Communication and operational control of blood component separation system

Abstract

A method includes: detecting activation of a blood component separation machine; in response to detecting the boot, transmitting data to a server; determining, based on the data, whether software of the blood component separation machine is a current version; receiving a response from the server in response to the data; and blocking the use of the blood component separation machine if the response indicates that the software is not the current version. The data transmitted to the server may include one or more of the following: a data log, a firmware version identifier, and an error log. The response may include a lock signal. The response may include a software update. The software update may include a firmware update. The method may include automatically initiating installation of a software update. The method may include unblocking the use of the blood component separation machine after installing the software update.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Patent Application No. 18 / 116,988, filed on March 3, 2023, which claims the benefit of priority to U.S. Provisional Application No. 63 / 318,683, filed on March 10, 2022. The entire contents of the above applications are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to communication and operational control of a blood component separation system. Background Art

[0004] This section provides background information related to the present disclosure which is not necessarily prior art.

[0005] There are two common methods for donating / collecting blood. The first common method involves obtaining a whole blood donation from a donor. Once the whole blood is obtained, a centrifugation process can be used, for example, to separate the blood components from the whole blood based on the densities of the different blood components. During and / or after the application of centrifugal force, the desired components can be moved manually, semi-automatically, or automatically into a collection container. The second common method is referred to as apheresis collection, which requires a dedicated machine. For example, apheresis methods can extract whole blood from a donor while the donor is connected to a dedicated apheresis machine. The whole blood can then be centrifuged to collect only the desired blood component (e.g., plasma), and all other blood components are returned to the donor during the same donation connection or cycle. During the separation and collection of the blood components, the donor is connected to the apheresis machine. Unfortunately, however, the apheresis process can be very time-consuming, which is uncomfortable for the donor. For example, donors typically must remain connected to the dedicated apheresis machine for an hour or more to complete their apheresis donation. Therefore, there is a need to develop processes and improve specialized blood component separation machines to increase the comfort and efficiency of the blood component donation process. Summary of the Invention

[0006] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0007] There is a need for a plasma or other blood component system that can reduce donation time and improve donor comfort. The embodiments presented herein can improve the efficiency of the donation process by using the separated blood components to return or drive unwanted blood components back to the donor without stopping and restarting the centrifuge. For example, in at least one exemplary embodiment, the present disclosure provides methods and apparatus for positioning portions of disposables (including, for example, loops) in medical devices. In at least one exemplary embodiment, the present disclosure provides systems, for example, including surfaces, for automatically guiding loops. In at least one exemplary embodiment, the present disclosure provides a medical device, for example, including a blood component separation machine, such as a blood separator.

[0008] In at least one exemplary embodiment, the present disclosure provides an assembly for separating components from a multi-component fluid. The assembly may include a filler and a loop rotation position guide. The filler may include a channel for holding a disposable separation capsule. The channel may include two opposing walls. The loop rotation position guide may include a plurality of bearings. When the separation capsule is loaded into the channel, the loop rotation position guide may hold a flexible loop of the disposable item. In at least one exemplary embodiment, the loop rotation position guide may include a stop plate. In at least one exemplary embodiment, when the flexible loop is held in the loop rotation position guide, the flexible loop may contact the stop plate. In at least one exemplary embodiment, the assembly may be part of a blood component separation machine. In at least one exemplary embodiment, the assembly may be connected to a rotor that rotates the loop rotation position guide about an axis of rotation. In at least one exemplary embodiment, the plurality of bearings may include a plurality of pairs of roller bearings.

[0009] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include a centrifuge housing having an outer surface and an inner cavity. The centrifuge housing can rotate about a rotational axis of the centrifuge assembly. The centrifuge assembly may include a fluid separation body at least partially disposed within the inner cavity of the centrifuge housing. The fluid separation body may be configured to rotate relative to the centrifuge housing about the rotational axis of the centrifuge assembly. The centrifuge assembly may include a fluid line circuit arm attached to a portion of the centrifuge housing and extending along the length of the outer surface of the centrifuge housing. The fluid line circuit arm may include a bearing assembly disposed at a point along the length of the outer surface, wherein the bearing assembly is configured to contact tubing portions of interconnected fluid line circuits and maintain the fluid line circuits in an engaged position relative to the centrifuge housing while allowing the fluid line circuits to rotate in the engaged position. In at least one exemplary embodiment, the bearing assembly may include a pair of roller bearings. In at least one exemplary embodiment, the bearing assembly may include multiple pairs of roller bearings. In at least one exemplary embodiment, the centrifuge assembly may be part of a blood component separation machine. In at least one exemplary embodiment, the fluid line circuit can be secured to a static, non-rotating portion of a blood component separation machine at a first end of the fluid line circuit by a first reliably positioned connector, and the fluid line circuit can be interconnected to a fluid separation body within an inner cavity at a second end of the fluid line circuit by a second reliably positioned connector. In at least one exemplary embodiment, the second end of the fluid line circuit can rotate with the fluid separation body. In at least one exemplary embodiment, the fluid line circuit can be physically and fluidically attached to a disposable fluid separation bladder at the second reliably positioned connector. In at least one exemplary embodiment, the fluid line circuit can include multiple lumens. In at least one exemplary embodiment, the fluid separation bladder can include a first flexible sheet attached to a second flexible sheet forming a fluid path, wherein a first portion of the fluid path can be narrower than a second portion of the fluid path.

[0010] In at least one exemplary embodiment, the present disclosure provides a method for automatically loading a fluid line loop into a centrifuge assembly. The method may include attaching a first end of the fluid line loop to a fluid separation body of the centrifuge assembly, and rotating the fluid separation body relative to the housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separation body can cause the fluid line loop to rotate relative to the housing and direct the fluid line loop into a channel of a loop arm attached to a portion of the housing. The channel may include bearings disposed in a bearing assembly attached to the loop arm. As the centrifuge assembly rotates, the bearings can maintain the fluid line loop in a position relative to the housing. In at least one exemplary embodiment, when the fluid line loop rotates within the channel relative to the housing, the bearings can contact a portion of the fluid line loop. In at least one exemplary embodiment, the centrifuge housing can rotate about a rotational axis at a first angular velocity in a first rotational direction, and the fluid separation body can rotate about the rotational axis at a different second angular velocity due to the torsional force provided by the fluid line loop. In at least one exemplary embodiment, the second angular velocity can be approximately twice the first angular velocity. In at least one exemplary embodiment, the fluid line loop can be physically and fluidically attached to a disposable fluid separation bladder that is at least partially disposed within the fluid separation body. In at least one exemplary embodiment, the method can further include attaching a second end of the fluid line loop to a rotationally fixed point of the blood component separation machine and rotating the centrifuge assembly about the rotational axis relative to the rotationally fixed point of the blood component separation machine (e.g., via a rotor and motor assembly of the blood component separation machine).

[0011] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components by blood component separation. The method may include drawing whole blood from a donor into a centrifuge; rotating the centrifuge so that centrifugal force acts on the whole blood, thereby separating the whole blood into at least a first blood component and a third blood component; separating the first blood component from the whole blood; extracting the first blood component into a container; detecting when a second blood component has been extracted; and after detecting the second blood component, forcing the separated first blood component back toward the centrifuge while the centrifuge continues to rotate, thereby removing at least the third blood component from the centrifuge and returning it to the donor. In at least one exemplary 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 exemplary 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 exemplary 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 exemplary 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 exemplary embodiment, the centrifuge may rotate at a first speed when separating a first blood component from whole blood. In at least one exemplary embodiment, the centrifuge may continue to rotate at the first speed when forcing the separated first blood component back toward the centrifuge. In at least one exemplary embodiment, the centrifuge may rotate at a second speed when whole blood from a donor is drawn into the centrifuge. In at least one exemplary embodiment, the second speed may include a speed slower than the first speed. In at least one exemplary embodiment, the first blood component may include a blood component separated from whole blood in a blood component collection device inserted into the centrifuge. In at least one exemplary embodiment, the centrifuge may include a filler that causes a blood component collection bag associated with the blood component collection device to rotate. In at least one exemplary embodiment, the blood component collection bag may be inserted into a collection insertion channel formed in the filler to hold the blood component collection bag.

[0012] In at least one exemplary embodiment, the present disclosure provides a blood component separation system. The blood component separation system may include: a first conduit having a lumen associated with a needle fluid, the lumen moving whole blood from a donor through the lumen; a suction pump coupled to the first conduit, the suction pump sucking the whole blood from the donor into a centrifuge; the centrifuge rotating to cause centrifugal force to act on the whole blood, thereby separating the whole blood into at least a first blood component and a third blood component; a blood component collection bag inserted into the centrifuge and fluidically connected to the first conduit, separating the first blood component from the whole blood; and a second conduit coupled to the blood collection bag fluidically. The centrifuge is provided with a centrifuge having a first blood component and a second blood component collection bag, wherein the first blood component is removed from the blood component collection bag; a collection container is fluidly associated with the second conduit and extracts the first blood component from the blood component separation system; a sensor is physically adjacent to the second conduit to detect when the second blood component is extracted from the whole blood; after the sensor detects the second blood component, while the centrifuge continues to rotate, a return pump coupled to the second conduit forces the separated first blood component back through the second conduit toward the blood component collection bag to move at least a third blood component from the blood component collection bag and return it to the donor. In at least one exemplary 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 exemplary embodiment, the blood component separation system may further include an anticoagulant pump configured to aspirate anticoagulant from an anticoagulant bag and mix the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first conduit. In at least one exemplary embodiment, the centrifuge may include a filler that rotates the blood component collection bag. In at least one exemplary embodiment, the blood component collection bag may be inserted into a collection insertion channel formed in the filler to hold the blood component collection bag.

[0013] In at least one exemplary embodiment, the present disclosure provides a blood component collection device associated with a blood component separation system. The blood component collection device may include: a needle that is inserted into a blood vessel of a donor to withdraw whole blood from the donor; a first conduit having a lumen fluidically associated with the needle to move whole blood through the lumen, wherein an aspiration pump engaged with the first conduit withdraws whole blood from the donor; a blood component collection bag that is inserted into a centrifuge and fluidically associated with the first conduit to separate a first blood component and a third blood component from the whole blood; a second conduit fluidly associated with the blood collection bag to remove the first blood component from the blood component collection bag; and a collection container fluidly associated with the second conduit to extract the first blood component from the blood component separation system, wherein a sensor is positioned physically proximate to the second conduit to detect when a second blood component is extracted from the whole blood; wherein after the sensor detects the second blood component, a return pump engaged with the second conduit forces the separated first blood component back through the second conduit toward the blood component collection bag while the centrifuge continues to rotate to move at least the third blood component from the blood component collection bag and return it to the donor. In at least one exemplary embodiment, the first blood component may include plasma and the second blood component may include platelets. In at least one exemplary embodiment, the suction pump may be disengaged when the reflux pump forces the separated first blood component back through the second conduit toward the blood component collection bag to move at least the third blood component from the blood component collection bag and return it to the donor. In at least one exemplary embodiment, the blood component collection bag may be inserted into and retained in a filler in a centrifuge that rotates the blood component collection bag. In at least one exemplary embodiment, the blood component collection bag may be inserted into a collection insertion channel formed in the filler to retain the blood component collection bag.

[0014] In at least one exemplary embodiment, the present disclosure provides a filler configured to accommodate a separation capsule in which a component is separated from a composite fluid. The filler may include a channel for holding the separation capsule during the separation of the component from the composite fluid. The channel may include a first wall and a second wall opposite the first wall. The first end of the channel may be adjacent to a central portion of the filler, and the channel extends spirally toward an outer periphery of the filler. In at least one exemplary embodiment, the top of the channel may be narrower than the middle portion of the channel. In at least one exemplary embodiment, at least a portion of the second wall may have a concave surface. In at least one exemplary embodiment, the second end of the channel may be positioned to withstand higher gravity during the separation process than the first end. In at least one exemplary embodiment, the top of the channel may provide reinforcement for the separation capsule during the separation process.

[0015] In at least one exemplary embodiment, the present disclosure provides a fluid separation filler. The fluid separation filler may include a body having an axis of rotation substantially disposed at the center of mass of the body and a fluid collection insertion channel disposed in the body and following a generally spiral path, the generally spiral path spirally extending outward from a first point adjacent the axis of rotation to a second point adjacent the periphery of the body. The fluid collection insertion channel may be offset outward toward the periphery of the body near the end of the generally spiral path, the generally spiral path defining a third point of the fluid collection insertion channel, the third point being disposed at a position farthest from the axis of rotation. In at least one exemplary embodiment, the fluid separation filler may also include a fluid collection chamber disposed within the body and following a portion of the generally spiral path, wherein the fluid collection insertion channel is connected to the fluid collection chamber to define an access area between an interior of the fluid collection chamber and an exterior of the body. In at least one exemplary embodiment, the fluid collection chamber may be configured to receive a disposable fluid collection capsule. In at least one exemplary embodiment, the dimension from the axis of rotation to the third point of the generally spiral path may be greater than the dimension from the axis of rotation to the second point of the generally spiral path. In at least one exemplary embodiment, the width of the fluid collection chamber at a point along the generally spiral path can be greater than the width of the fluid collection insertion channel at a point along the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber can further include a first wall and a second wall, the first wall following an innermost portion of the generally spiral path, the second wall being substantially parallel to the first wall and following an outermost portion of the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber can further include one or more tapered walls disposed between the first wall and the second wall, and the one or more tapered walls can be configured to guide the disposable fluid collection bladder into a seated position within the fluid collection chamber. In at least one exemplary embodiment, when the disposable fluid collection bladder is installed in the fluid collection chamber, the fluid inlet of the disposable fluid collection bladder can be disposed near the axis of rotation, a first fluid path in the disposable fluid collection bladder can follow the generally spiral path outward toward an end of the disposable fluid collection bladder, the end being disposed near a third point of the fluid collection insertion channel farthest from the axis of rotation, and can be fluidically interconnected with a second fluid path in the disposable fluid collection bladder, separate from the first fluid path, the second fluid path proceeding in a direction that follows the generally spiral path from the third point inward toward a fluid outlet of the disposable fluid collection bladder disposed adjacent the axis of rotation. In at least one exemplary embodiment, the fluid inlet and the fluid outlet can be part of a connector attached to a disposable fluid collection bladder, and the body of the fluid separation filler can include a connection point that engages with the connector. In at least one exemplary embodiment, the connector can include at least one key feature, wherein the connection point can include at least one mating key feature, and the key feature can reliably position the connector relative to the connection point.

[0016] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly may include: a centrifuge housing having an interior cavity and a fluid separation body, wherein the centrifuge housing rotates about a rotational axis of the centrifuge assembly, and the fluid separation body is at least partially disposed within the interior cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the rotational axis. The fluid separation body may include a fluid collection insert channel disposed in the fluid separation body, the fluid collection insert channel following a generally spiral path extending spirally outward from a first point adjacent to the rotational axis to a second point disposed adjacent to a periphery of the fluid separation body. In at least one exemplary embodiment, the fluid separation body may further include a fluid collection chamber disposed within the body and following a portion of the generally spiral path, wherein the fluid collection insert channel may be connected to the fluid collection chamber to define an access area between an interior of the fluid collection chamber and an exterior of the fluid separation body. In at least one exemplary embodiment, the centrifuge assembly may further include a disposable fluid collection sac disposed within the fluid collection chamber following the generally spiral path. The disposable fluid collection sac may include a fluid inlet disposed near the axis of rotation, a first fluid path in the disposable fluid collection sac may follow a generally spiral path outward toward an end of the disposable fluid collection sac, the end being disposed near a third point of the fluid collection insertion channel farthest from the axis of rotation, and may be fluidically interconnected with a second fluid path in the disposable fluid collection sac that is separate from the first fluid path, the second fluid path proceeding in a direction that follows a generally spiral path from the third point inward toward a fluid outlet of the disposable fluid collection sac disposed adjacent to the axis of rotation. In at least one exemplary embodiment, the centrifuge assembly may be part of a blood component separation machine. In at least one exemplary embodiment, the centrifuge housing may be divided into an upper housing and a lower housing, wherein the upper housing may include an inner cavity, the upper housing may be rotatable between an open state and a closed state about a pivot axis offset from the axis of rotation and substantially perpendicular to the axis of rotation, and the fluid collection insertion channel of the fluid separation body is accessible in the open state and inaccessible in the closed state.

[0017] In at least one exemplary embodiment, the present disclosure provides a blood component collection circuit. The blood component collection circuit may include: a flexible circuit; a system static circuit connector disposed at a first end of the flexible circuit, wherein the system static circuit connector is connected to a fixed circuit connector of a centrifuge to secure the first end of the flexible circuit for synchronous rotation with the centrifuge; and a filler circuit connector disposed at a second end of the flexible circuit, opposite the first end, wherein the filler circuit connector is connected to a circuit connection region of a filler, wherein a torsional force based on torsion in the flexible circuit is applied to the filler via the filler circuit connector, and wherein the flexible circuit rotationally moves to be captured by a circuit rotation position guide positioned on the centrifuge. In at least one exemplary embodiment, the blood component collection circuit may be part of a blood component collection device, and the blood component collection device may be associated with a blood component separation system. In at least one exemplary embodiment, the circuit rotation position guide may be attached to a rotor that rotates the circuit rotation position guide and the flexible circuit about a rotation axis. In at least one exemplary embodiment, the blood component collection circuit may be positioned at least partially by a circuit position stop plate. In at least one exemplary embodiment, the flexible circuit may bend around the centrifuge. In at least one exemplary embodiment, the flexible circuit can also be held in place by a circuit containment bracket. In at least one exemplary embodiment, at least a portion of the circuit rotational position guide can include a circuit torsion support bearing. In at least one exemplary embodiment, the circuit torsion support bearing can include a pair of roller bearings. In at least one exemplary embodiment, the circuit torsion support bearing can allow the flexible circuit to twist. In at least one exemplary embodiment, the twisting can cause the filler to rotate at an angular velocity greater than that of a centrifuge. In at least one exemplary embodiment, the flexible circuit can include two or more lumens to move whole blood and / or blood components within the flexible circuit.

[0018] In at least one exemplary embodiment, the present disclosure provides an assembly for loading a flexible circuit. The assembly may include a circuit rotation position guide including a channel for holding a flexible circuit of a blood component collection device; a circuit torsional support bearing disposed in the channel and on a portion of the circuit rotation position guide to support the flexible circuit; and a circuit capture arm, wherein the circuit capture arm 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 torsional support bearing. In at least one exemplary embodiment, the assembly may be part of a blood component separation machine, wherein the circuit rotation position guide may be attached to a centrifuge that rotates the circuit rotation position guide and the flexible circuit about a rotation axis. In at least one exemplary embodiment, the circuit rotation position guide may further include a circuit position stop plate to further position the flexible circuit. In at least one exemplary embodiment, the assembly may further include a circuit containment bracket, located in the same plane as the circuit rotation position guide and disposed on the centrifuge to further capture the flexible circuit.

[0019] In at least one exemplary embodiment, the present disclosure provides a method for automatically loading a flexible circuit into an assembly. The method may include: connecting a system static circuit connector disposed at a first end of the flexible circuit to a fixed circuit connector of a centrifuge to secure the first end of the flexible circuit for synchronous rotation with the centrifuge; connecting a filler circuit connector disposed at a second end of the flexible circuit, opposite the first end, to a circuit connection area of ​​the filler, wherein a torsional force based on torsion in the flexible circuit is applied to the filler via the filler circuit connector; and rotationally moving the flexible circuit into a circuit rotation position guide located on the centrifuge. In at least one exemplary embodiment, the flexible circuit may engage a circuit torsion support bearing disposed in a channel formed by the circuit rotation position guide, wherein the circuit torsion support bearing supports the flexible circuit. In at least one exemplary embodiment, a circuit capture arm may contact the flexible circuit during rotation to guide the flexible circuit into the channel and into contact with the circuit torsion support bearing. In at least one exemplary embodiment, the circuit rotation position guide may further include a circuit position stop plate to prevent the flexible circuit from excessively rotating through the channel. In at least one exemplary embodiment, a circuit containment bracket disposed on the centrifuge and located in the same plane as the circuit rotation position guide may further capture and retain the flexible circuit.

[0020] In at least one exemplary embodiment, the present disclosure provides a soft box. The soft box may include: a first box port; a second box port; a direct current lumen fluidly connected to the first box port and the second box port; a drip chamber, the drip chamber being disposed in the direct current lumen such that fluid passing through the direct current lumen passes through the drip chamber; and a fluid flow bypass path, the fluid flow bypass path being fluidly connected to the direct current lumen adjacent to the first box port and located between the first box port and the drip chamber, and also being fluidly connected to the direct current lumen adjacent to the second box port and located between the second box port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch fluidly connected to the direct current lumen adjacent to the first box port and a second bypass branch fluidly connected to the direct current lumen adjacent to the second box port. In at least one exemplary embodiment, the fluid flow bypass path may further include a fluid pressure ring disposed between the first bypass branch and the second bypass branch and fluidly connected to the first bypass branch and the second bypass branch. In at least one exemplary embodiment, the direct flow lumen may include a first compliance region disposed between a first connector connected to the first bypass branch and the drip chamber, allowing the first fluid control valve to occlude the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen may include a second compliance region disposed between a second connector connected to the second bypass branch and the drip chamber, allowing the second fluid control valve to occlude the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen may include a third compliance region disposed in the first bypass branch, allowing the aspiration fluid control valve to occlude the first bypass branch. In at least one exemplary embodiment, the first cartridge port may be fluidically connected to a cartridge inlet tube that moves fluid from a donor to a soft cartridge or from a soft cartridge to a donor, and the second cartridge port may be fluidically connected to a circuit inlet tube that moves fluid from the soft cartridge to a centrifuge or from a centrifuge to a soft cartridge. In at least one exemplary embodiment, when fluid is aspirated from a donor, fluid may pass through the fluid flow bypass path. In at least one exemplary embodiment, when fluid is returned to the donor, the fluid can pass through the direct flow lumen. In at least one exemplary embodiment, when fluid is withdrawn from the donor in a subsequent aspiration, a portion of the fluid previously delivered to the donor through the direct flow lumen can remain in the drip chamber as the fluid passes through the fluid flow bypass path. In at least one exemplary embodiment, the softbox can be part of a blood component collection device. In at least one exemplary embodiment, the blood component collection device can be part of a blood component separation system.

[0021] In at least one exemplary embodiment, the present disclosure provides a blood component collection device. The blood component collection device may include: a centrifuge to separate blood components from whole blood; a cartridge inlet tube fluidically connected to a donor; a circuit inlet tube fluidically connected to the centrifuge; a soft cartridge comprising a first cartridge port fluidically connected to the cartridge inlet tube; a second cartridge port fluidically connected to the circuit inlet tube; a flow path lumen fluidically connected to the first cartridge port and the second cartridge port; a drip chamber disposed in the flow path lumen such that fluid passing through the flow path lumen passes through the drip chamber; and a fluid flow bypass path fluidically connected to both the flow path lumen adjacent to the first cartridge port and located between the first cartridge port and the drip chamber, and to the flow path lumen adjacent to the second cartridge port and located between the second cartridge port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch fluidically connected to a flow lumen adjacent to the first cartridge port, a second bypass branch fluidically connected to a flow lumen adjacent to the second cartridge port, and a fluid pressure ring disposed between the first bypass branch and the second bypass branch and fluidically connected to the first bypass branch and the second bypass branch. In at least one exemplary embodiment, the flow lumen may include a first compliance region disposed between a first connector connected to the first bypass branch and a drip chamber, allowing the first fluid control valve to occlude the flow lumen, wherein the flow lumen includes a second compliance region disposed between a second connector connected to the second bypass branch and the drip chamber, allowing the second fluid control valve to occlude the flow lumen, wherein the flow lumen includes a third compliance region disposed in the first bypass branch, the third compliance region allowing the aspiration fluid control valve to occlude the first bypass branch. In at least one exemplary embodiment, when aspirating fluid from a donor, the first fluid control valve and the second fluid flow control valve can close and block the direct flow lumen, and the aspiration fluid control valve can open and allow whole blood to pass through the fluid flow bypass path. In at least one exemplary embodiment, when returning fluid to the donor, the first fluid control valve and the second fluid flow control valve can open and allow fluid to pass through the direct flow lumen, and the aspiration fluid control valve can close and block the fluid flow bypass path. In at least one exemplary embodiment, when aspirating fluid from the donor in a subsequent aspiration, a portion of the fluid previously delivered to the donor through the direct flow lumen can remain in the drip chamber as the fluid passes through the fluid flow bypass path.

