threshold. Aspects of the above method include where the detection of the alarm event comprises receiving data from one or more sensors. Aspects of the above method include where the retrieval of the graphical presentation output comprises the generation of the graphical presentation output. Aspects of the above method include where the graphical presentation output comprises instructions that describe the alarm event.Aspects of the above method include those in which the instructions comprise at least one instruction to move the apheresis system from an alarm state to an operational state. Aspects of the above method include those in which the instructions comprise instructing a user to connect a tube, close a latch, and remove a twist from a tube. Aspects of the above method include illuminating a light-emitting diode (LED) upon detection of an alarm event. Aspects of the above method include where a color of the light-emitting diode is selected by the processor to correspond to a type of alarm event detected; where the color is selected from orange, yellow, red, and cyan; and where the alarm type is associated with one or more of the following: temperature, pressure, flow rate, color, and weight. Aspects of the above method include, after rendering the graphical presentation output, performing a system check.Aspects of the above method include where performing the system verification involves searching for data associated with the alarm event. Aspects of the above method include where the output of the graphical presentation includes a date and time stamp indicating the time the alarm event occurred. Aspects of... Petition 870250078665, dated 03 / 09 / 2025, page 174 / 393 Aspects of the above method include where the graphical presentation output comprises an illustration associated with the alarm event. Aspects of the above method include where the illustration instructs the user to resolve the alarm state. Aspects of the above method include where the graphical presentation comprises a description of the alarm and a list of actions to resolve it. Aspects of the above method include where the graphical presentation comprises GUI elements that allow the user to reset, continue, and terminate the donation process. EXAMPLE OF A MODULAR SERVICE AND INTERCONNECTION SLEIGHBORHOOD

[0311] In at least one embodiment, an apheresis system (for example, apheresis system 200 or apheresis system 1800) includes one or more subsystems (for example, electrical power subassembly, pneumatic control subassembly, communications subassembly, pumps 208, 212, 216, flask tray load cell assembly 1500, etc.) that are attached to a sled, or mechanical structure, that can be completely separated from the apheresis system for servicing, maintenance and / or replacement. Modular maintenance sleds may include one or more mechanical and / or electrical interconnections that can be selectively decoupled from one or more mechanical and / or electrical interconnections of the apheresis system. Once decoupled, an entire subsystem on a specific modular maintenance sled can be removed from the apheresis system, for example, independently of other subsystems and modular maintenance sleds.

[0312] In at least one embodiment, the modular maintenance sled may be separated into discrete and / or combined subsystem sleds. For example, a modular maintenance sled may include a plurality of pneumatic systems (e.g., two or more manifolds, valves, etc.) for the apheresis system, another modular maintenance sled may include a plurality of electrical systems (e.g., two Petition 870250078665, dated 03 / 09 / 2025, page 175 / 393 160 / 274 or more processors, controllers, memory devices, power supplies, wiring harnesses, connectors, etc.) and / or other modular maintenance supports may comprise electrical and / or mechanical subsystems that are grouped based on anticipated and / or historical maintenance requirements.

[0313] In at least one embodiment, one or more of the pumps 208, 212, 216 (shown in FIG. 2A) can be quickly replaced by removing a limited number of fasteners (e.g., screws, nuts, bolts, etc.) associated with a respective modular maintenance sled. After removing the fastener(s), the entire respective modular maintenance sled and associated system (e.g., pump 208, 212, 216) can be removed from the apheresis system without requiring dismantling the apheresis system and / or removing other panels, structures, etc.

[0314] Among other things, these modular maintenance sleds can allow components to be quickly separated from the apheresis system and serviced separately from the apheresis system. In at least one embodiment, once a modular maintenance sled has been removed from the apheresis system, a different (e.g., new, refurbished, etc.) modular maintenance sled can be replaced in the apheresis system and the apheresis system can continue to operate (e.g., while the removed modular maintenance sled is being repaired, returned to manufacturing, or repaired / reworked). This approach can allow subsystems to be swapped out in one minute, providing, among other things, greater operability and less downtime for an apheresis system, when compared to the maintenance required for other apheresis systems, which can take hours or more to repair.

[0315] FIG. 18A is a partially exploded perspective view of an apheresis system including modular sleds of Petition 870250078665, dated 03 / 09 / 2025, p. 176 / 393 161 / 274 maintenance in accordance with at least one example modality.

[0316] In at least one embodiment, as shown in FIG. 18A, an apheresis system 1800 includes one or more modular maintenance sleds 1802. The apheresis system 1800 may be similar to the apheresis system 200 of FIG. 1A. At least in the example embodiment shown, the 1802 sleds include a first sled 1802A, a second sled 1802B, a third sled 1802C, a fourth sled 1802D, a fifth sled 1802E, a sixth sled 1802F, a seventh sled 1802G, an eighth sled 1802H, and a ninth sled 1802I (collectively referred to as “1802 sleds”). The 1800 apheresis system may further include a base set 1804. The base set 1804 may define a plurality of receiving spaces 1806. The receiving spaces 1806 may be defined on any surfaces (or multiple surfaces) of the base set 1804, including a top surface, side surfaces, and / or rear surfaces, etc.Each of the 1802 sleds may be at least partially within one of the 1806 receiving spaces. Each of the 1802 sleds may include a modular structure configured to be selectively coupled to the apheresis system, as will be described in greater detail below.