[0022] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a flexible cartridge. The method may include providing a flexible cartridge, wherein the flexible cartridge includes a first cartridge port fluidly connected to a cartridge inlet tube; a second cartridge port fluidly connected to a circuit inlet tube; a flow path lumen fluidly connected to the first cartridge port and the second cartridge port; a drip chamber disposed within the flow path lumen such that fluid passing through the flow path lumen passes through the drip chamber; and a fluid flow bypass path fluidly connected to both the flow path lumen adjacent to the first cartridge port and located between the first cartridge port and the drip chamber, and to the flow path lumen adjacent to the second cartridge port and located between the second cartridge port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the method may include, when drawing whole blood from a donor, receiving whole blood from the cartridge inlet tube at the first cartridge port fluidly connected to the cartridge inlet tube, moving the whole blood to the second cartridge port through the fluid flow bypass path, and preventing the whole blood from moving through the flow path lumen. In at least one exemplary embodiment, the method may include, when returning the red blood cells to the donor, receiving the red blood cells from the circuit inlet tube at a second cartridge port fluidly connected to the circuit inlet tube, moving the red blood cells to the first cartridge port through the direct flow lumen and the drip chamber, and preventing the red blood cells from moving through the fluid flow bypass path. In at least one exemplary embodiment, when fluid is withdrawn from the donor in a subsequent aspiration, a portion of the previous fluid may be returned to the donor through the direct flow lumen, and also when returning the red blood cells to the donor.

[0023] In at least one exemplary embodiment, the present disclosure includes a method comprising: detecting activation of a blood component separation machine; in response to detecting the activation, transmitting data to a server; determining whether software of the blood component separation machine is current based on the data; receiving a response from the server in response to the data; and preventing use of the blood component separation machine if the response indicates that the software is not current.

[0024] In at least one exemplary embodiment, the data transmitted to the server includes one or more of the following: a data log, a firmware version identifier, and an error log.

[0025] In at least one exemplary embodiment, the response includes a lock signal.

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

[0027] In at least one exemplary embodiment, the software update comprises a firmware update.

[0028] In at least one exemplary embodiment, the method includes automatically initiating installation of the software update.

[0029] In at least one exemplary embodiment, the method includes, after installing the software update, unblocking use of the apheresis machine.

[0030] In at least one exemplary embodiment, the method includes manually initiating installation of the software update.

[0031] In at least one exemplary embodiment, the method includes displaying a message on a graphical user interface based on the response from the server.

[0032] In at least one exemplary embodiment, the graphical user interface enables a user to initiate software installation.

[0033] In at least one exemplary embodiment, the method includes, after preventing use of the blood component separation machine, determining that an unlock requirement has been met; and enabling use of the blood component separation machine in response to determining that the unlock requirement has been met.

[0034] In at least one exemplary embodiment, the unlock requirement is associated with updated software.

[0035] In at least one exemplary embodiment, software includes one or more of: firmware, applications, and an operating system.

[0036] In at least one example embodiment, the method includes manually installing the software update.

[0037] In at least one exemplary embodiment, manually installing the software update includes connecting an external device including the software update to the apheresis machine and installing the software update.

[0038] Depending on certain aspects, embodiments, and / or configurations, the present disclosure provides numerous advantages. For example, in at least one exemplary embodiment, by adjusting the rotational speed of the centrifuge during the process of returning unwanted blood components to the donor, the time for the blood component separation process can be shortened, for example, by about 30% or more. This increased efficiency can make donations faster and more comfortable. With the shortened donation time, a donation center may receive more donations on a typical day, thereby increasing productivity and revenue. In addition, if donations are made faster, donors are more likely to donate again. Faster donations can also enable a donation center to attract donors who would otherwise use other donation centers with slower donation rates.

[0039] Other areas of applicability will become apparent from the description provided in this disclosure.The description and specific examples in this summary are for purposes of illustration only and are not intended to limit the scope of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0041] Figure 1 illustrates a perspective view of an operating environment of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0042] Figure 2A yes Figure 1 A perspective view of a blood component separation system shown in ;

[0043] Figure 2B is a first detailed perspective view of a pump of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0044] Figure 2C is a second detailed perspective view of a pump of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0045] Figure 2D is a detailed perspective view of a fluid valve control system according to at least one exemplary embodiment of the present disclosure;

[0046] Figure 3A is a detailed perspective view of a disposable softbox assembly according to at least one embodiment of the present disclosure;

[0047] Figure 3B is a perspective view of a disposable softbox according to at least one embodiment of the present disclosure;

[0048] Figure 3C According to at least one exemplary embodiment of the present disclosure Figure 3B A vertical sectional view taken along line 3C in FIG.

[0049] Figure 3D According to at least one exemplary embodiment of the present disclosure Figure 3B The vertical section view taken by the line 3D;

[0050] Figure 4A shows a perspective view of a centrifuge assembly in a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0051] Figure 4B Shown Figure 4A A front perspective view of the centrifuge assembly shown in ;

[0052] Figure 4C Shown Figure 4A a rear perspective view of the centrifuge assembly shown in ;

[0053] Figure 4Dis a schematic cross-sectional view of a centrifuge assembly in a closed state according to at least one exemplary embodiment of the present disclosure;

[0054] Figure 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;

[0055] Figure 4F is a schematic cross-sectional view of a centrifuge assembly in an open state according to at least one exemplary embodiment of the present disclosure;

[0056] Figure 4G shows a perspective view of a centrifuge filler according to at least one exemplary embodiment of the present disclosure;

[0057] Figure 4H is a plan view of a centrifuge packing according to at least one exemplary embodiment of the present disclosure;

[0058] Figure 4I is a schematic plan view of a generally spiral receiving passage of a filler according to at least one exemplary embodiment of the present disclosure;

[0059] Figure 4J It is along Figure 4H An elevational sectional view taken along line 4J in FIG.

[0060] Figure 4K is a detailed cross-sectional view of a portion of a channel in a filler according to at least one exemplary embodiment of the present disclosure;

[0061] Figure 4L Shows the settings Figure 4K Different states of the fluid collecting sacs within the channels of the filler;

[0062] Figure 5A A fluid component collection device including a fluid component collection circuit according to at least one exemplary embodiment of the present disclosure is shown;

[0063] Figure 5B A fluid component collection circuit including a fluid component collection capsule according to at least one exemplary embodiment of the present disclosure is shown;

[0064] Figure 5C shows a cross-sectional view of a fluid component collection capsule according to at least one exemplary embodiment of the present disclosure;

[0065] Figure 5D shows another cross-sectional view of a fluid component collection capsule according to at least one exemplary embodiment of the present disclosure;

[0066] Figure 5Eshows a perspective view of a fluid component collection circuit in a bent state according to at least one exemplary embodiment of the present disclosure;

[0067] Figure 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;

[0068] Figure 5G shows a perspective view of a fluid component collection circuit loaded into a filler according to at least one exemplary embodiment of the present disclosure;

[0069] Figure 5H shows a perspective view of a fluid component collection circuit loaded in a filler according to at least one exemplary embodiment of the present disclosure;

[0070] Figure 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;

[0071] Figure 6B shows a schematic cross-sectional view of a centrifuge assembly in a second circuit loading state according to at least one exemplary embodiment of the present disclosure;

[0072] Figure 6C shows a schematic cross-sectional view of a centrifuge assembly in a third circuit loading state according to at least one exemplary embodiment of the present disclosure;

[0073] Figure 7A shows a schematic plan view of a centrifuge assembly in a circuit loading state according to at least one exemplary embodiment of the present disclosure;

[0074] Figure 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;

[0075] Figure 8 is a functional diagram of an embodiment of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0076] Figure 9 is a block diagram of an electrical system of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0077] Figure 10 is another block diagram of an electrical system of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0078] Figure 11 is another block diagram of an electrical system of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0079] Figure 12A is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0080] Figure 12B A blood component separation system with a scanner according to at least one exemplary embodiment of the present disclosure is shown;

[0081] Figure 12C shows a bottle according to at least one exemplary embodiment of the present disclosure;

[0082] Figure 12D shows a graphical user interface according to at least one exemplary embodiment of the present disclosure;

[0083] Figure 13A is an isometric view of a plasma collection vial holder according to at least one exemplary embodiment of the present disclosure;

[0084] Figure 13B is a flow chart according to at least one exemplary embodiment of the present disclosure;

[0085] Figure 14A is a perspective view of a mobile circuit holder of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0086] Figure 14B yes Figure 14A A partial view of the mobile loop retainer shown in ;

[0087] Figure 14C It is along Figure 14B An elevational cross-sectional view taken along line 14C as shown in FIG.

[0088] Figure 14D is a partial view of a mobile loop retainer in an extended position according to at least one exemplary embodiment of the present disclosure;

[0089] Figure 14E is a partial view of a mobile loop retainer in a retracted position according to at least one exemplary embodiment of the present disclosure;

[0090] Figure 14F is a partial view of a moving circuit holder in a retracted position and a cover of a centrifuge assembly in a blood component separation system in an open position according to at least one exemplary embodiment of the present disclosure;

[0091] Figure 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment of the present disclosure;

[0092] Figure 15B According to at least one exemplary embodiment of the present disclosure Figure 15AAn exploded perspective view of the load cell assembly in FIG.

[0093] Figure 15C According to at least one exemplary embodiment of the present disclosure Figure 15A a top perspective view of a mounting plate of a load cell assembly;

[0094] Figure 15D According to at least one exemplary embodiment of the present disclosure Figure 15C A bottom perspective view of the mounting plate in FIG;

[0095] Figure 15E According to at least one exemplary embodiment of the present disclosure Figure 15A A perspective view of a bracket for a load cell assembly;

[0096] Figure 15F According to at least one exemplary embodiment of the present disclosure Figure 15A A perspective view of a load cell assembly in FIG.

[0097] Figure 15G According to at least one exemplary embodiment of the present disclosure Figure 15A A perspective view of a load interface board of a load cell assembly;

[0098] Figure 15H According to at least one exemplary embodiment of the present disclosure Figure 15A A perspective view of an overload support rod of a load cell assembly;

[0099] Figure 15I According to at least one exemplary embodiment of the present disclosure Figure 15A A partial cross-sectional view of the load cell assembly in an engaged state;

[0100] Figure 15J According to at least one exemplary embodiment of the present disclosure Figure 15A A partial cross-sectional view of the load cell assembly in a disengaged state, wherein a portion of the first magnet is cut away;

[0101] Figure 15K According to at least one exemplary embodiment of the present disclosure Figure 15A a side elevation view of a bracket for a load cell assembly;

[0102] Figure 15L According to at least one exemplary embodiment of the present disclosure Figure 15K Front elevation of the bracket in;

[0103] Figure 15M According to at least one exemplary embodiment of the present disclosure Figure 15K A perspective view of a container in a bracket in FIG.

[0104] Figure 16A is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0105] Figure 16B shows a blood component separation system connected to a network according to at least one exemplary embodiment of the present disclosure;

[0106] Figure 16C A graphical user interface according to at least one exemplary embodiment of the present disclosure is shown;

[0107] Figure 16D is a block diagram of a computing system according to at least one exemplary embodiment of the present disclosure;

[0108] Figure 17A is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0109] Figure 17B A blood component separation system according to at least one exemplary embodiment of the present disclosure is shown;

[0110] Figures 17C to 17E An output device according to at least one exemplary embodiment of the present disclosure is shown;

[0111] Figure 18A is a partially exploded perspective view of a blood component separation system including a modular serviceable carriage according to at least one exemplary embodiment of the present disclosure;

[0112] Figure 18B is a schematic elevational cross-sectional view of a modular serviceable carriage in a disengaged state from a base of a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0113] Figure 18C According to at least one exemplary embodiment of the present disclosure Figure 18A A bottom perspective view of a return pump assembly of a blood component separation system;

[0114] Figure 18D According to at least one exemplary embodiment of the present disclosure Figure 18C A schematic elevational cross-sectional view of a modular serviceable carriage in a state engaged with a blood component separation system base;

[0115] Figure 18E A flow chart illustrating a method of servicing a blood component separation system according to at least one exemplary embodiment of the present disclosure;

[0116] Figure 19A is a perspective view of a collection bottle according to at least one exemplary embodiment of the present disclosure;

[0117] Figure 19B According to at least one exemplary embodiment of the present disclosure Figure 19A An elevational view of a collection bottle in a plasma collection tray placed in a blood component separation system;

[0118] Figure 19C yes Figure 19A A perspective view of the tank containing the collecting bottles;

[0119] Figure 19D yes Figure 19A A top view of the cover of the collection bottle;

[0120] Figure 19E yes Figure 19A A bottom view of the cover of the collection bottle;

[0121] Figure 19F According to at least one exemplary embodiment of the present disclosure Figure 19A A partial cross-sectional view of the collection bottle before collection (i.e., before use);

[0122] Figure 19G According to at least one exemplary embodiment of the present disclosure Figure 19A A partial view of the collecting bottle after collection (i.e., after use);

[0123] Figure 19H is an elevational view of a collection bottle transport package including multiple rows of filled collection bottles (ie, after collection) according to at least one exemplary embodiment of the present disclosure;

[0124] Figure 19I According to at least one exemplary embodiment of the present disclosure Figure 19A A side view of a collecting bottle disposed in a collecting bracket;

[0125] Figure 19J yes Figure 19A A perspective view of a collecting bottle in FIG. 1 being arranged in a collecting bracket;

[0126] Figure 20 is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0127] Figure 21A According to at least one exemplary embodiment of the present disclosure Figure 18A A partial perspective view of a blood component separation system;

[0128] Figure 21B According to at least one exemplary embodiment of the present disclosure Figure 21A An elevational view of a first hanger assembly of a blood component separation system;

[0129] Figure 21C According to at least one exemplary embodiment of the present disclosure Figure 21B an exploded perspective view of the first hanger assembly;

[0130] Figure 21D According to at least one exemplary embodiment of the present disclosure Figure 21A An elevational view of a second hanger assembly of a blood component separation system;

[0131] Figure 21E According to at least one exemplary embodiment of the present disclosure Figure 21D an exploded perspective view of the second hanger assembly;

[0132] Figure 21F According to at least one exemplary embodiment of the present disclosure Figure 21A A perspective view of an air assembly of a blood component separation system;

[0133] Figure 21G According to at least one exemplary embodiment Figure 21A A partial perspective view of a centrifuge housing of a blood component separation system;

[0134] Figure 21H According to at least one exemplary embodiment of the present disclosure Figure 21A A perspective view of a centrifuge assembly of a blood component separation system in a lid locked state;

[0135] Figure 21I According to at least one exemplary embodiment of the present disclosure Figure 21H A partially exploded perspective view of a locking engaging plate and a locking assembly of a centrifuge;

[0136] Figure 21J According to at least one exemplary embodiment of the present disclosure Figure 21H A perspective view of a cover engagement plate of a centrifuge assembly in FIG.

[0137] Figure 21K According to at least one exemplary embodiment of the present disclosure Figure 21H a perspective view of a cover of a centrifuge assembly in FIG.

[0138] Figure 21L According to at least one exemplary embodiment of the present disclosure Figure 21H A perspective view of the base of the centrifuge assembly;

[0139] Figure 21M According to at least one exemplary embodiment of the present disclosure Figure 21H A partial bottom perspective view of the centrifuge assembly in a locked state;

[0140] Figure 21NAccording to at least one exemplary embodiment of the present disclosure Figure 21M A partial bottom perspective view of the centrifuge assembly in an unlocked state;

[0141] Figure 21O According to at least one exemplary embodiment of the present disclosure Figure 21H A perspective view of the compressor assembly in a cover unlocked state;

[0142] Figure 22A is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0143] Figure 22B is a flow chart of a method according to at least one exemplary embodiment of the present disclosure;

[0144] Figure 22C A centrifuge chamber according to at least one exemplary embodiment of the present disclosure is shown;

[0145] Figure 23A is an elevational cross-sectional view of a flexible-based pipeline status sensor according to at least one exemplary embodiment of the present disclosure;

[0146] Figure 23B yes Figure 23A A perspective view of a flexible block of a flexible-based pipeline condition sensor;

[0147] Figure 23C It is time to Figure 23B Schematic diagram of the exaggerated displacement of the flexible block when pressure is applied to the pipe segment engaged by the flexible block;

[0148] Figure 23D is a perspective view of another example of a flexible block of a flexible-based pipeline state sensor according to at least one exemplary embodiment of the present disclosure;

[0149] Figure 24A According to the examples of the present disclosure Figure 5A A front view of a blood component collection circuit;

[0150] Figure 24B According to at least one exemplary embodiment Figure 24A An elevation view of the blood component collection circuit in a first folded state;

[0151] Figure 24C According to at least one exemplary embodiment Figure 24A An elevation view of the blood component collection circuit in a second folded state;

[0152] Figure 24D According to at least one exemplary embodiment Figure 24AAn elevation view of the blood component collection circuit in the third folded state;

[0153] Figure 24E is a bottom plan view of a blood component collection circuit with a folded and wrapped bladder according to at least one exemplary embodiment of the present disclosure;

[0154] Figure 24F According to at least one exemplary embodiment Figure 5A A perspective view of a blood component collection device in FIG.

[0155] Figure 24G According to at least one exemplary embodiment Figure 24F A perspective view of a blood component collection circuit without a sealing tape wrap;

[0156] Figure 24H According to at least one exemplary embodiment Figure 24A A top plan view of a blood component collection circuit;

[0157] Figure 24I According to at least one exemplary embodiment of the present disclosure Figure 4B A perspective view of the filling of the centrifuge assembly;

[0158] Figure 24J According to at least one exemplary embodiment Figure 24I A detailed schematic plan view of a portion of a collection insert channel of a centrifuge assembly;

[0159] Figure 25A is a perspective view of another softbox according to at least one exemplary embodiment of the present disclosure;

[0160] Figure 25B According to at least one exemplary embodiment of the present disclosure Figure 25A Side elevation of the soft box in ;

[0161] Figure 25C According to at least one exemplary embodiment of the present disclosure Figure 25A The front elevation of the soft box in ;

[0162] Figure 25D According to at least one exemplary embodiment of the present disclosure, Figure 25A A schematic cross-sectional view of a soft box assembly of the soft box;

[0163] Figure 25E According to at least one exemplary embodiment of the present disclosure Figure 25D A perspective view of the softbox assembly in the open state;

[0164] Figure 25F According to at least one exemplary embodiment of the present disclosure Figure 25A A partial cross-sectional view of the soft box in a first pressure state;

[0165] Figure 25G According to at least one exemplary embodiment of the present disclosure Figure 25A A partial cross-sectional view of the soft box in the second pressure state;

[0166] Figure 25H According to at least one exemplary embodiment of the present disclosure Figure 25A Exploded view of the softbox in ;

[0167] Figure 25I According to at least one exemplary embodiment of the present disclosure Figure 25A Another exploded view of the softbox in ;

[0168] Figure 25J is a diagram illustrating at least one exemplary embodiment according to the present disclosure. Figure 25A Flow chart of the manufacturing method of the soft box;

[0169] Figure 25K According to at least one exemplary embodiment of the present disclosure Figure 25A The soft box in the figure shows a partial cross-sectional view of the valve area;

[0170] Figure 25L According to at least one exemplary embodiment of the present disclosure Figure 25K Detailed cross-sectional view of the valve area in FIG;

[0171] Figure 25M is a schematic diagram of another soft box according to at least one exemplary embodiment of the present disclosure;

[0172] Figure 26A is a perspective view of a separation device in a packaged state according to at least one exemplary embodiment of the present disclosure;

[0173] Figure 26B According to at least one exemplary embodiment of the present disclosure Figure 26A An elevation view of the separation device in a packaged configuration;

[0174] Figure 26C According to at least one exemplary embodiment of the present disclosure, Figure 26A A schematic diagram of a separation component of a separation device;

[0175] Figure 26D is a schematic diagram of a blood component separation system including a properly installed component collection assembly according to at least one exemplary embodiment of the present disclosure;

[0176] Figure 26E According to at least one exemplary embodiment of the present disclosure Figure 26D A partial perspective view of a valve housing of a blood component separation system;

[0177] Figure 26F is a schematic diagram of a blood component separation system including an improperly installed component collection assembly according to at least one exemplary embodiment of the present disclosure;

[0178] Figure 26G According to at least one exemplary embodiment of the present disclosure Figure 26C Schematic diagram of the anticoagulant (AC) bag of the separation component;

[0179] Figure 26H According to at least one exemplary embodiment of the present disclosure Figure 26C Schematic diagram of a saline bag with separation components;

[0180] Figure 26I According to at least one exemplary embodiment of the present disclosure Figure 26D A perspective view of a container in a holder of a blood component separation system in FIG.

[0181] Figure 26J According to at least one exemplary embodiment of the present disclosure Figure 26I Side elevation of the container and bracket in.

[0182] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0183] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0184] The exemplary embodiments are provided to make the content of this disclosure comprehensive and to fully convey the scope of this disclosure to those skilled in the art. Many specific details are set forth, such as examples of specific components, devices, and methods, to provide a comprehensive understanding of the embodiments of this disclosure. It will be apparent to those skilled in the art that specific details need not be adopted, and that the exemplary embodiments may be embodied in a variety of different forms, and none of them should be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0185] The terms used in this disclosure are only used to describe specific exemplary embodiments and are not intended to be limiting. As used in this disclosure, unless the context clearly indicates otherwise, the singular forms "a", "a kind of" and "the" may also include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of the features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or combinations thereof. Unless specifically designated as an order of execution, the method steps, processes and operations described in this disclosure should not be interpreted as having to be performed in the specific order discussed or shown. It should also be understood that additional or alternative steps may be adopted.

[0186] When an element or layer is referred to as being “on”, “engaged to”, “connected to”, or “coupled to” another element or layer, the element or layer may be directly on, directly engaged to, directly connected to, or directly coupled to another element or layer, or there may be intervening elements or layers. In contrast, when an element is referred to as being “directly on”, “directly engaged to”, “directly connected to”, or “directly coupled to” another element or layer, there may be no intervening elements or layers. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., “between” versus “directly between”, “adjacent” versus “directly adjacent”, etc.). As used in this disclosure, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0187] Although the terms first, second, third, etc. can be used in the present disclosure to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms may only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not mean sequence or order when used in the present disclosure. Therefore, without departing from the teachings of exemplary embodiments, the first element, component, region, layer or section discussed below may be referred to as the second element, component, region, layer or section.

[0188] For ease of description, the present disclosure may use spatially relative terms such as "inside," "outside," "below," "beneath," "lower than," "above," "higher than," etc. to describe the relationship of one element or feature to one or more other elements or features as shown in the drawings. In addition to the orientation shown in the drawings, the spatially relative terms may also be intended to cover different orientations of the device in use or operation. For example, if the device in the drawings is turned over, elements described as being "below" or "beneath" other elements or features will be "above" the other elements or features. Thus, the exemplary term "below" can cover both above and below. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptive terms used in the present disclosure should be interpreted accordingly.

[0189] Various components in this disclosure are referred to as being "operably associated." As used in this disclosure, "operably associated" means components that are linked together in an operably manner, including embodiments where the components are directly linked as well as embodiments where additional components are placed between the linked components. "Operably associated" components can be "fluidically associated." "Fluidly associated" means components that are linked together so that fluid can be transported between them. "Fluidly associated" includes embodiments where additional components are provided between two fluidically associated components as well as embodiments where the components are directly connected. Fluidically associated components can include components that do not contact the fluid but do contact other components to operate the system (e.g., a peristaltic pump that pumps fluid through a flexible tube by compressing the outside of the tube).

[0190] The term "donor" as used herein may refer to anyone who provides fluid (e.g., whole blood) to a blood component separation system. A donor may also be a patient who temporarily provides fluid to a blood component separation system and returns the fluid to the patient after processing, treatment, manipulation, etc.

[0191] As used herein, the term "automatic" and its variations refer to any process or operation that is performed without substantial human input. However, even if substantial or insubstantial human input is used in the performance of a process or operation, the process or operation is still considered automatic if that input is received before the process or operation is performed. Human input is considered substantial if it affects the performance of the process or operation. Human input that consents to the performance of the process or operation is not considered "substantial."

[0192] The term "computer-readable medium" as used herein refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. Such media can take many forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, NVRAM, magnetic disks, or optical disks. Volatile media include dynamic memory, such as main memory. Common forms of computer-readable media include, for example, floppy disks, floppy disks, hard disks, magnetic tape, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tape, any other physical media with hole patterns, RAM, PROMs, EPROMs, flash EPROMs, solid-state media such as memory cards, any other memory chips or cassette memories, carrier waves as described below, or any other media from which a computer can read. Digital file attachments to emails or other self-contained information archives or archives are considered distribution media equivalent to tangible storage media. When a computer-readable medium is configured as a database, it should be understood that the database can be any type of database, such as a relational database, a hierarchical database, an object-oriented database, etc. Accordingly, the disclosure is considered to include a tangible storage medium or distribution medium storing the software implementations of the disclosure and prior art-recognized equivalents and successor media.

[0193] The term "module" as used in this disclosure refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of performing the functions associated with that element.

[0194] As used herein, the terms "determine," "calculate," and "calculate," and variations thereof, are used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0195] The present disclosure will be described more fully with reference to the accompanying drawings and in conjunction with methods and systems for separating blood components. The following examples may describe the separation of blood components from whole blood. However, these exemplary processes are for illustration only. It should be noted that the embodiments are not limited to the following description. These embodiments are intended for use in products, processes, devices, and systems for separating any complex liquid. Therefore, the present disclosure is not limited to separating blood components from whole blood.

[0196] Reference Figure 1 , shows a perspective view of an operating environment 100 of a blood component separation system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 may include the blood component separation system 200, a donor 102, and one or more connectors (e.g., a donor supply tube 104, a cartridge inlet tube 108A, an anticoagulant tube 110, etc.) that connect from the donor 102 to the blood component separation system 200 and vice versa. Figure 1As shown, donor supply tube 104 can be fluidically connected to at least one blood vessel (e.g., a vein) of donor 102 via venipuncture. For example, a cannula connected to one end of donor supply tube 104 can be inserted through the skin of donor 102 into a target site or vein. This connection can provide a venous pathway for blood to flow from donor 102 to blood component separation system 200 and / or for blood components to flow back to donor 102. In at least one exemplary embodiment, the fluid pathways and connectors can form an extracorporeal circuit of blood component separation system 200.

[0197] Blood supplied by the donor 102 can flow along the donor supply tube 104, through the tube connector 106, and along the cartridge inlet tube 108A into the softbox assembly 300. The softbox assembly 300 can include one or more fluid control pathways and valves for selectively controlling the flow of blood into and / or out of the donor 102. The blood component separation system 200 can include a supply of anticoagulant contained in an anticoagulant (AC) bag 114. The anticoagulant can be pumped through at least the anticoagulant tube 110 and the tube connector 106 to prevent blood clotting in the blood component separation system 200.

[0198] The anticoagulant may include, but is not limited to, one or more of citrate and / or unfractionated heparin. The AC bag 114 and other bags or bottles described herein may be made of, for example, but not limited to, one or more of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The volume of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102, the volumetric flow rate of the donor's blood, and the like. In one example, the volume of the AC bag 114 may be 250 to 500 milliliters, however, the volume within the AC bag 114 may be larger or smaller than this volume.

[0199] In at least one exemplary embodiment, the blood component separation system 200 can include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or conduits, such as a saline tube 116 and a plasma tube 120 (e.g., fluid transfer tubing, etc.), that connect the saline bag 118 and the plasma collection bottle 122 to an extracorporeal circuit of the blood component separation system 200. The amount of saline provided in the saline bag 118 can be 500 to 800 milliliters, however, the volume of the saline bag 118 can be greater or less than this volume. An example donation of a blood component (e.g., plasma) can be 880 milliliters. Thus, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one exemplary embodiment, the plasma collection bottle 122 can include connection points, (e.g., such as Figure 2A As shown, when the plasma collection bottle 122 is placed in the plasma collection bracket 232C, the connection point is provided at, adjacent to, or physically close to the substantially bottom-most portion of the plasma collection bottle 122. The connection point may include one or more connectors configured to interconnect with the plasma tube 120 to receive and / or transfer plasma. The provision of the connection point at the bottom of the plasma collection bottle 122 allows the plasma contained in the plasma collection bottle 122 to be removed from the plasma tube 120 through the tubing, as described herein, without trapping air bubbles, etc. In at least one exemplary embodiment, the plasma collection bottle 122 can be configured as a flexible bag, a rigid container, and / or other container, and thus, the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0200] Figure 2A Shown Figure 1. The blood component separation system 200 can provide a continuous whole blood separation process. In at least one exemplary embodiment, whole blood can be drawn from a donor 102 and provided substantially continuously to a blood component separation device of the blood component separation system 200, where the blood can be separated into various components, and at least one of the blood components can be collected from the blood component separation system 200. In at least one exemplary embodiment, one or more of the separated blood components can be collected for subsequent use or returned to the donor 102. Blood can be drawn from the donor 102 and directed into a centrifuge of the blood component separation system 200 through an opening 220 in an access plate 224 of the blood component separation system 200. In at least one exemplary embodiment, the donor feed tube 104, the cassette inlet tube 108A, the inlet tube 108B (also referred to herein as the circuit inlet tube 108B), the outlet tube 112 (also referred to herein as the circuit outlet tube 112), the saline tube 116, and the plasma tube 120 used in the extracorporeal circuit may collectively define a closed, sterile, and disposable system or blood component collection device, which may be further described below.

[0201] Examples of blood component separation systems, plasma separation systems, and other separation systems (e.g., blood component separation system 200) that can be used with embodiments of the present disclosure include, but are not limited to, SPECTRA Blood component separation system, Spectral Blood Component Separation System and TRIMA Automated blood collection systems, all manufactured by Terumo BCT in Lakewood, Colorado.

[0202] The operation of the various pumps, valves, and blood component separation devices or centrifuges can be controlled by one or more processors included in the blood component separation system 200, and can advantageously include multiple embedded computer processors as part of a computer system. The computer system may also include components that allow a user to interact with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.); communication / networking devices (e.g., wired devices such as modems / network cards, or wireless devices such as Wi-Fi); input devices such as one or more keyboards, one or more touch screens, one or more cameras, and / or one or more microphones; and one or more output devices such as one or more displays and one or more audio systems. In at least one exemplary embodiment, to assist an operator of the blood component separation system 200 in various aspects of operation, the blood component separation device or centrifuge may include a graphical user interface having a display that includes an interactive touch screen.

[0203] The blood component separation system 200 can include a housing 204 and / or structural frame, a cover 210, an access panel 224 disposed at the front 202 and / or rear 206 of the blood component separation system 200, and one or more supports 232A to 232C, the supports 232A to 232C comprising hooks, brackets, brackets, arms, protrusions, plates, and / or other support structures for securing, supporting, and / or otherwise supporting a container or AC bag 114, a saline bag 118, or a plasma collection bottle 122. In at least one exemplary embodiment, features of the blood component separation system 200 can be described with reference to a coordinate system 103 and / or one or more axes therein. The housing 204 can include a machine frame (e.g., made of welded, bolted, and / or connected structural elements, extruded materials, beams, etc.), to which one or more panels (e.g., the cover 210, doors, subassemblies, and / or assemblies) are attached. In at least one exemplary embodiment, at least one panel of the blood component separation system 200 can include a mounting surface for the soft box assembly 300, one or more pumps (such as an aspiration 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 controls, etc.).

[0204] The access panel 224 may include one or more handles, locks, and pivot or articulated shafts 226 (e.g., door hinges, piano hinges, continuous hinges, clean room hinges, etc.). In any event, the access panel 224 may be selectively opened to provide access to the interior of the blood component separation system 200, and more specifically, to the blood separation components or centrifuge. In at least one exemplary embodiment, the access panel 224 may provide access for loading and / or unloading a centrifuge in a blood component collection device, with one or more components. Details of the centrifuge will be described below with reference to at least Figures 4A to 4L Describe in more detail.

[0205] The interior of the blood component separation system 200 can be divided into at least a centrifuge portion and a control portion. For example, the centrifuge portion can include a cavity configured to accommodate a centrifuge, a rotating motor, and related hardware. This area can be physically separated from the control portion by one or more walls of the cavity. In at least one exemplary embodiment, access to the control portion (e.g., configured to accommodate or otherwise contain a motor controller, a CPU or one or more processors, electronic equipment, wiring, etc.) can be provided by a firmly fixed plate of the housing 204 and / or a plate separated from the access plate 224.

[0206] In at least one exemplary embodiment, the blood component separation system 200 may include a plurality of pumps, such as an aspiration pump 208, a return pump 212, or an AC pump 216, configured to control the flow of fluid (e.g., blood and / or blood components, anticoagulant, saline, etc.) through the blood component separation system 200. For example, the blood component separation system 200 may include an aspiration pump 208 that controls the flow of blood to and / or from the donor 102 into a centrifuge of the blood component separation system 200. The aspiration pump 208 may be coupled to a portion of an inlet tube 108B disposed between the soft cartridge assembly 300 and the centrifuge of the blood component separation system 200. In at least one exemplary embodiment, the blood component separation system 200 may include a return pump 212 configured to control the flow of separated blood components (e.g., plasma, etc.) from the centrifuge to the plasma collection bottle 122, and / or to control the flow of separated blood components (e.g., plasma, etc.) from the plasma collection bottle 122 to the centrifuge. Additionally or alternatively, the return pump 212 may control the flow of saline (e.g., supplied from the saline bag 118) throughout the blood component collection device and / or the blood component separation system 200. The AC pump 216 may be coupled to a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant in the blood component collection device of the blood component separation system 200. Figure 2AAs shown, the aspiration pump 208 , the return pump 212 , and the AC pump 216 may be at least partially disposed on top of the cover 210 of the blood component separation system 200 .

[0207] Figure 2B and Figure 2C Various perspective views of the aspiration pump 208, return pump 212, or AC pump 216 of the blood component separation system 200 are shown in accordance with at least one exemplary embodiment of the present disclosure. Figure 2B and Figure 2C An aspiration pump 208 is shown and described, but it should be understood that the other pump components of the blood component separation system 200 (i.e., the return pump 212 and the AC pump 216) may be different and operate differently in some details; however, in many cases, the return pump 212 and / or the AC pump 216 may be or may include a structure that is substantially similar (if not identical) to the aspiration pump 208.

[0208] The suction pump 208 can include a pump cover 236 or housing configured to at least partially enclose the moving elements of the suction pump 208. In at least one exemplary embodiment, the pump cover 236 can include a hinged pipe guard door subassembly or pipe guard 240 configured to open and close about a pipe guard pivot axis 242. In at least one exemplary embodiment, the pipe guard 240 can be attached to the pump cover 236 by one or more fasteners disposed along the pipe guard pivot axis 242. Figure 2B and Figure 2C As shown, blood provided by donor 102 can be conveyed or aspirated into the centrifuge by aspiration pump 208 along a first aspiration or centrifugal direction 250A. Additionally or alternatively, blood or other fluids can be conveyed or aspirated by aspiration pump 208 toward donor 102 along a donor direction 250B opposite to centrifugal direction 250A.

[0209] In at least one exemplary embodiment, the suction pump 208 and / or the return pump 212 and the AC pump 216 can be tubing pumps, peristaltic pumps, diaphragm pumps, and / or other pumps configured to manipulate the flow of a fluid (e.g., blood, blood components, anticoagulant, saline, etc.) in at least a portion of the tubing. For example, the suction pump 208, the return pump 212, or the AC pump 216 can include a motor operably interconnected with the rotating tubing contact assembly. In operation, tubing (e.g., the inlet tubing 108B, the outlet tubing 112, the anticoagulant tubing 110, etc.) can be inserted into the guide tubing guide 244, the tubing pressure block 248, and the end tubing guide 252 adjacent to the rotating tubing contact head. In at least one exemplary embodiment, the tubing pressure block 248 can be moved in a direction away from the rotating tubing contact head of the suction pump 208, the return pump 212, or the AC pump 216 to provide a loading gap region, and vice versa. The rotating pipe contact head may include a plurality of rotating pressure rollers 268 configured to rotate about a corresponding pressure roller rotation axis 264. Each rotating pressure roller 268 may be disposed between a first rotating pump plate 272A and a second rotating pump plate 272B, wherein the first rotating pump plate 272A and the second rotating pump plate 272B are configured to rotate about the pump rotation axis 260. In at least one exemplary embodiment, the rotating pressure rollers 268 may be disposed around the first rotating pump plate 272A and the second rotating pump plate 272B.

[0210] One or more of the suction pump 208, the return pump 212, or the AC pump 216 may include Model UX-74130 Peristaltic Pump and MEC-O-MATIC series pumps, or similarly operating therewith, all of which are manufactured by Pulsafeeder, Inc. of Punta Gorda, Florida, but the suction pump 208, return pump 212, or AC pump 216 are not limited thereto. Other examples of the suction pump 208, return pump 212, or AC pump 216 may include, but are not limited to, the INTEGRA DOSE IT laboratory peristaltic pumps manufactured by INTEGRABiosciences AG of Switzerland, and the WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pumps manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0211] Once tubing is loaded into the inlet tubing guide 244, tubing pressure block 248, and / or end tubing guide 252, at least some of the rotating pressure rollers 268 can be brought into engagement, contact, or otherwise compressed with the tubing disposed between the rotating tubing contact head and the tubing pressure block 248. As the first and second rotating pump plates 272A, 272B rotate about the pump rotation axis 260, the rotating pressure rollers 268 can compress a portion of the tubing between the suction pump 208, return pump 212, or AC pump 216 and the tubing pressure block 248, thereby causing the fluid within that portion of the tubing to positively move in a particular direction (e.g., the centrifugal direction 250A or the donor direction 250B) as the rotating pressure rollers 268 move. For example, as the first and second rotating pump plates 272A, 272B rotate counterclockwise about the pump rotation axis 260, the rotation of the rotating pressure roller 268 compresses the tubing between the rotating pressure roller 268 and the tubing pressure block 248, thereby moving or pumping fluid in the centrifugal direction 250A. As another example, as the first and second rotating pump plates 272A, 272B rotate clockwise about the pump rotation axis 260, the rotation of the rotating pressure roller 268 compresses the tubing between the rotating pressure roller 268 and the tubing pressure block 248, thereby moving or pumping fluid in the donor direction 250B. When not actively pumping, the pump 208 can maintain a state in which at least one rotating pressure roller 268 continues to block the inlet tube 108B (normally closed, or NC), or a state in which none of the rotating pressure rollers 268 blocks the inlet tube 108B (normally open, or not). Thus, depending on the state at rest, the suction pump 208 can also act as a "valve" to prevent or allow fluid movement. The return pump 212 and / or the AC pump 216 may also have this capability.

[0212] The tube guard 240 and pump cover 236 can be used to protect an operator (e.g., a phlebotomist, apheresis technician, etc.) and / or the donor 102 from accidental contact with one or more moving parts of the aspiration pump 208, the return pump 212, or the AC pump 216. In at least one exemplary embodiment, the tube guard 240 can be maintained in a closed position by one or more guard closure features 254 disposed in or associated with the operation of the tube guard 240, the guide tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In some cases, these guard closure features 254 can be magnets incorporated into the tube guard 240, the guide tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In at least one exemplary embodiment, when the tube guard 240 is open, the aspiration pump 208, the return pump 212, or the AC pump 216 can be stopped or prevented from moving / operating. In at least one exemplary embodiment, a door closure sensor may be included in the guard closure feature 254 , the lead duct guide 244 , the end duct guide 252 , and / or the duct pressure block 248 .

[0213] One or more fluid control valves may be used to control the path or flow direction of fluids conveyed through the tubing of the blood component separation system 200. In at least one exemplary embodiment, the blood component separation system 200 may include a plasma and saline valve control system, such as a 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 may be configured to control the flow of fluids through the tubing of the blood component separation system 200. Figure 2D Detailed perspective view of the .

[0214] like Figure 2D As shown, the outlet tube 112 can pass through the reflux pump 212 and interconnect with the saline and plasma tubing y-connector 280. The saline and plasma tubing y-connector 280 can allow the outlet tube 112 to be connected to the saline line 116 and the plasma line 120. The fluid valve control system 228 can include an air detection sensor 284 disposed at the first end of the saline and plasma valve housing 276 and surrounding a portion of the outlet tube 112. The air detection sensor 284 can be any optical, ultrasonic, or other type of sensor that can detect the presence of fluid or air in the outlet tube 112 and provide the signal to the controller of the blood component separation system 200. The type of air detection sensor 284 can include, for example, the SONOCHECK ABD05 manufactured by SONOTEC USA, Inc. or another similar sensor.

[0215] The saline and plasma valve housing 276 can include a plurality of receiving features (e.g., grooves, channels, receiving slots, etc.) that receive a portion of the outlet tube 112, the saline tube 116, the plasma tube 120, and / or the saline and plasma tube y-connector 280. Upon detecting air in the outlet tube 112, the fluid valve control system 228 can selectively actuate one or more fluid control valves, such as the plasma flow control valve 286 and the saline flow control valve 288. In at least one exemplary embodiment, the detection of air via the air detection sensor 284 can be used to indicate an operating step and / or trigger a step in a control method as described herein.

[0216] The plasma flow control valve 286 and / or the saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamping valves, in-line valves, and / or other actuatable valves configured to selectively alter (e.g., block) the fluid pathway associated with a particular portion of the outlet tube 112, the saline tube 116, or the plasma tube 120. Figure 2D As shown, the plasma flow control valve 286 can be configured to clamp a portion of the plasma tubing 120 at least partially contained within the receiving feature of the saline and plasma valve housing 276. The saline flow control valve 288 can be configured to clamp a portion of the saline tubing 116 at least partially contained within the receiving feature of the saline and plasma valve housing 276. In any event, the plasma flow control valve 286 and the saline flow control valve 288 can include actuatable, extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to clamp a portion of the tubing contained within the saline and plasma valve housing 276. While the plasma flow control valve 286 and the saline flow control valve 288 can fully clamp the tubing (e.g., fully restrict fluid flow through the tubing), it should be understood that the plasma flow control valve 286 and the saline flow control valve 288 can be partially actuated to a position that partially restricts fluid flow through a portion of the tubing.

[0217] It should be understood that the aspiration pump 208, the return pump 212, and the AC pump 216 include additional components, which are described, for example, in U.S. application Ser. No. 18 / 116,527, filed on March 2, 2023, entitled "Fluid Control and Bypass Features of a Blood Component Separation System" (Attorney Docket No. 18955-000029-US), the entire contents of which are incorporated herein by reference.

[0218] First example of a softbox with integrated features

[0219] Figure 3A is a partial perspective view of a softbox assembly according to at least one example embodiment.

[0220] In at least one exemplary embodiment, Figure 3A, which shows a detailed perspective view of a disposable soft cartridge assembly 300 according to an embodiment of the present disclosure. The soft cartridge assembly 300 can include a base plate 302 and a cartridge access door 304 attached to the base plate 302 by at least one hinge 306 and / or a cartridge access door latch 308. In at least one exemplary embodiment, the cartridge access door 304 can be unlocked by actuating the cartridge access door latch 308 and pivoting the cartridge access door 304 about a cartridge access door hinge axis 310.

[0221] In at least one exemplary embodiment, the soft cartridge assembly 300 can be configured with one or more soft cartridge receiving features 312 for at least partially receiving and / or positioning a soft cartridge 314 within the soft cartridge receiving features 312. The soft cartridge 314 can be part of a blood component collection device as described herein. For example, the soft cartridge 314 can be positioned between the cartridge inlet tube 108A and the circuit inlet tube 108B of the extracorporeal circuit (e.g., Figure 5A In at least one exemplary embodiment, the softbox 314 may provide one or more features for controlling the removal of blood and / or blood components from the donor 102 (e.g., Figure 1 A) to the blood component separation system 200 (as shown in Figure 1 A), and / or vice versa.

[0222] In at least one exemplary embodiment, the soft cartridge assembly 300 includes an air detection sensor 316, a fluid sensor 318, and one or more fluid control valves 320A, 320B, 320C configured to control the path or flow direction of fluid through the soft cartridge 314. In at least one exemplary embodiment, these components can be independently embedded in the cartridge access door 304, the base plate 302, and / or a portion of the housing 204 of the blood component separation system 200 (e.g., Figure 1 A). Similar to the combination Figures 2B to 2C In addition to the guard closure features 254 described above, the softbox assembly 300 may include one or more door closure features 328. The door closure features 328 may include, but are not limited to, magnetic snaps, protrusions, tabs and slots, and / or other connectors. In at least one exemplary embodiment, the door closure features 328 may include a pressure contact surface configured to retain or at least partially position the softbox 314 within the softbox assembly 300.

[0223] In at least one exemplary embodiment, valves 320A, 320B, and 320C may include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamping valves, in-line valves, and / or other actuatable valves configured to selectively change, for example, block, a fluid passageway (e.g., cross-sectional area, etc.) associated with a particular portion of the softbox 314.

[0224] In at least one exemplary embodiment, the soft cartridge assembly 300 can include a first fluid control valve 320A configured to clamp a portion of the soft cartridge 314 adjacent to the cartridge inlet tube 108A. The second fluid control valve 320B can be configured to clamp a portion of the soft cartridge 314 adjacent to the circuit inlet tube 108B. The suction fluid control valve 320C can be configured to clamp a portion of the soft cartridge 314 along a branch tube extending from a point adjacent to the cartridge inlet tube 108A to a point adjacent to the circuit inlet tube 108B. In at least one exemplary embodiment, each of the valves 320A, 320B, and 320C can include an actuatable, extendable finger that moves from a retracted or partially retracted position to an extended or partially extended position to clamp a portion of the soft cartridge 314 contained within the soft cartridge assembly 300. Although valves 320A, 320B, and 320C can completely clamp the flow path in the soft box 314 (e.g., completely restrict fluid flow through the soft box 314), it should be understood that valves 320A, 320B, and 320C can be partially actuated to a position that partially restricts fluid flow through a portion of the soft box 314.

[0225] In at least one exemplary embodiment, sensor 316 and sensor 318 can be one or more of ultrasonic detectors, pressure sensors, magnetic position sensors, etc. In some cases, fluid sensor 318 can be configured to determine whether there is fluid in soft box 314 based on the position of magnet relative to soft box 314 partial area. For example, when the partial area of ​​soft box 314 is filled with fluid, the magnet can be set at a first position away from soft box 314 surfaces. On the other hand, when the partial area of ​​soft box 314 is filled with air, the force from the magnet can compress the partial area of ​​soft box 314 to a second position closer to soft box 314 surfaces than the first position. In at least one exemplary embodiment, the detection of air or fluid via air detection sensor 316 and fluid sensor 318, respectively, can be used to indicate an operating step and / or triggering step in the control method as described herein.

[0226] Figure 3B According to at least one exemplary embodiment Figure 3A A perspective view of the softbox in the softbox assembly. Figure 3C According to at least one exemplary embodiment Figure 3A The line 3C-3C in the Figure 3B A cross-sectional view of the softbox in Figure 1. Figure 3D According to at least one exemplary embodiment Figure 3A The line in 3D-3D intercept Figure 3A A cross-sectional view of the softbox in Figure 1.

[0227] In at least one exemplary embodiment, the soft box 314 can be part of a blood component collection device. For example, the soft box 314 can be a disposable component used in the blood separation method described herein. In at least one exemplary embodiment, the soft box 314 can be made of a substantially compliant and / or flexible material. The compliant material can be chemically inert and / or able to withstand sterilization and cleaning operations, various temperatures and / or treatments. The soft box 314 can be formed from a thermoplastic material. In at least one exemplary embodiment, the soft box 314 includes PVC, plasticized PVC, polyethylene, EVA, rubber, silicone, thermoplastic elastomer, copolymers thereof, and / or combinations thereof. In at least one exemplary embodiment, the soft box 314 is molded, rotationally molded, cast, injection molded, or otherwise formed from one or more of the above materials.

[0228] In at least one exemplary embodiment, the soft box 314 may include and / or define a first box port 340A (e.g., Figures 3B to 3C As shown), the second box port 340B (as Figures 3B to 3C ), and a direct flow lumen 350 extending between the first cartridge port 340A and the second cartridge port 340B (as shown Figure 3C In at least one exemplary embodiment, the first box port 340A and / or the second box port 340B can be configured to receive one or more tubes of the blood component collection device and / or be coupled to one or more tube fluids of the blood component collection device. In at least one exemplary embodiment, the first box port 340A can be coupled to the box inlet pipe 108A, and the second box port 340B can be coupled to the circuit inlet pipe 108B. These couplings can be airtight and / or liquid-tight. In at least one exemplary embodiment, the first box port 340A and / or the second box port 340B can be a hole arranged in the soft box 314, or can include a hole arranged in the soft box 314, which is configured to elastically stretch around the end of a tube (e.g., box inlet pipe 108A, circuit inlet pipe 108B, etc.).

[0229] In at least one exemplary embodiment, the donor 102 (e.g. Figure 1 A) can be directed along one or more fluid pathways disposed within the soft cartridge 314. In one embodiment, blood can be directed from the first cartridge port 340A to the second cartridge port 340B along a direct flow lumen 350. In some embodiments, the flow pathway can direct blood through a first chamber or drip chamber 354 of the soft cartridge 314. In some embodiments, blood and / or other fluids returned to the donor 102 can be directed along the direct flow lumen 350 from the second cartridge port 340B to the first cartridge port 340A.