[0317] In at least one embodiment, the base assembly 1804 includes a housing 1804A and a frame 1804B. The housing 1804A may be made of plastic and the frame 1804B may be made of metal. In at least another embodiment, a base assembly may include an integral housing and frame. In at least one embodiment, the housing 1804A may include sloped or contoured regions 1807 on the peripheries of some or all of the receiving spaces 1806. The sloped or contoured regions 1807 may be configured to direct fluid away from the sled 1802 (e.g., a joint 1818 of the sled 1802) to reduce or prevent fluid buildup near the joint 1818 and / or facilitate Petition 870250078665, dated 03 / 09 / 2025, p. 177 / 393 162 / 274 cleaning of accommodation 1804A.

[0318] In at least one embodiment, the first modular maintenance sled 1802A includes an extraction pump. The extraction pump may be similar to or the same as extraction pump 208 of FIG. 2A. The extraction pump may be configured to have an electrical power connection, an electrical communication connection, and a pneumatic connection to the base assembly 1804. The first modular maintenance sled 1802A may have an environmental or fluid joint and a shielding component configured to engage the base assembly 1804.

[0319] In at least one embodiment, the second modular maintenance sled 1802B includes a return pump. The return pump may be similar to or the same as return pump 212 of FIG. 2A. The return pump may be configured to have an electrical power connection, an electrical communication connection, and a pneumatic connection to the base assembly 1804. The second modular maintenance sled 1802B may have an environmental or fluid joint and a shielding component configured to engage the base assembly 1804.

[0320] In at least one embodiment, the third modular maintenance sled 1802C includes an AC pump. The AC pump may be similar to or the same as the AC pump 216 of FIG. 2A. The AC pump may be configured to have an electrical power connection and an electrical communication connection to the base assembly 1804. The third modular maintenance sled 1802C may have an environmental or fluid joint and a shielding component configured to engage the base assembly 1804.

[0321] In at least one embodiment, the fourth sled 1802D includes a fluid valve control system. The fluid valve control system may be similar to or the same as fluid valve control system 228 of FIG. 2A. The fluid valve control system may be configured to have an electrical power connection, a connection Petition 870250078665, dated 03 / 09 / 2025, page 178 / 393 163 / 274 electrical communication and a pneumatic connection with base assembly 1804. The fourth modular maintenance sled 1802D may have an environmental or fluid joint and a shielding component configured to engage base assembly 1804.

[0322] In at least one embodiment, the fifth sled 1802E includes a bottle tray load cell assembly. The bottle tray load cell assembly may be similar to or the same as the 1500 load cell assembly of FIGS. 15A-15M. The bottle tray load cell assembly may be configured to have an electrical power connection and a signal connection to the base assembly 1804. The fifth modular maintenance sled 1802E may have an environmental or fluid joint and a shielding component configured to engage the base assembly 1804.

[0323] In at least one embodiment, the sixth sled 1802F includes a user interface device or screen. The user interface device may be configured to have an elect...

Claims

CLAIMS 1. A method CHARACTERIZED by the fact that it comprises: detecting, with a controller, the initialization of an apheresis machine based on signals received by the controller; in response to the initialization detection, automatically transmitting data to a server via the controller; automatically determining, via the server and based on the data, whether the apheresis machine software is up-to-date; automatically receiving a response from the server via the controller and in response to the data; and automatically preventing the use of the apheresis machine via the controller if the server's response indicates that the software is not up-to-date.

2. Method, according to claim 1, CHARACTERIZED in that the data transmitted from the controller to the server comprises one or more data logs, a firmware version identifier and an error log.

3. Method according to claim 1, characterized in that the response comprises a blocking signal.

4. Method according to claim 1, CHARACTERIZED in that the response comprises a software update.

5. Method according to claim 4, CHARACTERIZED in that the software update includes a firmware update.

6. Method according to claim 4, CHARACTERIZED in that it further comprises automatically initiating, by the controller, the installation of the software update.

7. Method, according to claim 6, CHARACTERIZED in that it further comprises interrupting the prevention of the use of the apheresis machine after the installation of the software update.

8. Method, according to claim 4, CHARACTERIZED Petition 870250078665, dated 03 / 09 / 2025, pp. 388 / 393 2 / 3 by the fact that it further comprises manually initiating the software update installation.

9. Method according to claim 1, CHARACTERIZED in that it further comprises, based on the server's response, the display of a message in a graphical user interface.

10. Method according to claim 9, characterized in that the graphical user interface allows a user to initiate a software installation.

11. Method, according to claim 1, CHARACTERIZED in that it further comprises: after preventing the use of the apheresis machine, automatically determining, with the controller, that an unlocking requirement has been met; and in response to the determination that the unlocking requirement has been met, allowing, with the controller, the use of the apheresis machine.

12. Method, according to claim 11, CHARACTERIZED in that the unlocking requirement is associated with updated software.

13. Method, according to claim 1, CHARACTERIZED in that the software includes one or more firmware, applications and operating systems.

14. Method according to claim 1, CHARACTERIZED in that it further comprises manually installing a software update.

15. Method according to claim 14, CHARACTERIZED in that the manual installation of the software update includes connecting an external device, including the software update, to the apheresis machine and installing the software update.

16. Method, according to claim 1, CHARACTERIZED by the fact that the automatic prevention, by the controller, of the use of the apheresis machine includes receiving a blocking signal from the server, the blocking signal including instructions to prevent the use of the apheresis machine until the software is updated.

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