[0230] In at least one exemplary embodiment, the softbox 314 includes a first bypass branch 358 (e.g., Figure 3B 、 Figure 3D As shown in FIG. 1 , the first bypass branch 358 has a bypass flow cavity 360 (as shown in FIG. Figure 3D 340A), the bypass lumen 360 is fluidically connected to the portion of the direct flow lumen 350 adjacent to the first cartridge port 340A, or is a portion of the first cartridge port 340A. In some embodiments, the bypass lumen 360 may extend from a point of the direct flow lumen 350 adjacent to the first cartridge port 340A, along the first bypass branch 358, through the second chamber or fluid pressure ring 362 (e.g., Figure 3B 、 Figure 3D As shown) to the second bypass branch 364 (as shown Figure 3B 、 Figure 3D 354 ) and then reconnected to the direct flow lumen 350 at a point adjacent to the second cartridge port 340B, or as part of the second cartridge port 340B. As the name implies, the bypass lumen 364 provides a flow path within the soft cartridge 314 that bypasses the drip chamber 354.

[0231] In at least one exemplary embodiment, controlling the flow path within the soft cartridge 314 or directing the fluid within the soft cartridge 314 may include actuating the fluid control valves 320A, 320B, and 320C (e.g., Figure 3A ), to block and / or open the various compliance regions 370A, 370B, and 370C (as shown in FIG. Figure 3B) interact with each other. The first compliance region 370A provides a pinch valve region at a point along the direct current lumen 350 between the first cartridge port 340A and the drip chamber 354 near the first cartridge end 372 of the soft cartridge 314. When the first fluid control valve 320A is actuated, the valve 320A can pinch the direct current lumen 350 at this first compliance region 370A to close it, thereby limiting or completely preventing fluid flow at that point in the soft cartridge 314. The second compliance region 370B provides a pinch valve region at a point along the direct current lumen 370 between the second cartridge port 340B and the drip chamber 354 near the second cartridge end 374 (e.g., opposite the first cartridge end 372). When the second fluid control valve 320B is actuated, the valve 320B can pinch the direct current lumen 350 at this second compliance region 370B to close it, thereby limiting or completely preventing fluid flow at that point in the soft cartridge 314. It will be appreciated that the third compliance region 370C disposed adjacent the fluid pressure ring 362 along the first bypass branch 358 can provide a pinch valve region at a point along the bypass lumen 360. When the aspiration fluid control valve 320C is actuated, the valve 320C can pinch the bypass lumen 360 closed at this third compliance region 370C, thereby limiting or completely preventing fluid flow through the bypass lumen 360.

[0232] In at least one exemplary embodiment, Figure 3C As shown in the elevational cross-sectional view taken through a plane passing through the direct flow lumen 350 and the drip chamber 354, the direct flow lumen 350 extends from the first cartridge port 340A through the inner luminal volume 376 of the drip chamber 354 to the second cartridge port 340B. The direct flow lumen 350 can be formed as a fluid passage extending within the first tubing segment 378, the inner luminal volume 376, and the second tubing segment 379 of the soft cartridge 314.

[0233] In at least one exemplary embodiment, the bypass path of the soft box 314 can include a fluid pressure ring 362 through which fluid can flow from the first bypass branch 358 to the second bypass branch 364, and / or vice versa. In at least one exemplary embodiment, the pressure diaphragm 380 (e.g., Figure 3D As shown in FIG. 3 , a region can be formed of the material of the soft box 314, which is located within or adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and the pressure diaphragm 380 are formed in a manner similar to the embodiment of FIG. Figure 3D , which is taken through a plane passing through the fluid pressure ring 362 and a portion of the first bypass branch 358 and the second bypass branch 364.

[0234] In at least one exemplary 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 lumen 360 contain a certain amount of fluid, air, and / or a combination of fluid and air. As described above, when the fluid pressure ring 362 is partially filled with fluid, the fluid can provide a greater resistance to movement than when the fluid pressure ring 362 is completely filled with air. This resistance difference can be measured by the fluid sensor 316 to determine the amount and / or type of fluid (e.g., air, blood, etc.) in the bypass lumen 360 and / or the fluid pressure ring 362.

[0235] Exemplary Centrifuge Components

[0236] Figure 4A is a perspective view of an exemplary centrifuge assembly 400 for use in a blood component separation system 200 according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 can be disposed in an interior space of the blood component separation system 200. The interior space can be at least partially surrounded by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the interior space and the centrifuge assembly 400 can be provided by an access panel 224 disposed at the front 202 of the blood component separation system 200. For example, Figure 4A , access panel 224 is shown opened and in an open position along hinge axis 226. Hinge axis 226 may correspond to a door hinge, a continuous hinge, a clean room hinge, and / or other panel hinge.

[0237] The centrifuge assembly 400 can be operably mounted within the blood component separation system 200 such that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the blood component separation system 200. Figure 2A The centrifuge assembly 400 can be loaded with a blood component collection device (e.g., a blood component collection device). Figures 5A to 5H The fixed circuit connector 402 holds the inlet tube 108B and the outlet tube 112 in a fixed position and prevents the tubes 108B and 112 from twisting outside the blood component separation system 200. In at least one exemplary embodiment, the blood component collection circuit 520 can be interconnected with the fixed circuit connector 402 via one or more keying features or positive positioning features.

[0238] For illustrative purposes, Figures 4B to 4CThe centrifuge assembly 400 is shown separated from the blood component separation system 200. The centrifuge assembly 400 may include a centrifuge split housing 404 including a lower housing 404A pivotally connected to an upper housing 404B. The upper housing 404B may be opened to provide access to a blood component collection bag (e.g., Figures 5A to 5H ) is loaded into a channel in the centrifuge assembly 400. In at least one exemplary embodiment, the upper housing 404B can pivot about a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, shoulder bolt).

[0239] The different halves of the centrifuge split housing 404 (e.g., the lower housing 404A and the upper housing 404B) can be configured to lock and / or unlock together. Unlocking the upper housing 404B from the lower housing 404A can provide access to the interior of the centrifuge assembly 400. This selective locking can be achieved by rotating the upper housing 404B relative to the lower housing 404A about the centrifuge rotation axis 430. Although Figures 4B to 4C 4B is shown in an unlocked state, but it should be understood that the upper housing 404B can be rotated about the centrifuge rotation axis 430 (e.g., in a counterclockwise direction) to engage one or more locking tabs 428 or elements of the upper housing 404B with locking slots 432 provided in the lower housing 404A (e.g., as shown in FIG. Figure 4C ). When in the unlocked position, the upper housing 404B can be opened or pivoted about the split housing pivot axis 406 to load the blood component collection circuit 520 and / or the blood component collection bladder 536 into the centrifuge assembly 400. When in the locked position, the upper housing 404B is rotationally locked relative to the lower housing 404A, and the two halves of the centrifuge split housing 404 can rotate together, locked synchronously, during centrifugation or blood separation operations.

[0240] The centrifuge assembly 400 can include at least one clockwise rotation stop 408A, a counterclockwise rotation stop 408B, an upper housing clockwise rotation indicia 410A, and / or an upper housing counterclockwise rotation indicia 410B. In at least one exemplary embodiment, the rotation stops 408A, 408B can be rotationally fixed relative to the centrifuge rotation axis 430 of the lower housing 404A. The rotation indicia 410A, 410B can be attached to or formed in the upper housing 404B and configured to contact the corresponding rotation stops 408A, 408B to prevent the upper housing 404B from over-rotating relative to the lower housing 404A when the two halves of the centrifuge split housing 404 are locked and / or unlocked together. For example, when the upper housing 404B is rotated in a clockwise or unlocked direction about the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A can contact the clockwise rotation stop 408A, thereby preventing further rotation in the clockwise direction. Additionally or alternatively, when the upper housing 404B is rotated in a counterclockwise or locked direction about the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation flag 410B can contact the counterclockwise rotation stop 408B, thereby preventing further rotation in the counterclockwise direction. In at least one exemplary embodiment, the centrifuge split housing 404 can include one or more locking elements that are configured to maintain the halves of the centrifuge split housing 404 in a locked state when the locking elements are engaged.

[0241] In at least one exemplary embodiment, the centrifuge split housing 404 can include a pull ring 412 attached to a portion of the upper housing 404B to enable the upper housing 404B to pivot relative to the lower housing 404A about the split housing pivot axis 406. The pull ring 412 can provide a hole through which a user can insert a finger and apply a pulling force to the rotationally unlocked upper housing 404B.

[0242] The centrifuge assembly 400 may include a rotor and motor assembly 414 that is controlled and / or powered by a cable 420 of electrical interconnects. The cable 420 may include a connector that is attached to a controller, a processor, and / or a power supply. The cable 420 may transmit power and / or data signals between the rotor and motor assembly 414 and one or more controllers / processors of the blood component separation system 200. The rotor and motor assembly 414 may be configured as a motor and / or a portion of a motor that rotates the entire centrifuge assembly 400 relative to the blood component separation system 200 (e.g., relative to a portion of the housing 204 and / or the base of the blood component separation system 200). In other words, the rotor and motor assembly 414 may include one or more components that rotate the centrifuge assembly 400 (e.g., the two halves of the centrifuge split housing 404 together) within the blood component separation system 200.

[0243] As described herein, the centrifuge assembly 400 may include one or more features to guide, contain, and / or position components of the blood component collection device relative to the centrifuge split housing 404. For example, Figure 4B , the blood component collection circuit 520 is shown captured in an operative position of a circuit rotational position guide 424 including a circuit capture arm 416. The circuit rotational position guide 424 may include a plurality of bearings 417 and / or bearing surfaces arranged to at least partially support the blood component collection circuit 520 in the operative position. In the operative position, the blood component collection circuit 520 may be twisted along its length within the support provided by the bearings 417 of the circuit rotational position guide 424. For example, one end of the blood component collection circuit 520 may be fixedly attached to the fixed circuit connector 402 of the blood component separation system 200, while the other end of the blood component collection circuit 520 may be attached to a filler 460 (e.g., an internal rotating component of the centrifuge assembly 400). When the centrifuge assembly 400 rotates during a centrifugation operation, twisting of the blood component collection circuit 520 between the connection at the stationary circuit connection 402 and the filler 460 can cause the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In at least one exemplary embodiment, when the centrifuge assembly 400 rotates in the blood component separation system 200, the low inertia of the filler 460 coupled with the twisting of the blood component collection circuit 520 can cause the filler 460 to rotate in the same rotational direction at twice the angular velocity of the centrifuge split housing 404. In this example, when the centrifuge split housing 404 rotates counterclockwise about the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 can rotate counterclockwise within the centrifuge split housing 404 at a second angular velocity 2ω (e.g., substantially twice the first angular velocity, etc.).

[0244] The centrifuge assembly 400 may include one or more balancing features, elements, and / or structures disposed about the centrifuge axis of rotation 430 of the centrifuge assembly 400. These balancing features may provide an axially balanced centrifuge assembly 400 such that when rotating about the centrifuge axis of rotation 430, the centrifuge assembly 400 may not substantially cause vibrations to the blood component separation system 200. In at least one exemplary embodiment, a centrifuge balancing weight 418 may be attached to a portion of the centrifuge housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). The centrifuge balancing weight 418 may be custom-calibrated for the centrifuge assembly 400 and may be selectively attached to and removed from the centrifuge assembly 400. The calibration of the centrifuge balancing weight 418 may be calculated and / or empirically determined to provide a fully balanced centrifuge assembly 400, particularly when the centrifuge assembly 400 is loaded with one or more components of a blood component collection device.

[0245] Figure 4CA rear perspective view of a centrifuge assembly 400 according to at least one exemplary embodiment of the present disclosure is shown. A portion of the filler 460 is visible through an aperture in the upper housing 404B. The blood component collection circuit 520 is shown in an initial circuit loading position 520A, in which a first end is interconnected with the filler 460 and a second end is fixedly attached to the fixed circuit connector 402 (not shown). The blood component collection circuit 520 is shown passing through the circuit in the centrifuge split housing 404 and into the gap 436. When the blood component collection circuit 520 is loaded in the circuit loading position 520A, a portion of the blood component collection circuit 520 can be partially contained, secured, and / or supported by a circuit containment bracket 426. The circuit containment bracket 426 can include one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc., and / or combinations thereof) or bearing surfaces arranged to at least partially support the blood component collection circuit 520 when the blood component collection circuit 520 is twisted relative to the centrifuge assembly 400. In at least one exemplary embodiment, the blood component collection circuit 520 can rotate about an axis extending along the length of the flexible circuit 524 (e.g., in an installed or assembled condition and / or state, etc.), which allows the flexible circuit 524 to perform relative rotational motion relative to the circuit rotation position guide 424. For example, the circuit does not "kink" but actually rotates or rolls between one or more bearings 417 relative to the circuit rotation position guide 424 (e.g., a support structure). Such rotation or twisting, without constraining or kinking the flexible circuit 524, may be referred to herein as torsion. Torsion allows the flexible circuit 524 to transmit rotational forces to the filler 460 without significantly reducing the inner diameter of the lumen of the flexible circuit 524. In some cases, the inner diameter of the lumen of the flexible circuit 524 is not reduced.

[0246] As described above, when the upper housing 404B is Figures 4B to 4C When the illustrated rotationally unlocked position is rotated to the rotationally locked position, the locking tab 428 of the upper housing 404B can engage with the locking groove 432 of the lower housing 404A. Additionally or alternatively, when moved to the rotationally locked position, the circuit receiving bracket 426 can be rotated along the circuit engaging position 520B with the blood component collection circuit 520 and the upper housing 404B to a position aligned with the circuit rotation position guide 424. In at least one exemplary embodiment, when the upper housing 404B and the blood component collection circuit 520 are rotated to the circuit engaging position 520B, the circuit capture arm 416 can guide the blood component collection circuit 520 into the bearing 417 and / or bearing surface of the circuit rotation position guide 424. This will be discussed below in conjunction with Figures 6A to 7B The loading process of the blood component collection circuit 520 is described in detail.

[0247] Figures 4D to 4F Various schematic cross-sectional views taken through the center of the centrifuge assembly 400 are shown (e.g., bisecting the centrifuge assembly 400 by the centrifuge axis of rotation 430, etc.). As described above, the centrifuge assembly 400 can include a lower housing 404A pivotally attached to an upper housing 404B via a split housing pivot shaft 406 or hinge. The upper housing 404B can be attached to an upper housing adapter 440 that is rotatably interconnected with an upper housing bushing block 442 attached to a pull ring 412. In at least one exemplary embodiment, a bearing 417, bushing, or bearing surface can be disposed between the upper housing adapter 440 and the upper housing bushing block 442 to allow the upper housing 404B to rotate along the centrifuge axis of rotation 430 from a locked position to an unlocked position, and vice versa. The pull ring 412 can be rotationally fixed relative to the lower housing 404A about the centrifuge axis of rotation 430. In at least one exemplary embodiment, upper housing adapter 440 and upper housing 404B may be formed as a unitary structure.

[0248] The filler 460 can be fixedly attached to a filler spindle 434 that is configured to rotate relative to the upper housing 404B about the centrifuge rotation axis 430. In at least one exemplary embodiment, the filler spindle 434 can be formed from a portion of the filler 460. In any case, one or more spindle support bearings 444 can be disposed between the filler spindle 434 and the upper housing adapter 440, thereby allowing the filler 460 to rotate about the centrifuge rotation axis 430 within the centrifuge split housing 404 and the centrifuge assembly 400. In at least one exemplary embodiment, the filler spindle 434 can be retained in an operative position by at least one retaining nut 438. The filler 460 and the filler spindle 434 can rotate together relative to the centrifuge split housing 404.

[0249] Figure 4D A schematic cross-sectional view of the centrifuge assembly 400 is shown in a closed state (e.g., prior to loading the blood component collection circuit 520). Upon unlocking the upper housing 404B relative to the lower housing 404A, an operator can pull the pull ring 412 to pivot the entire upper housing 404B and filler 460 about the split housing pivot axis 406. In at least one exemplary embodiment, the upper housing 404B and filler 460 can be partially opened by pivoting the components about the split housing pivot axis 406 in an opening direction 446. For example, Figure 4E4. As shown, in which centrifuge assembly 400 is shown in a partially open position, upper housing 404B and filler 460 are rotated offset from lower housing rotation axis 430A. In this position, filler 460 is allowed to rotate about filler rotation axis 430B. When lower housing 404A and upper housing 404B are in a closed position, lower housing rotation axis 430A and filler rotation axis 430B are aligned (coincident or substantially coincident) to form centrifuge rotation axis 430.

[0250] Continuing to rotate the upper housing 404B and filler 460 in the opening direction 446 about the y-axis of the split housing pivot axis 406 (e.g., by continuing to pull the pull ring 412) may cause the upper housing 404B and filler 460 to move from Figure 4D The closed position shown is pivoted approximately 180 degrees. Figure 4F 4B and the like. As shown, the centrifuge assembly 400 is in an open or loaded state. In this position, the upper housing 404B and the filler 460 can be pivoted out of the interior space of the blood component separation system 200. For example, at least a portion of the upper housing 404B and / or the filler 460 can be placed in the open space of the open access panel 224. In this position, the loading access area 450 can be provided to the circuit connection area 454 of the filler 460. It will be appreciated that orienting the upper housing 404B in the open position provides easy access to the interior of the upper housing 404B and the filler 460. In addition, this arrangement can provide the operator with sufficient clearance to attach the blood component collection circuit 520 to the filler 460 at the circuit connection area 454.

[0251] Reference Figure 4G , shows a perspective view of a filler 460 of a centrifuge assembly 400 according to at least one exemplary embodiment of the present disclosure. In at least one exemplary embodiment, filler 460 can be made of a lightweight material such as plastic, carbon fiber, aluminum, etc. In at least one exemplary embodiment, filler 460 can be 3D printed using a three-dimensional (3D) printer. For example, filler 460 can be produced using additive manufacturing techniques or systems, such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or other additive manufacturing machines. Furthermore, these additive rapid prototyping techniques can allow filler 460 to have more complex geometries that may not be achievable using traditional machining or manufacturing processes. In at least one exemplary embodiment, the material of filler 460 can be selected based on the desired quality of filler 460, the desired physical strength of the manufactured filler 460, and / or the appropriate material for manufacturing.

[0252] The filler 460 may include a circuit connection area 454 disposed approximately in the center of the filler 460. The circuit connection area 454 may include one or more keying or positive positioning features for engaging a portion of the blood component collection circuit 520. Figure 4G As shown, the circuit connection area 454 includes a first positive locating feature 478 disposed along a portion of the central axis of the filler 460. The first positive locating feature 478 can be a keyway, groove, slot, or other feature that engages with a mating feature disposed on the blood component collection circuit 520. In at least one exemplary embodiment, the filler 460 can include a second positive locating feature 480 in the circuit connection area 454. The locating features 478, 480 can prevent the blood component collection circuit 520 from rotating at the circuit connection area 454 and / or prevent the blood component collection circuit 520 from becoming detached from the circuit connection area 454 of the filler 460.

[0253] In at least one exemplary embodiment, the filler 460 can include a collection insert channel 466 configured to receive and at least partially accommodate a blood component collection sac of a blood component collection device, and more specifically, the collection insert channel 466 is configured to receive and at least partially accommodate a blood component collection circuit 520. The collection insert channel 466 can be configured as a groove, a slot, that extends outward from the center of the filler 460 in a generally spiral manner. In at least one exemplary embodiment, the collection insert channel 466 can follow a generally spiral path that can include a first spiral path portion that extends outward from the center of the filler 460 along the length of the periphery of the collection insert channel 466 to a substantially constant radius (e.g., around the center of the filler 460). In any case, the path can be referred to herein as a spiral path or a generally spiral path. The collection insert channel 466 can begin at a channel entrance 468 adjacent to the center of the filler body 464 and terminate at a channel end 472 adjacent to the point farthest from the center of the filler body 464. As Figures 4G to 4IAs shown, the collection insert channel 466 can extend along a generally spiral path 490 extending from a point adjacent to the filler rotation axis 430B to the channel end 472. The generally spiral path 490 can include a channel path inflection point 476 at a point near or adjacent to the channel end 472. The channel path inflection point 476 can extend the collection insert channel 466 a distance from the center of the filler body 464, thereby increasing centripetal and centrifugal forces at the channel end 472 of the collection insert channel 466. In at least one exemplary embodiment, the channel path inflection point 476 can correspond to a key inlet and outlet at a radial maximum within a blood component collection sac 536, which is at least partially inserted or disposed within the collection insert channel 466 of the filler 460. In at least one exemplary embodiment, the filler 460 can include one or more filler balancing protrusions 482 disposed on, in, or around a portion of the filler body 464. These filler balancing protrusions 482 can provide an axially balanced (eg, about the filler rotation axis 430B) filler 460 , particularly when the collection insert channel 466 includes a blood component collection bladder and fluid (eg, blood, blood components, etc.).

[0254] Figure 4I 4 is a schematic plan view of a generally spiral receiving channel or collection insertion channel 466 of a filler 460 according to at least one exemplary embodiment of the present disclosure. The schematic plan view shows a first distance R1 of the collection insertion channel 466 from the center of the filler body 464 (e.g., adjacent to the filler rotation axis 430B, etc.) at a first point along the generally spiral path 490, and a second distance R2 of the collection insertion channel 464 from the center of the filler body 464 after passing a point adjacent to the channel path inflection point 476. Figure 4I As shown, the second distance R2 is further from the center of the filler body 464 than the first distance R1. This increase in distance can occur at a point near or at the channel end 472, such that the centripetal and centrifugal forces within the channel are higher than at any other point along the generally spiral path 490. In at least one exemplary embodiment, the end of the blood collection bladder can substantially coincide with the channel end 472, thereby providing a maximum blood separation force at the end of the bladder.

[0255] Figures 4J to 4LVarious front cross-sections of the filler 460 are shown, and more specifically, various front cross-sections of the collection insert channel 466 and the filler insert chamber 492 disposed within the filler body 464 are shown. In at least one exemplary embodiment, the collection insert channel 466 can include a cross-section or shape that substantially follows a generally spiral path 490 in the filler body 464. The collection insert channel 466 can include an insertion groove that is configured to receive a substantially flat or unfilled blood component collection sac. The blood component collection sac can be inserted into the collection insert channel 466 and the filler insert chamber 492 formed in the filler body 464 along the generally spiral path 490. The filler insert chamber 492 can be defined by one or more side walls 494, 496 that form a cavity that follows the generally spiral path 490. As shown Figure 4K As shown, the filler insertion chamber 492 includes an inner cavity wall 494 spaced a distance from at least one outer cavity wall 496. The filler insertion chamber 492 can be formed in the filler 460 by 3D printing the filler 460 and / or by some other metal or plastic forming operation or operation (e.g., casting, molding, forming, etc.). In at least one exemplary embodiment, the filler insertion chamber 492 can include one or more insertion guide features 498. These insertion guide features 498 can be configured to guide, position, and / or seat the blood component collection capsule within the filler insertion chamber 492 of the filler 460. Although shown as chamfers or lead-in features of the filler insertion chamber 492, the insertion guide features 498 can include one or more fillets, chamfers, bevels, tapers, draft angles, receiving grooves, recesses, and / or other formed materials configured to guide and / or orient a portion of the inserted blood component collection capsule.

[0256] Figure 4LDifferent states of a fluid collection sac (e.g., a blood component collection sac, etc.) disposed within the collection insertion channel 466 and the filler insertion chamber 492 of the filler 460 are shown. As described above, the blood component collection sac can be inserted into the collection insertion channel 466 in a substantially flat or unfilled state S1. In the substantially flat state S1, the blood component collection sac can be sized to enter the upper opening of the collection insertion channel 466 and remain in a pre-filled state within the filler insertion chamber 492. When the filler 460 begins to rotate and separate blood components from the blood provided by the donor 102, the blood component collection sac can expand from the substantially flat first state S1 to an expanded or filled state S2. In at least one exemplary embodiment, the blood component collection sac can expand with the blood and / or blood components until the walls of the blood component collection sac contact the walls 494 and 496 of the filler insertion chamber 492. In at least one exemplary embodiment, the shape of the filler insert chamber 492 can be designed to optimize the amount of fluid that can be collected and / or separated in the filler insert chamber 492 (e.g., maximize the fluid volume while minimizing the amount of material of the filler 460).

[0257] Exemplary Blood Component Collection Devices

[0258] Figures 5A to 5H A blood component collection device 500 is shown, prepared according to at least one exemplary embodiment of the present disclosure. The blood component collection device 500 includes various connectors, such as tubes and connectors. For example, as shown, the blood component collection device 500 can include one or more tubes, such as the cartridge inlet tube 108A, the circuit inlet tube 108B, the anticoagulant tube 110, the circuit outlet tube 112, the saline tube 116, and / or the plasma tube 120, and one or more connectors, such as the tube connector 106 and / or the saline and plasma tube y-connector 280. The blood component collection device 500 can also include one or more other connectors, such as a first tube fitting 504, a second tube fitting 508, a bag fitting 512, a system static circuit connector 528, and / or a filling circuit connector 532. The various connections can fluidly connect the soft cartridge 340 and the blood component collection circuit 520.

[0259] The one or more conduits include a cassette inlet tube 108A, a circuit inlet tube 108B, an anticoagulant tube 110, a circuit outlet tube 112, a saline tube 116, and / or a plasma tube 120 (collectively, "the conduits"), each having a central lumen configured to convey a fluid therethrough. The conduits may comprise one or more polymeric materials, including, for example, PVC, plasticized PVC, polyethylene, EVA, rubber, copolymers, and combinations thereof.

[0260] The one or more connectors include a tube connector 106, a saline and plasma tubing y-connector 280, a first tube fitting 504, a second tube fitting 508, a bag fitting 512, a system static circuit connector 528, and / or a filling circuit connector 532 (collectively, "connectors"), each of which can be configured to fluidically interconnect tubing, and / or fluidically interconnect tubing and other medical accessories, and / or fluidly interconnect tubing and a needle or staple. For example, a connector can be inserted into a central lumen of a corresponding tubing, and / or attached to the exterior of a corresponding tubing, and / or the bag fitting 512 can be configured to be inserted into a receiving bag, such as a saline bag 118. In at least one exemplary embodiment, the connector can include a variety of fittings, including, for example, Luer fittings, twist-connect fittings, and / or other small-bore couplings, to provide a versatile and / or reliable interconnection for establishing a fluid connection.

[0261] As shown, the blood component collection circuit 520 can include a flexible circuit 524 disposed between a system static circuit connector 528 and a filler circuit connector 532. The static circuit connector 528 can be attached to the flexible circuit 524 and / or the blood component collection bladder 536 by a mechanical lock, which can be formed with a light-curing adhesive, as discussed further below. The flexible circuit 524 can be configured as a hollow flexible tube that is configured to receive and / or contain at least a portion of the circuit inlet tube 108B and the circuit outlet tube 112. In at least one exemplary embodiment, the flexible circuit 524 can include a thermoplastic elastomer with enhanced flexibility for transferring torsion from a first end to a second distal end of the flexible circuit 524. Such a thermoplastic elastomer can provide the flexibility of rubber while maintaining the strength and torque properties of plastic. Examples of thermoplastic elastomers can include, for example, copolyesters, DUPONT TM Thermoplastic elastomer, EASTMAN NEOSTAR TM Elastomer, CELANESE Elastomer, TOYOBO and / or other similar brands of elastomers with high flexibility and strength properties.

[0262] In at least one exemplary embodiment, the blood component collection circuit 520 can include a blood component collection bladder 536. The blood component collection bladder 536 can have a first end, or bladder circuit end 540A, and a second end, or bladder free end 540B. The blood component collection bladder 536 can 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 filler circuit connector 532. For example, in at least one exemplary embodiment, fluid can flow between the circuit inlet tube 108B and the first collection flow chamber 544 via the flow path defined by the flexible circuit 524, the system static circuit connector 528, and the filler circuit connector 532. The bladder free end 540B of the first collection flow chamber 544 can include a flow chamber transition 548, and fluid flowing from the bladder circuit end 540A via the first collection flow chamber 544 to the bladder free end 540 can enter the second collection flow chamber 552 via the flow chamber transition 548. The second collection flow chamber 552 can be connected to the flexible circuit 524 via the filler circuit connector 532. For example, in at least one exemplary embodiment, fluid can flow between the circuit outlet tube 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 filler circuit connector 532.

[0263] In at least one exemplary embodiment, Figure 5B As shown, the flexible circuit 524 can include a first independent path 509 and a second independent path 510, the first independent path 509 being configured to receive the circuit inlet tube 108B, and the second independent path 510 being configured to receive the circuit outlet tube 112. For example, in at least some exemplary embodiments, at least a portion of the circuit inlet tube 108B can remain within the first path 509 of the flexible circuit 524 and be connected to the first collection flow chamber 544 at the balloon circuit end 540A via the filler circuit connector 532. Additionally or alternatively, at least a portion of the circuit outlet tube 112 can remain within the second path 510 of the flexible circuit 524 and be connected to the second collection flow chamber 552 at the balloon circuit end 540A via the filler circuit connector 532. In this manner, fluid enters the blood component bladder 536 via the first collection flow chamber 544 , where it can be separated (e.g., into one or more blood components) within the blood component bladder 536 and transported along the second collection flow chamber 552 to the circuit outlet tube 112 maintained within the second path 510 of the flexible circuit 524 .

[0264] As shown, the first collection flow chamber 544 can be separated from the second collection flow chamber 552 by a flow chamber divider 542. In at least one exemplary embodiment, the flow chamber divider 542 can be a sealed portion (e.g., heat sealed) of the blood component collection bladder 536. For example, in at least one exemplary embodiment, the blood component collection bladder 536 can include one or more overlapping and sealed layers of material and can be prepared from one or more overlapping and sealed layers of material. The material layers can include one or more polymeric materials. For example, in at least one exemplary embodiment, the material layers can include PVC, plasticized PVC, polyethylene, EVA, thermoplastics, thermoplastic elastomers, copolymers, and combinations thereof.

[0265] The layer of material may be formed (e.g., cut or otherwise shaped, etc.) and sealed along one or more edges to form the blood component collection pouch 536. Figure 5C and Figure 5D As shown, the flow chamber divider 542 can be formed in the blood component collection bag 536 by sealing one or more material layers to one or more other material layers along one or more preselected paths, and / or sealing one or more first portions of a single material layer to one or more second portions of a single material layer. Figure 5D FIG. 5 shows a blood component collection bladder 536 prior to sealing. The flow chamber divider 542 can be formed as a sealed area of ​​material by joining the bladder first side material 536A to the bladder second side material 536B. The bladder first side material 536A and the bladder second side material 536B can also be sealed at one or more ends 554A, 554B to form the top and bottom of the blood component collection bladder 536. By comparison, Figure 5C The sealed blood component collection bag 536 is shown. Figure 5A and Figure 5B As shown, the seal defining the flow chamber divider 542 does not extend the entire length of the blood component collection bladder 536 , thereby defining a flow chamber transition 548 , allowing fluid to flow between the first collection flow chamber 544 and the second collection flow chamber 552 .

[0266] Once formed, the width of the bladder (WB) may correspond to the uninflated state (S1) (see Figure 4L ) below the first collection flow chamber 544 and / or the second collection flow chamber 552. During operation, as the fluid fills at least a portion of the blood component collection bladder 536, the width of the bladder (WB) may be increased from Figure 5CFor example, in at least one exemplary embodiment, the width (WB) of the bladder can be increased to approximately the size of the filler insertion chamber 492 of the filler 460. In at least one exemplary embodiment, the seal weld portion of the blood component collection bladder 536 can be supported in the filler 460. For example, as Figure 5G and Figure 5H As shown, the top of the filler 460 can support the top two seals 554A, 542, and the bottom of the filler 460 can support the bottom seal 554B.

[0267] In at least one exemplary embodiment, the blood component collection circuit 520 can include one or more locating features (also referred to as key features) 530A, 530B configured to facilitate positive positioning of portions of the blood component collection circuit 520 relative to the blood component separation system 200, and more specifically, relative to the filler 460 of the centrifuge assembly 400. For example, as shown, the blood component collection circuit 520 can include a first connector locating feature 530A located on or near the system static circuit connector 528 and / or a second connector locating feature 530B located on or near the filler circuit connector 532. The locating features 530A, 530B can be configured as keys, tabs, and / or other material protrusions extending from the respective connectors 528, 532. In at least one exemplary embodiment, the second connector locating feature 530B can include a feature that interconnects (e.g., mates) with the first positive locating feature 478 and / or the second positive locating feature 480 of the circuit connection area 454 in the filler 460.

[0268] Figures 5E to 5H are various perspective views of the blood component collection circuit 520 in a bent state, and also illustrate the bent blood component collection bladder 536 of the blood component collection circuit 520 inserted into the filler 460 of the centrifuge assembly 400. Various components of the blood component collection circuit 520 can be flexible and / or capable of being formed or shaped by the application of force. In at least one exemplary embodiment, the flexibility can be elastic, such that shaping of the various portions of the blood component collection circuit 520 does not permanently deform the components.

[0269] Figure 5E The blood component collection circuit 520 is shown in a bent state. Figure 5E, the flexible circuit 524 is shown as being elastically bendable along its length, and the blood component collection bladder 536 is shown as having multiple bends or curves along its length. Nevertheless, the flexible circuit 524 provides fluid to the blood component collection bladder 536, for example, via the circuit inlet tube 108B, and / or removes fluid from the blood component collection bladder 536, for example, via the circuit outlet tube 112, while one or more of the various components of the blood component collection circuit 520 are in a bent state.

[0270] In at least one exemplary embodiment, for example, Figure 5F As shown, the blood component collection circuit 520 can be pre-formed to fit within the collection insert channel 466 of the filler 460 of the centrifuge assembly 400. Pre-forming can include twisting the blood component collection bladder 536 of the blood component collection circuit 520 to match the generally spiral path 490 of the collection insert channel 466. Once pre-formed, features of the blood component collection circuit 520 can be aligned with one or more features of the filler 460, such as Figure 5G As shown. For example, in at least one exemplary embodiment, the filler circuit connector 532 of the blood component collection circuit 520 can be aligned with the circuit connection area 454 of the filler 460 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 can be shaped or formed (e.g., manually or automatically) to match the generally spiral path 490 of the collection insert channel 466 in the filler 460. In at least one exemplary embodiment, the shaping or forming can include aligning the bladder free end 540B of the blood component collection bladder 536 with the channel end 472 of the collection insert channel 466 in the filler 460. When the components are generally aligned with each other, the blood component collection circuit 520 can be moved in a direction toward the collection insert channel 466 and the circuit connection area 454, as shown. Figure 5G In at least one exemplary embodiment, when the filler circuit connector 532 moves toward and into the circuit connection area 454 of the filler 460, the first positive positioning feature 478 can interconnect and / or retain the second connector positioning feature 530B of the filler circuit connector 532 of the blood component collection circuit 520. This interconnection can prevent the filler circuit connector 532 from rotating relative to the filler 460. In at least one exemplary embodiment, this interconnection can retain the filler circuit connector 532 of the blood component collection circuit 520 within the circuit connection area 454 of the filler 460. Figure 5HThe blood component collection circuit 520 is shown loaded in the filler 460. The system static circuit connector 528 and the filler circuit connector 532 can act together to transfer torque applied to the flexible circuit 524 to the blood component collection bladder 536 and the filler 460.

[0271] In at least one exemplary embodiment, fluid (e.g., blood and / or blood components, etc.) contained in the blood component collection bladder 536 of the filler insert chamber 492 of the filler 460 can flow along the first collection flow chamber 544 in a direction around one end of the flow chamber divider 542 toward the bladder free end 540B (e.g., following the blood component movement direction 546) and into the second collection flow chamber 552. In this example, the blood component (e.g., plasma, etc.) can be forced back along the generally spiral path 490 along the second collection flow chamber 552 toward the center of the filler body 464 and through the circuit outlet tube 112 (e.g., to the plasma collection bottle 122).

[0272] Exemplary centrifuge assembly in loop loading state

[0273] Figures 6A to 6C is a schematic cross-sectional view of a centrifuge assembly 400 in various circuit loading states according to at least one exemplary embodiment of the present disclosure. Figures 6A to 6C The centrifuge assembly 400 shown may correspond to the centrifuge assembly 400 described above, in particular in combination with Figures 4D to 4F The centrifuge assembly 400 is described. Specifically, Figure 6A A schematic cross-sectional view showing a first circuit loaded state of the centrifuge assembly 400 is shown, Figure 6B A schematic cross-sectional view showing a second circuit loading state of the centrifuge assembly 400 is shown, Figure 6C A schematic cross-sectional view of the second circuit loading state of the centrifuge assembly 400 is shown.

[0274] exist Figure 6A , centrifuge assembly 400 is shown in an open circuit loading position, wherein upper housing 404B has been pivoted 180 degrees from a closed or operating position. This open position may correspond to Figure 4F The centrifuge assembly 400 is shown in FIG. However, in FIG. Figure 6A 4, the blood component collection circuit 520 has been inserted into the filler 460, and the filler circuit connector 532 is interconnected to the circuit connection area 454 of the filler body 464. The other end of the blood component collection circuit 520 is connected to the fixed circuit connector 402 via the system static circuit connector 528. In this first circuit loaded state, the flexible circuit 524 is fixed to prevent rotation at the fixed circuit connector 402, but rotates synchronously with the filler 460 at the circuit connection area 454.

[0275] exist Figure 6B , centrifuge assembly 400 is shown in a partially closed position, wherein upper housing 404B is being moved from an open position to a closed or operating position. As upper housing 404B pivots, flexible loop 524 can move to a stationary position relative to centrifuge assembly 400. Although flexible loop 524 is rotationally fixed to fixed loop connection 402, filler 460 can freely rotate about filler rotation axis 430B (e.g., limited only by rotationally fixed flexible loop 524).

[0276] exist Figure 6C 4, the centrifuge assembly 400 is shown in a closed or operating position in which the upper housing 404B can be locked to the lower housing 404A (such that the lower housing 404A and the upper housing 404B can rotate synchronously about the centrifuge rotation axis 430). In this position, the flexible circuit 524 can pass from the circuit connection area 454 of the filler 460 through the circuit access gap 436 of the centrifuge split housing 404 to the fixed circuit connection 402. In at least one exemplary embodiment, the flexible circuit 524 can move freely within the circuit access gap 436, with or without contacting one or more portions of the centrifuge split housing 404. In this position, when the centrifuge assembly 400 can rotate about the centrifuge rotation axis 430, the flexible circuit 524, which is fixed at the fixed circuit connection 402, can rotate. The flexible loop 524 is twisted along its length, thereby rotating the filler 460 within the centrifuge assembly 400 (e.g., along the centrifuge rotation axis 430). As described above, the rotation of the filler 460 relative to the centrifuge assembly 400 can be a 2:1 ratio. For example, as the centrifuge assembly 400 rotates one revolution, the rotationally fixed flexible loop 524 (e.g., fixed to the fixed loop connector 402) twists at the loop connection region 454 (e.g., in an attempt to untwist from the rotational twist of the centrifuge assembly 400, etc.), thereby rotating the filler 460 in the same direction of rotation as the centrifuge assembly 400, but approximately two revolutions. By twisting the flexible loop 524 along its length, this rotation of the filler 460 does not require a gear transmission between the centrifuge assembly 400 and the filler 460.

[0277] Exemplary centrifuge assembly in loop loading state

[0278] 7A to 7B A schematic plan view of a centrifuge assembly 400 is shown that automatically loads a circuit into an operational position (eg, blood separation) for centrifugation. 7A to 7B The centrifuge assembly 400 shown in FIG. 4 may correspond to and / or be combined with the previously discussed Figures 4A to 4F and / or Figures 6A to 6COnce the blood component collection circuit 520 has been loaded into the centrifuge assembly 400, as described Figure 6C As shown, the flexible loop 524 can be automatically loaded into the loop engagement position 520B, as shown in FIG. Figure 7A and Figure 7B shown.

[0279] In at least one exemplary embodiment, the flexible loop 524 can extend from the loop connection area 454 of the filler 460 to the fixed loop connector 402 of the blood component separation system 200 when the upper housing 404B is locked to the lower housing 404A. Although the flexible loop 524 can be rotationally secured to the fixed loop connector 402 at the system static loop connector 528, the flexible loop 524 passing through the loop access gap 436 in the centrifuge split housing 404 may not initially be secured or at least partially captured by the loop rotational position guide 424 and / or other features of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop rotational position guide 424 or the loop arm can correspond to an uncaptured loop state 700A. In other words, the flexible loop 524 can be positioned at a certain angle (α) relative to the loop rotational position guide 424, the loop position stop plate 704 and / or one or more loop torsional support bearings 708 or bearing groups. In at least one exemplary embodiment, the loop torsional support bearing 708 can correspond to a state in which the flexible loop 524 is in ... Figure 4B and Figure 4C The circuit receiving area or channel can be formed by the circuit position stop plate 704 and / or one or more circuit torsion support bearings 708 disposed along the length of the upper housing 404B. In at least one exemplary embodiment, the positioning can be designed to Figures 6A to 6C The described circuit is accessible and / or easy to load during loading.

[0280] As the centrifuge assembly 400 rotates in the circuit and filler rotation direction 712 about the centrifuge rotation axis 430, the flexible circuit 524 may move from the uncaptured circuit state 700A to the Figure 7B The captured circuit state 700B is shown. The rotation may be caused by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the circuit and filler rotation direction 712 and / or by the rotor and motor assembly 414 rotating the centrifuge assembly 400 about the centrifuge rotation axis 430. In at least one exemplary embodiment, when the flexible circuit 524 rotates in the circuit and filler rotation direction 712, an outer portion of the flexible circuit 524 may contact a circuit position stop plate 704 or other rotation stop surface of the circuit rotation position guide 424.

[0281] When the flexible circuit 524 is held or at least partially contained within the circuit rotational position guide 424, a portion of the flexible circuit 524 can move within one or more of the circuit torsional support bearings 708. As described above, the flexible circuit 524 can be rotationally secured to the fixed circuit connector 402 by the first connector locating feature 530A of the system static circuit connector 528 associated with the blood component collection circuit 520. This rotationally secured connection prevents the flexible circuit 524 from rotating relative to the blood component separation system 200 at the fixed circuit connector 402. The other end of the flexible circuit 524 can be interconnected at the circuit connection region 454 of the filler 460, where this end can move with the filler 460 and / or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the circuit and filler rotational direction 712, the forces from the flexible circuit 524 that attempt to disentangle or prevent adhesion cause the filler 460 and the end of the flexible circuit 524 connected thereto to rotate.

[0282] In any case, once the fluid separation methods described herein are complete, the centrifuge assembly 400 can be stopped from rotating and the centrifuge split housing 404 can be opened to remove the disposable elements of the blood component collection device 500 from the centrifuge assembly 400. In some cases, the flexible circuit 524 can be removed from the centrifuge assembly 400 by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the circuit and filler rotation direction 712. Figure 7B The capture loop state 700B shown moves to Figure 7A The uncaptured loop state 700A is shown.

[0283] Example functional diagram of an example blood component separation system

[0284] According to at least one exemplary embodiment of the present disclosure, the functional diagram of the blood component separation system 200 may be as follows: Figure 8 The description in this article shows the previous Figures 1 to 7B Components described in , are provided to describe the operation of system 200 for extracting plasma or other blood components from whole blood of donor 102 during a blood component separation step or process.

[0285] System 200 may include an anticoagulant (AC) pump 216. AC pump 216 pumps fluid from AC bag 114 in AC tubing 110. AC pump 216, AC tubing 110, and / or AC bag 114 may be as described above. AC tubing 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within AC tubing 110. AC ADS 804 may be the same or similar in type and / or function to sensor 284 and / or sensor 312 as described above. AC tubing 110 may intersect and fluidically communicate with donor supply tubing 104 and cassette inlet tubing 108A at tubing connector 106. Tubing connector 106 may be any type of connector between tubing 110, tubing 104, and / or tubing 108A as described above.

[0286] Donor feed line 104 is connected to donor 102, which may be penetrated by a lumen needle or other device, thereby allowing whole blood to flow from donor 102 into blood component separation system 200 and allowing blood components to flow back to donor 102. Tubing 108A may be connected to softbox 340. In addition, a donor air detection sensor 312 may be positioned on or in tubing 108A to detect the presence of fluid and / or air within tubing 108A.

[0287] As previously described, the softbox 340 may include a first box port 360A, which may function as, include, and / or be substantially adjacent to a "Y"-shaped connector or segment, or branch, that divides the conduit 108A into a first bypass branch 358A and a first tubing segment 368A (the "Y" segment will be indicated by reference numeral 360A). The two tubing segments 358 and 368 may reconnect at a second box port 360B, which may also function as, include, and / or be substantially adjacent to a second "Y"-shaped connector or segment (the second "Y" segment will be indicated by reference numeral 360B). The conduit 358 is bifurcated by the fluid sensor 316, specifically, dividing the conduit 358 into the first bypass branch 358A and the second bypass branch 358B. Likewise, the pipe 368 is divided into two by the drip chamber 354 . Specifically, the drip chamber 354 divides the pipe 368 into a first pipe section 368A and a second pipe section 368B.

[0288] First pipe segment 368A may include a first fluid control valve 320A. Second pipe segment 368B may similarly include a second fluid control valve 320B. First bypass branch 358A may similarly include a suction fluid control valve 320C. Thus, depending on the configuration and operation of system 200, various sections of pipe 368A, pipe 358A, pipe 358B, and pipe 368B may be isolated by valve 320A, valve 320B, and / or valve 320C.

[0289] The drip chamber 354 can be disposed between the first tubing segment 368A and the second tubing segment 368B. The drip chamber 354 can collect a volume of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) depending on the operation of the system 200, as described below. As previously described, the fluid sensor 316 can be disposed between the first bypass branch 358A and the second bypass branch 358B.

[0290] The inlet tube 108B can be connected to the second cartridge port 360B and can connect the soft cartridge 340 to the flexible circuit 524. The inlet tube 108B can also include a sensor 808 disposed on or in the tube 108B, which is positioned with the tube 108B before being connected to the system static circuit connector 528 of the flexible circuit 524. The pressure sensor (CPS) 808 can detect one or more of, but is not limited to, pressure, the presence of fluid or air, and / or another possible characteristic of the fluid in the tube 108B. In addition, the suction pump 208 can pump fluid away from or into the soft cartridge 340 through the tube 108B.

[0291] Two or more different tubings can be connected to the flexible circuit 524 via the system static circuit connector 528 and provide fluid to or receive fluid from the blood component collection bladder 536. An outlet tube 112 exits the flexible circuit 524 from the system static circuit connector 528. The outlet tube 112 can also include another inline sensor 812 disposed thereon or therein to detect fluid, air, cell concentration, color, and / or color change in the fluid from the flexible circuit 524; the inline sensor 812 can be the same or similar in type and / or function to the aforementioned sensors 804, 312, 320, 808, and / or 284. A second CPS sensor 816, or fluid sensor, can also be disposed in or on the tubing 112. The sensor 816 can detect, but is not limited to, one or more of the following: the presence or absence of fluid, the pressure within the tubing 112, and / or other characteristics of the fluid in the tubing 112. Similarly, sensor 816 may be the same or similar in type and / or function to sensor 804 , sensor 312 , sensor 320 , sensor 808 , sensor 812 , and / or sensor 284 described above.

[0292] The outlet tube 112 can then flow into the plasma air detection sensor 284 before the saline and plasma tube y-connector 280 separates the outlet tube 112 into the saline tube 116 and the plasma tube 120. The reflux pump 212 can interact with the outlet tube 112 and can cause fluid or air to flow through the outlet tube 112 from the flexible circuit 524 or from the saline bag 118 and / or the plasma collection bottle 122.

[0293] The saline bag 118 and associated tubing can be as previously described and can provide saline back to the donor 102 through the system 200. The saline flow control valve 288 can isolate the saline bag 118 from the rest of the system 200. Additionally, the plasma collection bottle 122 can receive plasma from the flexible circuit 524 for processing or separation from whole blood. The plasma collection bottle 122 can be selectively isolated from the system via the plasma flow control valve 286.

[0294] Electrical and control systems

[0295] According to an embodiment of the present disclosure, an embodiment of the electrical and control system 900 for controlling the functions of the blood component separation system 200 may be as follows: Figure 9 The control system 900 may include one or more nodes that may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of the blood component separation system 200.

[0296] Each node can be used to control a different part of the blood component separation system 200. For example, the control system 900 can include a box node 904 and a centrifuge node 908, where the box node 904 can be a soft box assembly system and the centrifuge node 908 can be a centrifuge system. The box node 904 can control or communicate with the components of the blood component collection device 500 (and the related hardware or mechanical components engaged with the soft box assembly 300), and the centrifuge node 908 can control or communicate with the components of the centrifuge assembly 400 (and its related hardware or related mechanical components). The box node 904 and the centrifuge node 908 can communicate wirelessly or through some other electrical or data connection. In some configurations, the box node 904 and the centrifuge node 908 can be separate nodes, specifically, the box node 904 and the centrifuge node 908 can be two parts of a single node 902 or a single system. Therefore, the box node 904 and the centrifuge node 908 can both have the same physical hardware for operation to control different functions. In at least one exemplary embodiment, a single node 902 may include the physical hardware of both a cartridge node 904 and a centrifuge node 908, or a cartridge node 904 may include physical hardware separate from the physical hardware of a centrifuge node 908. Examples of cartridge nodes 904 may be as described in conjunction with Figure 10 The centrifuge node 908 can be combined with Figure 11 As stated.

[0297] Both the box node 904 and the centrifuge node 908 may communicate with one or more sensors 916, 920, and / or 924. As indicated by ellipsis 928, there may be Figure 9924. In the embodiment of the present invention, the sensor shown in box node 904 and centrifuge node 908 can be more or less sensors. Each in box node 904 and centrifuge node 908 can directly communicate with each sensor 916 to 924, or can communicate with multiple sensors 916 to 924 via bus 912. Bus 912 can communicate by any type of communication protocol, such as universal serial bus (universal serial bus, USB), universal asynchronous receive / transmit (universal asynchronous receive / transmit, UART) or other types of bus systems or parallel communication connections. Therefore, bus 912 can be optional, but is shown as a possible communication platform for communicating with various sensors 916 to 924. Sensor 916 to 924 can be any type of sensor, which can transmit information about the existence, color, pressure, etc. of relevant light, fluid, air as described herein. Some sensors in sensor 916 to 924 can include sensors such as air detection sensor 312, fluid sensor 316, ACADS 804, pressure sensor 808, line sensor 812, the second CPS sensor 816 and / or air detection sensor 284. The functions of these sensors 912 to 924 may be as follows.

[0298] The box node 904 and the centrifuge node 908 may also communicate with one or more pump drivers, pump motors, etc. 936, 940, 944, where the pump drivers and pump motors are referred to as "pumps". As shown by the ellipsis 948, there may be more than Figure 9 944。Pumps 936 to 944 may include at least one of the suction pump 208, the return pump 212 and / or the AC pump 216 as described above, or may be a part of at least one of the suction pump 208, the return pump 212 and / or the AC pump 216 as described above。The function of pumps 936 to 944 may be as described herein。

[0299] According to an embodiment of the present disclosure, the embodiment of the box node 904 can be as follows Figure 10 As shown. The box node 904 may include one or more of the following: a controller 1004, a memory 1008, a valve controller 1020, and / or a communication interface for a CAN bus 1016, a UART 1012, or other type of bus. The box node 904 may include other hardware, firmware, and / or software, which are not shown in the figure for clarity.

[0300] The controller 1004 (also referred to herein as a processor) can be any type of microcontroller, microprocessor, field programmable gate array (FPGA), application specific integrated circuit (ASIC), etc. An exemplary controller 1004 can be the NK10DN512VOK10 microcontroller manufactured and sold by N9P Incorporated in the United States, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are also possible. The controller 1004 can control other types of devices or manage the functions of other types of devices, such as valves such as the first fluid control valve 320A, the second fluid control valve 320B, the aspiration fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, and the pumps 936 to 944. In addition, the controller 1004 can communicate with various sensors 916 to 924 or other devices to receive or send information regarding the functioning of the blood component separation system 200.

[0301] Other examples of a processor or microcontroller 1004 as described herein may include, but are not limited to, at least one of the following: 800 and 801, with 4G LTE integration and 64-bit computing 610 and 615, with 64-bit architecture A7 processor, M7 motion coprocessor, series, Core TM series processors, series processors, Atom TM series processors, series processors, i5-4670K and i7-4770K 22nm Haswell, i5-3570K 22nm Ivy Bridge, FXTM series processors, FX-4300, FX-6300 and FX-8350 32nm Vishera, Kaveri processors, CortexTM-M processor, Cortex-A and ARM926EJ-STM processors, other industry equivalent processors, and other examples of processors or microcontrollers 1004 may use any known or future developed standard, instruction set, library, and / or architecture to perform computational functions.

[0302] The memory 1008 may be any type of memory, including random access memory (RAM), read only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, any suitable combination thereof, or other types of storage or memory devices that store and provide instructions for programming and controlling the controller 1004. The memory 1008 may provide all types of software or firmware for programming the functions of the controller 1004, as described below.

[0303] The controller 1004 can communicate with one or more valve controllers 1020. Each valve described herein, such as the first fluid control valve 320A, the second fluid control valve 320B, the aspiration fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, etc., can be controlled by the valve controller 1020 and can be associated with components of the system 200 as described herein. The valve controller 1020 can provide electrical signals, operating instructions, or power to close or open any valve described herein, such as the saline and plasma valve housing 276, the plasma flow control valve 286, the saline flow control valve 288, the first fluid control valve 320A, the second fluid control valve 320B, and / or the aspiration fluid control valve 320C, etc.

[0304] The controller 1004 can also be connected to the bus 912, 932 (e.g., a UART bus, a CAN bus) or other bus via transceivers 1012, 1016 provided external to or integrated into the controller 1004. The UART transceiver 1012 can communicate with one or more of the sensors 916 to 924 or other devices. Similarly, the CAN bus transceiver 1016 can communicate with one or more of the pump controllers 936 to 944 or other devices. The UART transceiver 1012, the bus, the CAN bus transceiver 1016, and the bus are well known in the art and require no further explanation.

[0305] According to an embodiment of the present disclosure, an embodiment of the centrifuge node 908 may be as follows Figure 11 As shown. Centrifuge node 908 may include the same or similar components as box node 904. For example, centrifuge node 908 may include a controller 1104, a UART transceiver 1112, and the like. Similar to controller 1004, controller 1104 may be any type of processor or microcontroller (e.g., the NK10DN512VOK10 microcontroller unit with a 32-bit architecture from N9P Incorporated, USA, as previously described), or other controllers, processors, and the like (e.g., the devices previously mentioned).

[0306] The controller 1104 can communicate directly with the sensors 916 to 924 via the UART transceiver 1112 or via other buses or systems. The controller 1104 can also communicate with a brake controller 1124, which can brake or slow down and stop the centrifuge 400. Similarly, the controller 1104 can communicate with a motor transceiver 1116, which communicates with a motor power system or motor controller used to accelerate or rotate the centrifuge 400, or control the speed setting or other functions of the centrifuge 400.

[0307] In some configurations, the controller 1104 can also communicate with a cuff controller 1120 that can change or set the pressure of the pressure cuff on the donor's arm during the blood component separation process. In addition, the controller 1104 can communicate with and / or control a flashlight 1114, which can be any light that flashes periodically in synchronization with the rotation rate of the motor so that the operator of the blood component separation system 200 can see the operation of the filler 460 as described above. Thus, the controller 1104 can communicate with the flashlight 1114 to change the flashing frequency of the flashlight 1114, the intensity of the flashlight 1114, etc.

[0308] It should be understood that the box node 904 and the centrifuge node 908 include additional components that are described, for example, in U.S. application Ser. No. 17 / 392,804, entitled “Methods and Systems for High-Throughput Blood Component Collection,” filed on August 3, 2021 (Attorney Docket No. 18955-000019-US), the entire contents of which are incorporated herein by reference.

[0309] Exemplary Scanning and Data Control Methods

[0310] In at least one exemplary embodiment, Figure 12AThe data entry process shown can be used to initialize the blood component separation system 200 for each new donor 102. The data entry process can ensure that a target amount or volume of plasma is obtained based on the donor's weight or other donor information. In addition, information such as bottle identification can be entered through the data entry process so that the blood component separation system can record in memory instructions regarding which bottle is used for which donor.

[0311] In at least one exemplary embodiment, Figure 12A The process in FIG. 1 may begin at step 1200, where the blood component separation system 200 may be powered on and await a new donor. The blood component separation system 200 may include: Figure 12B An integrated identification reader (e.g., RFID reader, barcode reader, etc.) 1221 is shown, which is configured to read a code (e.g., RFID tag, barcode, etc.) associated with a particular donor 102 and control the operation of the blood component separation system 200 based on the information read by the identification reader. This 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 can be used for a faster and higher quality donor experience. The code can also be used to label other equipment used in the donation process, such as Figure 12C Label 1227 is shown on bottle 1224 used for plasma collection.

[0312] At step 1203, the reader 1221 of the blood component separation system 200 can be used to scan a barcode, quick response (QR) code, or other type of image to receive data associated with the donor. In at least one exemplary embodiment, the reader 1221 can be configured to read input from an RFID. For example, the donor can use an ID card or other type of object, which can include one or more of the following: a barcode, a QR code, an RFID, etc. By scanning the ID card or other type of object, the blood component separation system 200 can be able to receive data related to the donor.

[0313] Bar codes (e.g., one-dimensional bar codes, two-dimensional bar codes, etc.) can be read by an integrated bar code scanner disposed in front of the blood component separation system. For example, when starting a blood component separation procedure, a user can sequentially scan a donor ID (e.g., from a personal digital assistant (PDA), a mobile phone, a tablet, etc.), a blood component collection device (e.g., a separation device), and / or a plasma collection bottle without requiring further input from the user through a user interface. The system is capable of automatically receiving information and confirming data input without the need for manual input. It will be appreciated that this automatic sequential input of data increases the speed of operation compared to conventional non-sequential input.

[0314] 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 can be used to determine whether the donor is eligible for the donation procedure and to determine specific settings that may be required for the donation procedure, such as the expected total amount of plasma or other information. For example, the donor's height and weight can be used to determine the donor's body mass. The donor's body mass can then be used to determine the target amount or volume of plasma to be collected.

[0315] In at least one exemplary embodiment, information can be transferred between donation sites, blood component separation systems 200, locations, etc. This information can be stored in the form of a nomogram, such as 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 donation.

[0316] The information stored in the nomogram and readable by the integrated identification reader can be limited to information that is permitted to be collected by the blood component separation system 200 (e.g., in accordance with privacy laws, health laws, etc.). In at least one exemplary embodiment, other private information can be stored in the two-dimensional barcode, but can be encrypted or locked to prevent it from being read by the integrated identification reader of the blood component separation system 200.

[0317] The blood component separation 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 the donor 102, which can be used to define the amount or volume of plasma that the donor 102 can provide or donate. As can be appreciated, a donor 102 having a first weight can be allowed to donate a first amount of plasma, while a donor 102 having a second, heavier weight can be allowed to donate a second amount of plasma that is greater than the first amount of plasma. In addition, the body mass of the donor 102 can be used to limit the amount or volume of plasma that the donor 102 can provide or donate. Once the blood component separation system 200 reads the barcode, it can adjust its settings based on this information and stop operating when the desired amount of plasma has been collected, etc.

[0318] The blood component separation system 200 may also be capable of writing information that can be read by other blood component separation systems at the same or other donation locations. For example, donor data may be stored at a network location. The blood component separation system 200 may be capable of transmitting data such as donation results, the donor's current weight, the date and / or time of donation, or other information.

[0319] In at least one exemplary embodiment, the blood component separation system 200 may include one or more computer systems. For example, as will be described below with reference to Figure 16D As discussed in more detail, the blood component separation system 200 may include one or more computer systems 1627, which may include a processor 1630, a memory 1633, an input / output device 1636, one or more pump control systems 1639, one or more sensors 1642 and / or other elements as will be appreciated.

[0320] In at least one exemplary embodiment, as will be referred to below, Figure 16B As discussed in greater detail, the blood component separation system 200 can be capable of communicating with a server 1621 via a network 1618, such as the Internet. In at least one exemplary embodiment, the blood component separation system 200 can communicate with a local computer system, such as a computer located at a donation site, which can be configured to communicate with the server.

[0321] In at least one exemplary embodiment, after receiving data associated with a donor, the blood component separation system 200 may perform a blood component separation process, such as by Figure 12B and Figure 12DThe feedback system of the illustrated graphical user interface (GUI) 1230 confirms receipt of the data associated with the donor. In this way, a nurse, doctor, or other user of the blood component separation system 200 can quickly determine whether the donor information has been correctly entered into the blood component separation system 200. In at least one exemplary embodiment, the feedback system may also or alternatively include a speaker that may be configured to provide auditory feedback.

[0322] At step 1206, the blood component separation system 200 can be configured to determine the identity (ID) of the donor based on the data associated with the donor. For example, the blood component separation system 200 can be configured to use the data received via the scanner 1221 to identify whether the donor is associated with any donor ID information in the database or whether the donor is a new donor. In at least one exemplary embodiment, the scanner 1221 can access the donor information locally or from a server or other computer system via a network connection.

[0323] The donor ID information accessed via the database may include information received from the donor, such as age, body mass, weight, height, and / or target volume (ie, the expected amount of plasma or other donated fluid).

[0324] At step 1209, the blood component separation system 200 may receive data associated with a blood component collection device. The blood component collection device may, for example, include a softbox assembly, such as softbox assembly 300, used during the donation process. The data associated with the blood component collection device may be received by the blood component separation system 200 via a barcode, QR code, RFID chip, or other type of scannable object that may be placed in the blood component collection device. For example, each blood component collection device may be affixed with a label or sticker that may include a different barcode, QR code, RFID chip, or other type of scannable object. By scanning the label or sticker on the blood component collection device, the blood component separation system 200 may be able to record in memory which blood component collection device is currently being used for the donation process. In this way, the blood component separation system 200 may be able to associate a donor with a blood component collection device. Any data received during the scanning process may be recorded in memory and shared with a server or other type of computing system.

[0325] The data associated with the blood component collection device may include the date of manufacture, manufacturer identification, and other information that can be used for data processing after the donation is completed. In at least one exemplary embodiment, the data associated with the blood component collection device received via scanning can be used to determine the type of blood component collection device. The type of blood component collection device can be used by the blood component separation system to adjust one or more settings, such as flow rate or other information, during the donation process.

[0326] In at least one exemplary embodiment, after scanning the blood component collection device, the user of the blood component separation system 200 may be able to receive confirmation of receipt of the information from the blood component collection device. Figure 12D The illustrated graphical user interface 1230 can display an indication of whether data has been received from the blood component collection device. A blood component separation system operator can use such a graphical user interface 1230 during initialization of the blood component separation system for a new donor. In at least one exemplary embodiment, the blood component separation system can play an audible sound through one or more speakers or various colored display lights to indicate that data has been received, instead of or in addition to displaying the information via the graphical user interface.

[0327] At step 1212, the method may include receiving, by the blood component separation system 200, data associated with the plasma collection bottle. For example, in order to initialize the blood component separation system 200 for a new donor, a plasma collection bottle may be required. After the donation, the plasma collection bottle may be filled with the donated plasma. For data tracking purposes, the plasma collection bottle may need to be associated with the donor. For example, information linking the donor to the plasma collection bottle may be stored in a memory. Therefore, it may be necessary to record the identity of the plasma collection bottle. Therefore, a user of the blood component separation system 200 may be able to use the blood component separation system 200 to scan a label, sticker, or other object on or printed on the plasma collection bottle. For example, Figure 12C As shown, the plasma collection bottle 1224 can be affixed with a sticker or label 1227. In some exemplary embodiments, the sticker or label 1227 includes a QR code.

[0328] As with other steps, after receiving data from the plasma collection bottle, the blood component separation system 200 can confirm receipt of the data via a graphical user interface, a speaker, a white display light, or other feedback system.

[0329] At step 1215, the blood component separation system may perform a plasma donation process based on the information received in the above steps. For example, the blood component separation system 200 may use information about the identity of the donor to perform the plasma donation process. The plasma donation process may also use data received from the plasma collection bottle and / or blood components.

[0330] For example, one or more of the donor's body mass and weight can be determined based on the received data associated with the donor, thereby controlling the flow rate during the plasma donation process based on one or more of the donor's body mass and weight. One or more of the donor's body mass and weight can also be determined based on the received data associated with the donor, thereby controlling the collected plasma volume based on one or more of the donor's body mass and weight.

[0331] At step 1218, the process can end, at which point the donation process can continue to complete the extraction of fluid from the donor. Any data received through the above steps can be recorded in memory and / or shared with one or more computer systems. For example, a database entry can be created for a particular donation, including 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.

[0332] At least one exemplary embodiment of the present disclosure includes a method comprising: receiving data associated with a donor through a blood component separation system; determining an identity of the donor based on the data associated with the donor; receiving data associated with a blood component collection device through the blood component separation system; receiving data associated with a plasma collection bottle through the blood component separation system; and performing a plasma donation process through the blood component separation system based on the identity of the donor, the data associated with the blood component collection device, and the data associated with the plasma collection bottle.

[0333] Aspects of the above embodiments include: receiving data associated with the donor includes scanning an image with a scanner. Aspects of the above embodiments include: the scanner is disposed on the blood component separation system. Aspects of the above embodiments include: the image is one of a one-dimensional barcode and a two-dimensional barcode. Aspects of the above embodiments include: the image is displayed on a user device. Aspects of the above embodiments include: receiving data associated with the donor includes scanning an RFID. Aspects of the above embodiments include: after receiving the data associated with the donor, confirming receipt of the data associated with the donor through a feedback system. Aspects of the above embodiments include: the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include: determining, based on the data associated with the donor, that the donor is a new donor. Aspects of the above embodiments include: determining, based on the data associated with the donor, one or more of a body mass and a weight of the donor. Aspects of the above embodiments include: receiving data associated with the blood component collection device includes scanning, with a scanner, one or more of an image and an RFID attached to the blood component collection device. Aspects of the above embodiments include: after receiving the data associated with the blood component collection device, confirming receipt of the data associated with the blood component collection device through a feedback system. Aspects of the above embodiments include: the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include: receiving data associated with the plasma collection bottle includes scanning one or more of an image and an RFID attached to the plasma collection bottle with a scanner. Aspects of the above embodiments include: after receiving the data associated with the plasma collection bottle, confirming receipt of the data associated with the plasma collection bottle by the feedback system. Aspects of the above embodiments include: the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include: determining one or more of a body mass and a weight of the donor based on the received data associated with the donor, thereby controlling the flow rate during the plasma donation process based on one or more of the body mass and the weight of the donor.

[0334] Exemplary Calibration, Maintenance, and Service of Blood Component Separation Systems

[0335] The blood component separation system 200 may include one or more devices, systems, and / or features configured to allow the blood component separation system 200 to be calibrated in the field. For example, the blood component separation system 200 may include one or more devices, systems, and / or features configured to allow the blood component separation system 200 to be calibrated in the field. In other words, the blood component separation system 200 may be calibrated after manufacture and after installation at a donor processing location. Conventional systems cannot be calibrated in the field.

[0336] In at least one embodiment, the blood component separation system 200 can be self-calibrating. The blood component separation system 200 can include a pump and a syringe that uses pressure supplied from, for example, a compressor integrated with the blood component separation system 200 to set a calibrated pressure. In other embodiments, the compressor may not be integrated with the blood component separation system 200 and can be a component separate from the blood component separation system 200. The blood component separation system 200 can also include a test port that is configured to generate a known or calibrated pressure using, for example, the pump and compressor. In at least one exemplary embodiment, the test port is located on the back side of the blood component separation system 200 adjacent to other ports, such as a pressure cuff connection, which can change or set the pressure of a pressure cuff on the donor's arm during the blood component separation process, as described above with respect to Figure 11 As described. The tubing, calibration tubing set, etc. of the blood component collection circuit 520 can be attached to or otherwise interconnected to the test port for testing and / or calibration. When interconnected to the test port, the compressor generates a known calibration pressure, and the pressure sensor in the blood component separation system 200 can be calibrated based on the pressure detected by the pressure sensor. For example, the known calibration pressure can be compared with 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 can be located anywhere in the blood component separation system 200.

[0337] Calibration may also include checking and / or calibrating the holder using a calibration object with a known weight (e.g., a weight certified by the National Institute of Standards and Technology (NIST)). Figure 13A The holder 1300 shown and / or Figures 15A to 15C The bottle tray load cell assembly shown is discussed in greater detail below. In at least one exemplary embodiment, the holder 1300 can be configured to receive the plasma collection bottle 122. The holder 1300 can be disposed on the top cover 210 of the housing 204 and can be similar to the embodiment shown in FIG. Figure 14AThe plasma collection bracket 232C is shown. The holder 1300 may include a weight sensor configured to sense the weight of an object placed on the holder 1300. Thus, during a calibration process, a calibration object may be placed on the holder 1300 and the weight sensor may detect the weight of the calibration object. The difference between the known weight of the calibration object and the detected weight detected by the weight sensor may indicate that the weight sensor may need calibration (which may be automatically triggered by the difference) or maintenance. In at least one exemplary embodiment, if the difference is greater than a predetermined threshold, the blood component separation system 200 may automatically trigger calibration of the weight sensor. In other embodiments, if the difference is greater than a predetermined threshold, a notification may be generated to remind the user to calibrate the weight sensor.

[0338] When one or more components on the blood component separation system 200 are replaced or exchanged, one or more calibration tests and / or calibrations can be performed. For example, replacing or replacing one or more pumps (e.g., pump 208, pump 212, pump 216) can trigger one or more calibration tests. If one or more components of the blood component separation system 200 do not pass the one or more calibration tests, calibration (whether pressure, sensor, weight, etc.) can be automatically performed. If the calibration of one or more components is unsuccessful, the blood component separation system 200 can be locked and not used until each component passes its corresponding calibration test.

[0339] Figure 13B The method 1302 of performing calibration tests and calibration, as shown in the flowchart of FIG. , may begin at step 1304. At the start of the method 1302, one or more calibration tests may be performed or implemented. The one or more calibration tests may be automatically triggered by replacing or replacing one or more components (e.g., one or more slides, sensors, pumps, etc.) of a blood component separation system (such as the blood component separation system 200). In other exemplary embodiments, the one or more calibration tests may be triggered by user input. In still other exemplary embodiments, the calibration tests may be performed prior to using the blood component separation system 200.

[0340] At step 1306, one or more components of the system (e.g., calibration tubing, 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 exemplary embodiments, calibration may be triggered by user input. Calibration may be performed using one or more calibration tools (e.g., pumps, test ports, calibration objects, etc.). Calibration may involve a user interface, such as a GUI, prompting the user to connect one or more calibration tools or components for calibration.

[0341] It should be understood that steps 1304 and 1306 may be repeated (either individually or together). For example, at step 1304, a component may fail the calibration test, the component may be automatically calibrated at step 1306, and the component may be retested at step 1304 to test whether the component is correctly calibrated.

[0342] The blood component separation system 200 may also include one or more protocols to provide service / technical support for the device. These protocols may include calibration (as described above), automated testing (e.g., testing limits and full range), fluid runs (with actual parameters), etc. In at least one exemplary embodiment, a saline check may be performed. In such an embodiment, the blood component separation system 200 may include a weight sensor configured to sense the weight of the plasma collection bottle 122. Saline 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 weight change indicates that saline is properly flowing from the saline bag 118 through the saline tube 116 to the plasma collection bottle 112. In at least one exemplary embodiment, a one-time test may be performed to check for leaks in the blood component collection device 500. In such an embodiment, the blood component separation system 200 may include a pump configured to create a vacuum in the blood component collection device 500. The blood component separation system 200 may also include a sensor to detect such leaks in the blood component collection device 500. In at least one exemplary embodiment, a centrifuge test may be performed to test the centrifuge assembly 400. In such an embodiment, the motor of rotor and motor assembly 414 may be activated to verify proper rotation of centrifuge assembly 400 .

[0343] Exemplary Moving Loop Holder

[0344] 14A to 14F The mobile circuit holder 1400 included in the blood component separation system 200 is shown. As shown, the mobile circuit holder 1400 can be at least partially disposed within a centrifuge chamber 1402 of the blood component separation system 200. The centrifuge chamber 1402 is defined as the interior space of the blood component separation system 200 in which the centrifuge assembly 400 is housed, for example, behind the access plate 224. Figure 14B As shown, mobile circuit holder 1400 can be disposed above centrifuge assembly 400 (eg, offset from centrifuge assembly 400 in the positive z-axis direction). Mobile circuit holder 1400 can correspond to fixed circuit connector 402 or a portion of fixed circuit connector 402 as described above.

[0345] The mobile circuit holder 1400 may include a circuit holder body (also referred to as a circuit holder) 1408 having a circuit connection space (also referred to as a circuit connection) 1412. A portion of the blood component collection device 500 may be held by the circuit connection space 1412. For example, Figure 14C As shown, the circuit connection space 1412 can 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 exemplary embodiment, a connector locking wheel 1424 and a flange 1428 can be used to (securely) lock the system static circuit connector 528 within the circuit connection space 1412. For example, as shown, the system static circuit connector 528 and / or the flexible circuit 524 can be positioned between the connector locking upper wheel 1424 and the flange 1428, and the connector locking upper wheel 1424 can be moved relative to the flange 1428 to apply a retaining pressure to the system static circuit connector 528 and / or the flexible circuit 524. In at least one exemplary embodiment, the mobile circuit retainer 1400 can allow the flexible circuit 524 to be used in the blood component collection device 500 for a shorter distance than would be required without the mobile circuit retainer 1400. In certain variations, the shorter distance can reduce the effective circulation volume of the blood component collection device 500. The shorter distance can reduce waste, such as materials used to manufacture the blood component collection device 500, blood components remaining in the blood component collection device 500 after use, etc. The shorter distance can provide a controlled length of the flexible loop 524, so that the flexible loop 544 resists tangling, snagging, and / or ensures proper loading in the blood component separation system 200.

[0346] The mobile loop holder 1400 can be moved (using an automated process or a manual process) in a first state or an operational state or an extended state (see, for example, FIG. 14A to FIG. 14B and Figure 14D ) and the second state or loaded state or restricted state (see for example Figure 14E). For example, the mobile circuit holder 1400 can be moved (along the x-axis) from an extended position proximate the first side or front side 202 of the blood component separation system 200 to or toward the second side or rear side 206 of the blood component separation system 200. When in the extended position, the mobile circuit holder 1400 can be fixedly coupled to the blood component collection circuit 520. When in the retracted position, the blood component collection circuit 520 can be detached or disconnected from the circuit holder body 1408. For example, the mobile circuit holder 1400 can include a release latch 1404 that can be actuated (e.g., pulled, unlocked, etc.) to unlock the mobile circuit holder 1400 from the first state or locked state to the second state or unlocked state. In the unlocked state, the circuit holder body 1408 can be moved in a retracted direction 1420 (e.g., away from the front 202 of the blood component separation system 200 and / or the housing 204 and toward the rear 206). The retraction direction 1420 can be defined along the x-axis and the z-axis in the XZ plane.

[0347] In at least one exemplary embodiment, for example Figure 14E As shown, retraction of the mobile circuit retainer 1400 can provide clearance for the upper housing 404B to pivot from the interior of the centrifuge chamber 1402 to a position outside the centrifuge chamber 1402 (e.g., compare Figure 4D 、 Figure 4E and Figure 4F For example, when the loop retainer body 1408 moves in the retraction direction 1420, the loop retainer body 1408 can be positioned outside the filler opening pivot arc 1410 that is located between the filler opening and the retraction direction 1420. Figure 14C 4B is shown as an arc-shaped centerline that pivots, for example, about the y-axis. A pivot clearance space 1416 can be provided between the circuit holder body 1408 and the filler opening pivot arc 1410. The pivot clearance space 1416 can allow the upper housing 404B to pivot relative to the lower housing 404A and vice versa (e.g., without the upper housing 404B contacting the circuit holder body 1408, etc.) when the centrifuge split housing 404 is moved between the operating state and the loaded state. For example, when the mobile circuit holder 1400 is in the retracted position, the upper housing 404B can be hinged and flipped to allow the filler 460 to be loaded, such as the blood component collection circuit 520 and the blood component collection bladder 536. Once loaded, the upper housing 404B can be closed and secured in the operating state. When the upper housing 404B is secured in an operative state (e.g., the upper housing 404B and the lower housing 404A are connected), the mobile circuit retainer 1400 can be extended (e.g., moved to an extended state) to retain the blood component collection circuit 520 in a fixed position, for example, relative to the centrifuge assembly 400.

[0348] In at least one exemplary embodiment, when the mobile circuit holder 1400 is arranged in the extended state, the circuit holder body 1408 can be offset from the centrifuge assembly 400 including the upper housing 404B by a first distance 1430A to prevent the upper housing 404B from changing between the operating state and the loaded state, and vice versa. For example, when the circuit holder body 1408 is offset by the first distance 1430A in the extended state, if the upper housing 404B is hinged relative to the lower housing 404A, the upper housing 404B will contact the circuit holder body 1408. In order to move the centrifuge assembly 400 between the operating state and the loaded state, it is necessary to first move the mobile circuit holder 1400 to the retracted state 1400B. When the mobile circuit holder 1400 is in the retracted state 1400B, for example, Figure 14C As shown, the retracted circuit retainer body 1408' can be offset from the centrifuge assembly 400 by a second distance 1430B. The second distance 1430B can be greater than the first distance 1430A and can define a pivot clearance space 1416 between the circuit retainer body 1408 and the filler opening pivot arc 1410. When the upper housing 404B is articulated about the split housing pivot axis 406 (e.g., relative to the lower housing 404A, etc.), the filler opening pivot arc 1410 can correspond to a path associated with the outermost portion of the upper housing 404B. When the mobile circuit retainer 1400 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.

[0349] In at least one exemplary embodiment, the blood component separation system 200 may be inoperable when the mobile circuit holder 1400 is in the retracted state 1400B. The blood component separation system 200 may only allow operation when the mobile circuit holder 1400 is in the extended state. For example, the blood component separation system 200 may include one or more sensors configured to detect the position of the mobile circuit holder 1400 and, based on the detected position, provide input to the blood component separation system 200 including information about the position of the mobile circuit holder 1400. In response, the controller may restrict operation of the blood component separation system 200 when the mobile circuit holder 1400 is in the retracted state, and may allow operation of the blood component separation system 200 when the mobile circuit holder 1400 is in the extended state.

[0350] By moving the mobile loop holder 1400 to the retracted state 1400B and hingedly moving the upper housing 404B to the stowed position (see, e.g., Figure 4F and 6A), a portion of the blood component collection device 500 can be loaded into the blood component separation system 200. In at least one exemplary embodiment, when the upper housing 404B is open and in the loading state, at least a portion of the upper housing 404B can extend outside of the centrifuge chamber 1402. In this "flipped" loading state, the inverted upper housing 404B can provide clearance and accessibility for loading the blood component collection bladder 536 into the filler 460 (e.g., disposed in the upper housing 404B) as described above. When the blood component collection circuit 520 is connected or otherwise coupled to the filler 460, the upper housing 404B can be articulated from the loading state to the operating state (e.g., see Figure 6C In this position, the mobile loop retainer 1400 can be moved from the retracted state 1400B to the extended state (see, for example, Figure 14C ), and the system static circuit connector 528 of the blood component collection circuit 520 can be interconnected with the circuit connection space 1412 of the circuit holder body 1408. Unloading the filler 460 can be performed by reversing the order of the above operations. For example, unloading the filler 460 and / or the centrifuge assembly 400 can include separating the system static circuit connector 528 from the circuit connection space 1412 and moving the circuit holder 1400 from the extended state to the retracted state 1400B. Once in the retracted state 1400B, the upper housing 404B can be rotated or hinged 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 between uses or operations of the blood component separation system 200 to reload the filler 460 and / or the centrifuge assembly 400.

[0351] In at least one exemplary embodiment, the present disclosure provides a blood component separation system. The blood component separation system may include a housing having a front side and a rear side, a centrifuge chamber disposed in the housing, a centrifuge assembly disposed in the centrifuge chamber, and a mobile circuit holder disposed in the centrifuge chamber, wherein the mobile circuit holder includes a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space may be sized to accommodate a connector for a flexible circuit. The mobile circuit holder may be movable between an extended state within the centrifuge chamber and a retracted state within the centrifuge chamber, wherein in the extended state, the circuit holder body is offset from the centrifuge assembly by a first distance, and in the retracted state, the circuit holder body is offset from the centrifuge assembly by a second distance, the second distance being greater than the first distance. In at least one exemplary embodiment, the centrifuge assembly may include a centrifuge housing, which may include a loading state and an operating state. When the mobile circuit holder is in the extended state, the centrifuge housing may be prevented from moving from the operating state to the loading state, while when the mobile circuit holder is in the retracted state, the centrifuge housing may be allowed to move from the operating state to the loading state. In at least one exemplary embodiment, the centrifuge housing may include a split housing comprising a lower housing portion and an upper housing portion, wherein the upper housing portion is hinged relative to the lower housing portion and articulates along an arc when moving between an operating state and a loaded state. In at least one exemplary embodiment, when the mobile circuit retainer is in a retracted state, a clearance space may be provided between the circuit retainer body and the arc to provide a movement path along the arc, allowing the upper housing portion to articulate relative to the lower housing portion between the operating state and the loaded state, avoiding the circuit retainer body. In at least one exemplary embodiment, when the mobile circuit retainer is in an extended state, the clearance space between the circuit retainer body and the arc may be eliminated, thereby preventing the upper housing portion from articulating relative to the lower housing portion between the operating state and the loaded state. In at least one exemplary embodiment, when the mobile circuit retainer is in the retracted state, the circuit retainer body may be positioned closer to the rear side of the housing than when the mobile circuit retainer is in the extended state. In at least one exemplary embodiment, the circuit retainer body may include a connector lock that engages with a connector of the flexible circuit to lock the flexible circuit relative to the circuit retainer body and the circuit connection space. In at least one exemplary embodiment, the movable circuit holder may include a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space may be sized to accommodate a connector of a flexible circuit of a blood component collection device.The movable circuit holder can be movable between an extended state within a centrifuge chamber of a blood component separation system and a retracted state within the centrifuge chamber, wherein in the extended state, the circuit holder body is arranged to be offset from a centrifuge assembly disposed in the centrifuge chamber by a first distance, and in the retracted state, the circuit holder body is arranged to be offset from the centrifuge assembly disposed in the centrifuge chamber by a second distance. The second distance can be greater than the first distance. In at least one exemplary embodiment, the circuit holder body can include a connector lock that engages with a connector of the flexible circuit to lock the flexible circuit relative to the circuit holder body and the circuit connection space.

[0352] In at least one exemplary embodiment, a method for loading a centrifuge with a blood component separation system is provided. The method may include providing a blood component separation system comprising a housing having a front side and a rear side, a centrifuge chamber disposed in the housing, a centrifuge assembly disposed in the centrifuge chamber, and a movable circuit holder 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 is hinged relative to the lower housing portion. The centrifuge housing may have a loaded state and an operating state. The movable circuit holder may include a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space may be sized to accommodate a connector for a flexible circuit. The movable circuit holder may be movable between an extended state within the centrifuge chamber and a retracted state within the centrifuge chamber. In the extended state, the circuit holder body may be offset from the centrifuge assembly by a first distance, and in the retracted state, the circuit holder body may be offset from the centrifuge assembly by a second distance. The second distance may be greater than the first distance. The upper housing portion may be hinged along an arc when moving between the operative state and the stowed state, wherein when the mobile loop holder is in the extended state, the split housing is prevented from moving from the operative state to the stowed state, and when the mobile loop holder is in the extended state, the split housing is allowed to move from the operative state to the stowed state. The method for loading a centrifuge filler may also include: actuating a release lock to unlock the mobile loop holder from a locked state to an unlocked state; moving the mobile loop holder from an extended state to a retracted state; when the mobile loop holder is in the retracted state, hingeing the upper shell part relative to the lower shell part so that the upper shell part is at least partially disposed outside the centrifuge chamber and the upper shell part is in a loaded state; when the upper shell part is in the loaded state, coupling the blood component collection bag and the flexible loop of the blood component collection device to the filler disposed in the upper shell part; when the mobile loop holder is in the retracted state, hingeing the upper shell part relative to the lower shell part so that the upper shell part is disposed in the centrifuge chamber and the upper shell part is in an operating state; and moving the mobile loop holder from the retracted state to the extended state so that the release lock locks the mobile loop holder in the locked state.

[0353] Example bottle pallet with magnetic coupling and load cell overload protection

[0354] Figures 15A to 15M Various views of a load cell assembly and its components are shown according to at least one exemplary embodiment. Figure 15A is a perspective view of a load cell assembly according to at least one example embodiment. Figure 15B According to at least one exemplary embodiment Figure 15A Exploded perspective view of the load cell assembly in Figure 1.

[0355] At least in the exemplary embodiment shown, the load cell assembly 1500 is a bottle pallet load cell assembly. The load cell assembly 1500 includes a fixed portion, a deflection portion ( Figure 15B ) and load cell 1506. In at least one exemplary embodiment, the fixed portion includes a plate 1508 (also referred to as a "mounting plate") and a bracket 1510 (also referred to as a "load cell support bracket"). In at least one exemplary embodiment, the deflection portion includes a first component 1512 (also referred to as a "load interface plate"), a second component 1514 (also referred to as an "overload support rod"), and a bracket 1516 (also referred to as a "bottle bracket" or "plasma collection bracket"). Load cell assembly 1500 can extend along a central or longitudinal axis 1517. In at least one exemplary embodiment, longitudinal axis 1517 passes through the center of load cell 1506.

[0356] In at least one exemplary embodiment, bracket 1516 may be similar to Figure 2A The plasma collection tray 1516 can be attached to the overload support rod 1514. As described above, the plasma collection tray 1516 can be configured to be used in a blood component separation system such as a plasma collection tray 232C. Figure 1 A) receives, orients and / or holds a container (such as a plasma collection bottle, e.g., Figure 15M Bottle 1598 or Figure 26J Container 2716 in FIG. In at least one exemplary embodiment, load cell 1506 is configured to deflect and sense the load and / or weight of the container. Load cell 1506 may be sensitive to forces within a predetermined (or desired) range. For example, when the force applied to load cell 1506 falls outside (e.g., exceeds) the predetermined range, the accuracy of the load measurement and / or the integrity of load cell 1506 may be compromised.

[0357] In at least one exemplary embodiment, the bracket 1516 is coupled to the load cell 1506 via a magnetic coupling and an interface. The magnetic coupling can be configured to mechanically decouple the bracket 1516 from the load cell 1506, thereby reducing or preventing mechanical forces from being applied to the flexure beam and / or the load cell 1506. In at least one exemplary embodiment, as described in greater detail below, upon reaching a predetermined load, the bracket 1516 can break the magnetic interconnection force that separates the bracket 1516, the plate 1508, and the second component 1514 from the blood component separation system 200. Among other things, the magnetic interconnection force can reduce or prevent damage to the load cell 1506, the sensing component, the support element, the flexure beam, and / or other mechanical components disposed between the bracket 1516 and the load cell 1506.

[0358] In at least one exemplary embodiment, first component 1512 includes a first magnet 1518, and second component 1514 includes a second magnet 1520. First magnet 1518 can be coupled to first component 1512 via a first fastener 1522A. Second magnet 1520 can be coupled to second component 1514 via a second fastener 1522B. As will be described in greater detail below, load cell 1506 can be coupled to bracket 1510 via one or more third fasteners 1522C. First component 1512 can be coupled to load cell 1506 via one or more fourth fasteners 1522D. Mounting plate 1508 can be coupled to bracket 1510 via one or more fifth fasteners 1522E. Second component 1514 can be coupled to bracket 1516 via one or more sixth fasteners 1522F. In at least one exemplary embodiment, fasteners 1522A, 1522B, 1522C, 1522D, 1522E, and 1522F may be independently selected from among flat head screws, socket head screws, bolts, and the like.

[0359] Figure 15C According to at least one exemplary embodiment Figure 15A A top perspective view of the mounting plate of the load cell assembly. Figure 15D According to at least one exemplary embodiment Figure 15C Bottom perspective view of the mounting plate in .

[0360] In at least one exemplary embodiment, FIG. 15C to FIG. 15D As shown, mounting plate 1508 includes a substantially planar body 1524 having a first side 1526A and a second side 1526B. Planar body 1524 can define a generally rectangular perimeter (eg, a rectangle with rounded corners).

[0361] In at least one exemplary embodiment, the planar body 1524 defines one or more first holes 1528 (e.g., four holes 1528 as shown). Fasteners (not shown) may extend through the first holes 1528 to attach the load cell assembly 1500 (e.g., via the mounting plate 1508) to the load cell assembly 1500. FIG. 15A to FIG. 15B ) is coupled to a blood component separation system 200 (as shown Figure 1 A). In at least one exemplary embodiment, the vial tray load cell assembly 1500 can be completely removed from the blood component separation system 200 by removing the fasteners. Among other things, this feature allows for quick replacement and / or repair of the vial tray load cell assembly 1500 and / or any components of the vial tray load cell assembly 1500, as will be discussed below. Figure 18A This is described in more detail in the discussion of

[0362] In at least one exemplary embodiment, a first flange 1530 extends from the planar body 1524 on the first side 1526A. The first flange 1530 can define a rectangular shape. In at least one exemplary embodiment, the mounting plate 1508 includes a gasket 1532 (e.g., Figure 15D ). The gasket 1532 can be adjacent to the first flange 1530. When the load cell assembly 1500 (eg FIG. 15A to FIG. 15B ) is coupled to a blood component separation system 200 (as shown Figure 1 A), the gasket 1532 is located between the planar body 1524 of the plate 1508 and the housing 204 (as shown in FIG. Figure 2A In at least one exemplary embodiment, the gasket 1532 may be or include an O-ring, a flat sealing gasket, or another flexible sealing member. Additionally or alternatively, the gasket 1532 may be or include an electromagnetic interference (EMI) shielding gasket (e.g., a metal gasket, a spring, a metalized gasket, etc.).

[0363] In at least one exemplary embodiment, the planar body 1524 defines a second hole 1534. The second hole 1534 can be a central hole. In at least one exemplary embodiment, a second flange 1536 can extend from the second side 1526B of the planar body 1524. The second flange 1536 can be a circular flange. The second flange 1536 can extend around the second hole 1534. In at least one exemplary embodiment, the second component 1514 (e.g., FIG. 15A to FIG. 15B The second member 1514 may be configured to extend through the second hole 1534 at the deflection portion of the load cell assembly 1500 (e.g., FIG. 15A to FIG. 15B 15. In at least one exemplary embodiment, the amount of deflection can be very small, such as less than or equal to about 0.05 inches (e.g., less than or equal to about 0.01 inches, or less than or equal to about 0.005 inches).

[0364] Figure 15E According to at least one exemplary embodiment Figure 15A A perspective view of the bracket for the load cell assembly.

[0365] In at least one exemplary embodiment, Figure 15EAs shown, bracket 1510 includes wall 1538 and third flange 1540. Third flange 1540 may include a first flange portion 1540A and a second flange portion 1540B. First flange portion 1540A and second flange portion 1540B may be spaced apart from each other. First flange portion 1540A and second flange portion 1540B may include respective upper surfaces 1541A and 1541B. Upper surfaces 1541A and 1541B may be coplanar.

[0366] In at least one exemplary embodiment, the wall 1538 defines a receiving slot 1542. The receiving slot 1542 can be defined as a generally rectangular shape. The receiving slot 1542 can receive at least a portion of the load interface plate 1512 and / or at least a portion of the overload support rod 1514, as shown. Figure 15I shown.

[0367] The wall 1538 may further define a recess 1543. The recess 1543 may be defined as a semi-cylindrical shape. The recess 1543 may extend between the receiving slot 1542 and the upper surface 1544 of the wall 1538. The recess may accommodate at least a portion of the overload support rod 1514, such as Figure 15I shown.

[0368] In at least one exemplary embodiment, the bracket 1510 can further include a gusset 1546 extending between the wall 1538 and the third flange 1540. In at least one exemplary embodiment, the wall 1538, the third flange 1540, and the gusset 1546 can cooperate to define an interior bracket area 1547. As will be described in greater detail below, in at least one exemplary embodiment, the load cell 1506, the first component 1512, and a portion of the second component 1514 can be within the interior bracket area 1547. Thus, when the mounting plate 1508 is attached to the housing 204 (e.g., the housing 204 of the blood component separation system 200) Figure 2A As shown), the bracket 1510 can be within a protective portion of the blood component separation system 200 (e.g., protecting the load cell 1506 and / or other components of the load cell assembly 1500 from damage, tampering, and / or the environment external to the blood component separation system 200, etc.).

[0369] In at least one exemplary embodiment, the bracket 1510 is attached to the mounting plate 1508. In the exemplary embodiment shown, the bracket 1510 is attached to the first side 1526A of the mounting plate 1508. The upper surface 1544 of the wall 1538 of the bracket 1510 can define one or more third holes 1550. The fifth fastener 1522E can extend through the third hole 1550 and the plate 1508 to couple the bracket 1510 to the mounting plate 1508. The second flange portion 1540B can define one or more fourth holes 1551. At least in the exemplary embodiment shown, the third fastener 1522C can extend through the fourth hole 1551 to attach the load cell 1506 (e.g., FIG. 15A to FIG. 15B ) is coupled to bracket 1510, as will be described in more detail below.

[0370] Figure 15F According to at least one exemplary embodiment Figure 15A A perspective view of the load cell in the load cell assembly.

[0371] In at least one exemplary embodiment, Figure 15F As shown, the load cell 1506 includes a fixed end 1552 (or fixed side) and a free end 1554 (or free side or load deflection side). Figure 15A As shown, fixed end 1552 is fixed in bracket 1510. Specifically, fixed end 1552 of load cell 1506 can contact second flange portion 1540B. In at least one exemplary embodiment, fixed end 1552 of load cell 1506 can directly contact second flange portion 1540B. Load cell 1506 can be at least partially within inner bracket region 1547 of bracket 1510.

[0372] In at least one exemplary embodiment, the free end 1554 of the load cell 1506 is spaced apart from at least a portion of the bracket 1510 (such as the first flange portion 1540A) to define a deflection region 1556 (also in FIG. Figure 15A and Figure 15I 15). The free end 1554 of the load cell 1506 is configured to move within a deflection region 1556 in response to application of a force or load in a first direction 1558. The first direction 1558 can be substantially parallel to the central axis 1517.

[0373] In at least one exemplary embodiment, load cell 1506 is a flexure-based load cell. When free end 1554 moves or translates relative to fixed end 1552, load cell 1506 can determine a force, weight, or load associated with the measured deflection. While load cell 1506 can be capable of receiving forces perpendicular to the flexible member of load cell 1506 (e.g., in first direction 1558), load cell 1506 can be sensitive to received rotational, torsional, or parallel forces. Examples of load cell 1506 include, but are not limited to, shear beam load cells, S-beam load cells, single point load cells, dual shear beam load cells, bending beam load cells, tank load cells, strain gauges, flexible load cells, and / or combinations thereof.

[0374] Back to FIG. 15A to FIG. 15B In at least one exemplary embodiment, load cell assembly 1500 includes a magnetic coupling between load interface plate 1512 and overload support rod 1514. At least in the exemplary embodiment shown, load interface plate 1512 includes a first magnet 1518 and overload support rod 1514 includes a second magnet 1520. Magnets 1518, 1520 can be arranged so that when overload support rod 1514 is engaged with load interface plate 1512, opposing magnetic poles face each other, as shown. Figure 15I This arrangement induces a magnetic force between magnet 1518 and magnet 1520 to hold overload support rod 1514 in engagement with load interface plate 1512 .

[0375] Figure 15G According to at least one exemplary embodiment Figure 15A A perspective view of the load interface plate of the load support assembly in FIG.

[0376] In at least one exemplary embodiment, Figure 15G As shown, the load interface plate 1512 includes an interface body or first cam body 1560, and an extension or mounting seat 1562. The load interface plate 1512 can define a first side or load cell side 1564A, and a second side or interface side 1564B. The first cam body 1560 can define a first recess or first depression 1566. When assembling the load cell assembly 1500 (e.g., Figure 15A As shown), the load interface axis 1517A can be aligned with the center axis 1517 (as shown). Figure 15A The first magnet 1518 can be at least partially in the first recess 1566. The load interface axis 1517A can extend through the center of the first recess 1566. The first magnet 1518 (as shown) can be aligned with the first magnet 1518 at least partially in the first recess 1566. Figure 15B1566. In at least one exemplary embodiment, the first magnet 1518 can be attached to the overload support rod 1514 via a first fastener 1522A, such as a flat head cap screw. In at least one exemplary embodiment, the surface of the first magnet 1518 can be positioned flush with or below the first cam surface 1567 of the overload support rod 1514.

[0377] In at least one exemplary embodiment, first cam surface 1567 defines a plurality of valleys 1568. At least in the exemplary embodiment shown, plurality of valleys 1568 include a first valley 1568A, a second valley 1568B, and a third valley 1568C. Valleys 1568 can be asymmetrically arranged about load interface axis 1517A (e.g., having centers spaced approximately 90° apart). In at least one exemplary embodiment, each valley 1568 can be configured as a dwell or recess having at least one inclined, chamfered, or tapered side.

[0378] In at least one exemplary embodiment, first cam surface 1677 may further define a first flat portion 1569. In the exemplary embodiment shown, first flat portion 1569 is located between first valley 1568A and third valley 1568C. First flat portion 1569 may extend uninterrupted between first valley 1568A and third valley 1568C. Valleys 1568A, 1568B, 1568C, and first flat portion 1569 may circumferentially surround first recess 1566.

[0379] In at least one exemplary embodiment, second side 1564B of first cam body 1560 can further define a plurality of notches 1570. Each notch 1570 can correspond to a corresponding valley 1568. Notch 1570 can be located in the center of each corresponding valley 1568.

[0380] Extension 1562 can be adjacent to first cam body 1560. At least in the exemplary embodiment shown, extension 1562 defines a generally rectangular cross-section. Extension 1562 can define one or more fourth holes 1571. Fourth holes 1571 can receive fourth fasteners 1522D to couple load interface plate 1512 to load cell 1506 (e.g., Figure 15B shown).

[0381] Figure 15H According to at least one exemplary embodiment Figure 15A A perspective view of the overload support rod of the load cell assembly.

[0382] Reference Figure 15H In at least one exemplary embodiment, the overload support rod 1514 includes a spindle 1572 that extends along a longitudinal or support rod axis 1517B (e.g., Figure 15A In at least one exemplary embodiment, the overload support rod 1514 includes a second cam body 1574 at the first end 1573A and a coupling portion 1775 at the first end 1573A.

[0383] In at least one exemplary embodiment, the diameter of the coupling portion 1575 is greater than the diameter of the spindle 1572. The coupling portion 1575 can define a receiving slot, such as a fifth hole 1575A. The fifth hole 1575A can cooperate with the sixth fastener 1522F to secure the bracket 1516 (e.g., Figure 15A shown) coupled to the overload support rod 1514.

[0384] In at least one exemplary embodiment, the second cam body 1574 is substantially cylindrical. The second cam body 1574 can define a second recess or second depression 1576. The support rod axis 1517B can extend through the center of the second recess 1576. When the load cell assembly 1500 (e.g. Figure 15A When the support rod axis 1517B is assembled as shown, the support rod axis 1517B can be aligned with the central axis 1517. The second magnet 1520 can be at least partially in the second recess 1576. Figure 15B 1576. In at least one exemplary embodiment, the second magnet 1520 can be attached to the overload support rod 1514 via a second fastener 1522B, such as a flat head cap screw. In at least one exemplary embodiment, the surface of the second magnet 1520 can be positioned flush with or below the second cam surface 1577 of the overload support rod 1514.

[0385] In at least one exemplary embodiment, second cam surface 1577 defines a plurality of lobes 1578. At least in the exemplary embodiment shown, plurality of lobes 1578 includes a first lobe 1578A, a second lobe 1578B, and a third lobe 1578C. Lobes 1578 can be asymmetrically arranged about support rod axis 1517B (e.g., having centers spaced approximately 90° apart from each other). In at least one exemplary embodiment, each lobe 1578 can be configured as a protrusion having at least one inclined or tapered side extending from a tip of the protrusion.

[0386] In at least one exemplary embodiment, second cam surface 1577 of second cam body 1574 may further define a second flat portion 1579. In the exemplary embodiment shown, second flat portion 1579 is between first lobe 1578A and third lobe 1578C. Second flat portion 1579 may extend uninterrupted between first lobe 1578A and third lobe 1578C. Lobe 1578 and second flat portion 1579 may circumferentially surround second recess 1576.

[0387] In at least one exemplary embodiment, the convex corners 1578 and the concave valleys 1568 (e.g., Figure 15G A benefit of the asymmetric arrangement (shown in FIG. 15 ) is that the overload support rod 1514 can engage the load interface plate 1512 in only one orientation (e.g., to prevent the plasma collection cradle 1516 from being incorrectly installed in the blood component separation system 200, etc.). Furthermore, in at least one exemplary embodiment, this asymmetric arrangement can ensure that the plasma collection cradle 1516 is always installed in substantially the same orientation relative to the blood component separation system 200.

[0388] In at least one exemplary embodiment, referring to Figures 15G to 15H , valley 1568 (e.g. Figure 15G The arrangement of the trough 1568 can provide at least one mating surface at each location of the trough 1568, which is configured to mate with the convex corner 1578 (as shown in FIG. Figure 15H When overload support rod 1514 is engaged with load interface plate 1512 (e.g., in an engaged state), first cam lobe 1578A may be aligned with and located within first valley 1568A, second lobe 1578B may be aligned with and located within second valley 1568B, and third lobe 1578C may be aligned with and located within third valley 1578C. In at least one exemplary embodiment, first cam surface 1567 may be in continuous and uninterrupted contact with second cam surface 1577.

[0389] In at least one exemplary embodiment, when overload support rod 1514 is tilted, twisted, or rotated relative to load interface plate 1512 (e.g., by applying Figure 15A When the overload support rod 1514 is rotated about the axis 1517B, at least one of the plurality of lobes 1578 can contact the first flat portion 1569 of the load interface plate 1512.

[0390] Figure 15I According to at least one exemplary embodiment Figure 15A A partial cross-sectional view of the load cell assembly in the engaged state. Figure 15J According to at least one exemplary embodiment Figure 15A A partial cross-sectional view of the weighing sensor assembly in a disengaged state, wherein a portion of the first magnet is cut away.

[0391] In at least one exemplary embodiment, Figures 15I to 15J As shown, each of magnets 1518 and 1520 has a first magnetic pole side 1580A (e.g., a north pole) and a second magnetic pole side 1580B (e.g., a south pole). First magnetic pole side 1580A has a first polarity, and second magnetic pole side 1580B has a second polarity opposite to the first polarity. Magnets 1518 and 1520 are arranged so that opposite poles (i.e., poles with opposite polarities) face each other. In the exemplary embodiment shown, first magnet 1518 is positioned in first recess 1566 of load interface plate 1512 such that first magnetic pole side 1580A of first magnet 1518 faces overload support rod 1514. Second magnet 1520 is positioned in second recess 1576 of overload support rod 1514 such that second magnetic pole side 1580B of second magnet 1520 faces load interface plate 1512. In at least one other exemplary embodiment, the load cell assembly may include a single magnet disposed in the load interface plate or the overload support rod, with magnetically attractive metal (eg, iron, steel, etc.) disposed in the other of the load interface plate or the overload support rod.

[0392] When the overload support rod 1514 receives a predetermined movement and / or force, the overload support rod 1514 is moved Figure 15I The engagement state shown and Figure 15J By moving between the illustrated disengaged states, the bottle tray load cell assembly 1500 can provide overload protection for the load cell 1506 and / or other components. The motion and / or force can correspond to rotation about the central axis 1517 in a rotational direction 1582, a moment about the axis 1517, a moment about the illustrated y-axis, a moment about the illustrated x-axis, and / or a combination thereof. Furthermore, the ability to disengage the overload support rod 1514 from the load interface plate 1512 prevents nonlinear forces (e.g., forces that do not act solely along the z-axis to provide a weight vector, etc.) from damaging the load cell 1506 and / or components of the bottle tray load cell assembly 1500. The ability to disengage the overload support rod 1514 from the load interface plate 1512 prevents nonlinear forces (e.g., forces that do not act solely along the z-axis to provide a weight vector, etc.) from damaging the load cell 1506 and / or components of the bottle tray load cell assembly 1500.

[0393] In at least one exemplary embodiment, Figure 15J As shown, a force is received in a first rotational direction 1582A, causing the overload support rod 1514 to rotate counterclockwise relative to the load interface plate 1512. This force may be caused by an accidental knock and / or twisting of the bracket 1516, causing the overload support rod 1514 to rotate about the axis 1517. As the overload support rod 1514 rotates, the lobes 1578 may travel along the angled or tapered sides of the valley 1568, raising the overload support rod 1514 relative to the load interface plate 1512 and causing the overload support rod 1514 to at least partially separate from the load interface plate 1512. In at least one exemplary embodiment, in a fully disengaged state, the overload support rod 1514 is separated from the load interface plate 1512 by a separation offset distance 1583. In this position, the lobes 1578 may contact the first flat portion 1569 of the load interface plate 1512 and be removed or disengaged from the valley 1568.

[0394] When the overload support rod 1514 is separated from the load interface plate 1512, a separation space 1584 can be defined between the overload support rod 1514 and the load interface plate 1512. The separation space 1584 can create a sufficient gap between the first magnet 1518 and the second magnet 1520 so that a continuous rotational force applied to the overload support rod 1514 does not exert a specific force (e.g., torsion, rotation, and / or torque, etc.) on the load interface plate 1512. In at least one exemplary embodiment, when in a disengaged state (e.g., due in part to the separation offset distance 1583), the magnetic force between the magnets 1518 and 1520 is less than when in an engaged state (e.g., due in part to the separation offset distance 1583). Figure 15I 15. The load cell 1506 is thus protected from any sustained rotational forces or moments. To reset the bottle pallet load cell assembly 1500, the overload support bar 1514 can be rotated until the convex corner 1578 is aligned with the concave valley 1568, which moves the overload support bar 1514 toward the load interface plate 1512 and reduces and / or closes the separation offset distance 1583.

[0395] Figure 15K According to at least one exemplary embodiment Figure 15A Side elevation view of the bracket for the load cell assembly.

[0396] In at least one exemplary embodiment, Figure 15KAs shown, the bracket 1516 includes a wall 1586 that at least partially defines a container area 1587. The wall 1586 can be partially cylindrical. A lid 1588 can be coupled to the wall 1586 to facilitate alignment and / or retention of a container within the container area 1587. In at least one exemplary embodiment, the lid 1588 facilitates positioning a container (e.g., see FIG. 1 ) by lifting the port end or top of the container before the bottom of the container. Figure 15M The container 1598) is properly removed from the bracket 1516, thereby reducing or preventing leakage of the container contents from the vent port of the container.

[0397] Wall 1586 may extend between a first end 1586A and a second end 1586B. In at least one exemplary embodiment, second end 1586B of wall 1586 includes a pair of alignment surfaces 1589. An alignment angle 1590 may be defined between alignment surfaces 1589. In at least one exemplary embodiment, alignment angle 1590 is greater than or equal to approximately 90° (e.g., greater than or equal to approximately 100°, greater than or equal to approximately 110°, greater than or equal to approximately 120°, greater than or equal to approximately 130°, greater than or equal to approximately 140°, or greater than or equal to approximately 150°). Alignment angle 1590 may be less than or equal to approximately 160° (e.g., 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 may at least partially mate to define an alignment region 1591. In at least one exemplary embodiment, wall 1586 further defines a slot 1592 between alignment surfaces 1589. In at least one exemplary embodiment, alignment surfaces 1589 and / or slot 1592 can facilitate proper alignment of a container within rack 1516, as will be described in greater detail below.

[0398] In at least one exemplary embodiment, wall 1586 defines one or more receiving slots 1586C. Receiving slots 1586C can be configured to receive at least a portion of a calibration weight. At least in the illustrated exemplary embodiment, receiving slots 1586C are sized and shaped to receive the bottom of a cylindrical calibration weight. When the cylindrical calibration weight is at least partially within receiving slots 1586C, the longitudinal axis of the cylindrical calibration weight is substantially parallel to the longitudinal axis of load cell assembly 1500 (e.g., Figure 15A The central axis 1517 (as shown) Figure 15A shown).

[0399] Figure 15L According to at least one exemplary embodiment Figure 15K Front elevation of the bracket in .

[0400] In at least one exemplary embodiment, Figure 15LAs shown, bracket 1516 can be configured to hold the container in a desired orientation. Bracket 1516 can define a container angle 1594 between the bottom of wall 1586 and a horizontal plane 1595 (i.e., a plane perpendicular to the direction of gravity). In at least one exemplary 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 container angle 1594 can be less than or equal to about 45° (e.g., less than or equal to about 40°, less than or equal to about 35°, less than or equal to about 30°, less than or equal to about 25°, less than or equal to about 20°, less than or equal to about 15°, less than or equal to about 10°, less than or equal to about 8°, or less than or equal to about 5°).

[0401] Figure 15M According to at least one exemplary embodiment Figure 15K A perspective view of a container in a carrier.

[0402] In at least one exemplary embodiment, Figure 15M As shown, the bracket 1516 is configured to hold the container in a desired orientation. At least in the exemplary embodiment shown, the container is a bottle 1598. The bottle 1598 can be Figure 19A 1598G. Figure 19I and Figure 19J ).

[0403] In at least one exemplary embodiment, when bottle 1598 is properly oriented in bracket 1516, protrusion 1598B is at least partially within alignment region 1591. Alignment surface 1589 of bracket 1516 engages (e.g., is in direct contact with) container alignment surface 1598C, and fluid port 1598F is at least partially located within groove 1592. Thus, vent port 1598G is positioned higher than fluid port 1598F, above a predetermined (or desired) liquid level. In this orientation, the fill capacity of bottle 1598 can be increased or maximized compared to other orientations because placing vent port 1598G at the top allows for a larger fill volume without spilling contents through vent port 1598G. Furthermore, this orientation can reduce or minimize residual volume, allowing fluid to be drawn from bottle 1598 without inhaling air. Container 1598 is oriented at container angle 1594. The container angle 1594 can be selected to balance residual requirements and high fill volume.

[0404] In at least one exemplary embodiment, as will be described below in the accompanying Figure 26J As discussed in more detail in the discussion of , the size and shape of the bottle 1598 and / or lid 1598A can ensure that the lid 1598A of the bottle 1598 is properly positioned under the bottom of the bottle 1598 in the cradle 1516. That is, the lid 1598A can be oriented toward the first end wall 1586A and the bottom of the bottle 1598 can be oriented toward the second end wall 1586B.

[0405] In at least one exemplary embodiment, the bottle 1598 and the rack 1516 include one or more features to facilitate visual identification of improper loading. A user can easily identify when the bottle 1598 is loaded at a different angle than the container 1594 (e.g., Figure 15K 1592G, i.e., when the longitudinal axis of the bottle 1598 is not parallel to the bracket 1516. Additionally or alternatively, a user can easily identify when the container alignment surface 1598C is not fully seated on the alignment surface 1589 of the bracket 1516. Additionally or alternatively, a user can identify when the ports 1598F, 1598G are not vertically aligned with the fluid port 1598F in the slot 1592G. Additionally or alternatively, a user can identify when the label 1598I of the bottle 1598 is not visible, is facing upward, and / or is substantially centered within the bracket 1516.

[0406] In contrast, in at least one exemplary embodiment, when bottle 1598 is in an incorrect orientation within cradle 1516, the opposing surface engages one or both of alignment surfaces 1589, thereby preventing protrusion 1598B from being positioned within alignment region 1591. In an incorrect orientation, fluid may be pushed from bottle 1598 through vent port 1598G, which may be below the fluid level in the incorrect orientation. When the flow is reversed, air may be drawn from bottle 1598 instead of the intended fluid.

[0407] An exemplary aspect relates to a bottle pallet load cell assembly comprising: a support bracket; 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 attached to the support bracket; an interface plate attached to the load deflection side of the load cell, the interface plate comprising: a body; a first magnet recess disposed in the body; and a plurality of cam lobe valleys at least partially surrounding the first magnet recess, wherein the plurality of cam lobe valleys interrupt a first contact surface of the body; a support rod comprising: a spindle extending along a longitudinal axis from a first end of the spindle Extending to the second end of the spindle; a cam body, which is arranged at the second end of the spindle; a second magnet recess, which is arranged in the cam body; and a plurality of cam lobes extending from the cam body, which are arranged at least partially around the second magnet recess; wherein the support rod can move between a state of engagement with the interface plate and a state of disengagement from the interface plate, wherein in the engaged state, the plurality of cam lobes are arranged to contact the plurality of cam lobe valleys, wherein in the disengaged state, the plurality of cam lobes are arranged not to contact the plurality of cam lobe valleys, but to contact the first contact surface of the body.

[0408] Any one or more of the above aspects further include: a first magnet disposed in a first magnet recess, the first magnet including a first pole having a first polarity, the first magnet facing away from the main body of the interface plate; and a second magnet disposed in a second magnet recess, the second magnet including a second pole having a second polarity, the second pole facing away from the cam body of the support rod, wherein the first pole faces the second pole, and the first polarity is opposite to the second polarity. Any one or more of the above aspects further include: the support rod is held in an engaged state with the interface plate by a magnetic force between the first magnet and the second magnet, and a first movement of the support rod relative to the interface plate separates the support rod from the interface plate by a distance and moves the support rod from an engaged state with the interface plate to a disengaged state with the interface plate. Any one or more of the above aspects further include: the first movement includes rotational movement about a longitudinal axis, the rotational movement including a force greater than the magnetic force. Any one or more of the above aspects further include: a collection bracket fixedly attached to the first end of the spindle. Any one or more of the above aspects further include: the load deflection side moves independently of the support bracket. Any one or more of the above aspects include: the plurality of cam lobe valleys include at least three cam lobe valleys, the at least three cam lobe valleys are asymmetrically arranged about an axis extending through the center of the first magnet recess, and the plurality of cam lobes include at least three cam lobes. Any one or more of the above aspects include: the at least three cam lobes engage with the at least three cam lobe valleys in a single rotational direction about the axis passing through the center of the first magnet recess. Any one or more of the above aspects include: the support rod rotates about the longitudinal axis in the disengaged state without applying a rotational force to the load cell via the interface plate.

[0409] An exemplary aspect relates to a method for disengaging a support member from a weighing assembly, the method comprising: providing a weighing sensor assembly, the weighing sensor assembly comprising: a support bracket; a weighing sensor, the weighing sensor comprising a fixed side and a load deflection side offset from the fixed side, wherein the fixed side of the weighing sensor is attached to the support bracket; an interface plate, the interface plate being attached to the load deflection side of the weighing sensor, the interface plate comprising: a body; a first magnet recess disposed in the body; and a plurality of cam lobe valleys at least partially surrounding the first magnet recess, wherein the plurality of cam lobe valleys interrupt a first contact surface of the body; a support rod, the support rod comprising: a spindle extending a length along a longitudinal axis from a first end of the spindle to a second end of the spindle; a cam body, the cam body being disposed at the second end of the spindle; a second magnet recess, the second magnet recess and a plurality of cam lobes extending from the cam body, the plurality of cam lobes being arranged at least partially around the second magnet recess; wherein the support rod can move between an engaged state with the interface plate and a disengaged state with the interface plate, wherein in the engaged state, the plurality of cam lobes are arranged to contact the plurality of cam lobes valley portions, and in the disengaged state, the plurality of cam lobes are arranged not to contact the plurality of cam lobes valley portions but to contact the first contact surface of the body; positioning the support rod in an engaged state with the interface plate so that the plurality of cam lobes contact the plurality of cam lobes valley portions; receiving a moving force at the support rod to move the support rod from the engaged state to the disengaged state, wherein the moving force includes a rotational force around the longitudinal axis; and moving the support rod independently of the interface plate and not applying a specific rotational force to the interface plate and the weighing sensor when in the disengaged state.

[0410] Exemplary Communication Methods for Blood Component Separation Systems

[0411] In at least one exemplary embodiment, the blood component separation system 200 as described herein may include one or more computer systems, such as computer system 1627. The processor 1630 of computer system 1627 may be configured to perform one or more processes and methods described herein. The processor 1630 may execute software. For example, the software may include firmware, applications, and / or an operating system that may manage the execution of the blood component separation system 200.

[0412] Software (including firmware, applications, operating systems, and other programmable features of the blood component separation system 200) may be updated from time to time to ensure that the blood component separation system 200 operates as desired.

[0413] The blood component separation system 200 may include an application that, among other things, may perform fleet management and allow customers to install software for large groups of devices. The software system implemented by the blood component separation system 200 may be configured to generate and / or compile device logs (D-logs) to be sent to a cloud storage location. The device logs may be used for predictive analysis or other purposes. Figure 16B As shown, each blood component separation system 200 can communicate with a remote system server 1621 (e.g., via a communication network 1618, a cloud, etc.). During startup, each blood component separation system 200 can use Figure 16A The method shown passes information about the software (including firmware version, error logs encountered, etc.) to the server 1621.

[0414] The system server 1621 can be configured to determine whether the software and / or firmware version of the blood component separation system 200 needs to be updated (e.g., is outdated, etc.). In at least one exemplary embodiment, the system server 1621 can automatically force the software and / or firmware update, or provide the user with the option to update the software and / or firmware. In at least one exemplary embodiment, an external device can be connected to the blood component separation system 200 to update the software. For example, the external device can be a computer or laptop computer configured to connect to the blood component separation system 200 and update the software of the blood component separation system 200. In any case, if the software of the blood component separation system 200 is not updated, the blood component separation system 200 may be blocked from operating. This blocking can be based on a lock signal sent by the system server 1621, or the blood component separation system 200 not receiving an unlock signal from the system server 1621 to allow operation.

[0415] Figure 16A The method may begin at step 1600, wherein the blood component separation system 200 may be in an off or unused state. At step 1603, the blood component separation system 200 may be powered on and may undergo a startup process. Figure 16D The illustrated computer system 1627 can be configured to detect activation of the blood component separation system 200, or the computer system 1627 can be configured to automatically perform the processes as described herein upon activation.

[0416] In response to detecting the start-up, computer system 1627 may transmit data to server 1621 via a connection to network 1618, such as Figure 16B The data transmitted to the server 1621 may include one or more of the following: a data log, a firmware version identifier, and an error log.

[0417] At step 1609, in response to the data sent to server 1621, the blood component separation system 200 may receive a response from server 1621. Server 1621 may be configured to determine whether the software of the blood component separation system 200 is current and / or up to date based on the data. If the software is outdated or not up to date, server 1621 may send a lock signal or other type of data packet indicating that the blood component separation system 200 requires a software update before use. In at least one exemplary embodiment, the blood component separation system 200 may be unusable until positive confirmation is received from server 1621 via network connection 1618 that the software is up to date. In this manner, risks associated with using an outdated blood component separation system 200 may be avoided. For example, at step 1612, use of the blood component separation system 200 may be prevented based on the response received from the server.

[0418] In at least one exemplary embodiment, if the server 1621 determines that the software is out of date, the server may send one or more files for updating the software as part of its response. Additionally or alternatively, the software of the blood component separation system 200 may be automatically updated. For example, a software update may be automatically initiated after receiving one or more files for updating the software from the server. In at least one exemplary embodiment, upon receiving one or more files for updating the software, the blood component separation system 200 may enable a user to manually update the system. For example, after receiving the one or more files, the user may manually initiate a software update. Once the software has been updated, the blood component separation system 200 may be configured to unlock and allow system use.

[0419] In at least one exemplary embodiment, Figure 16A The method shown in may also include: after preventing use of the blood component separation machine, determining whether an unlock requirement has been met. For example, the unlock requirement may include appropriately updating software. In response to determining that the unlock requirement has been met, the blood component separation system 200 may enable use.

[0420] In at least one exemplary embodiment, the message may be displayed on the graphical user interface 1624 of the blood component separation system 200, such as Figure 16C 16. This message can inform the user if the blood component separation system 200 is locked due to outdated software and can enable the user to manually install updated software if needed. In at least one exemplary embodiment, the user can manually initiate the installation of the software update using a graphical user interface (GUI) 1624. In other embodiments, the user can connect an external device containing updated software to the blood component separation system 200 to initiate and install the software update.

[0421] At least one exemplary embodiment includes a method comprising: detecting activation of a blood component separation machine; transmitting data to a server in response to detecting the activation; receiving a response from the server in response to the data; and preventing use of the blood component separation machine based on the response from the server.

[0422] Aspects of the above embodiment include: the data transmitted to the server includes one or more of the following: a data log, a firmware version identifier, and an error log. Aspects of the above embodiment include: the response includes a lock signal. Aspects of the above embodiment include: the response includes a firmware update. Aspects of the above embodiment include: automatically installing the firmware update. Aspects of the above embodiment include: after installing the firmware update, the blood component separation machine is unblocked from use. Aspects of the above embodiment include: the firmware update is manually installed by a user. Aspects of the above embodiment include: based on the response from the server, a message is displayed on a graphical user interface. Aspects of the above embodiment include: the graphical user interface enables the user to initiate firmware installation. Aspects of the above embodiment include: after blocking use of the blood component separation machine, determining that an unlocking requirement has been met; and in response to determining that the unlocking requirement has been met, enabling use of the blood component separation machine. Aspects of the above embodiment include: the unlocking requirement is associated with the updated firmware.

[0423] Example methods and processes for providing feedback on the donation process

[0424] The blood component separation system 200 may include one or more interface elements (e.g., display devices, light emitting diodes (LEDs), alarms, etc.) that provide information about the donation process to the user and / or donor 102. In one example, these interfaces may indicate to the donor 102 that the donor 102 should squeeze (e.g., when pressure or flow rate drops below a predetermined threshold, etc.). Additionally or alternatively, the interface elements may indicate to the donor 102 the progress of the donation process. In any case, the feedback may be provided by the blood component separation system 200 with auditory and / or visual output (e.g., via one or more speakers, display devices, LEDs, etc.). In at least one exemplary embodiment, an LED may be arranged on a side of the blood component separation system 200 that provides the feedback to the donor 102.

[0425] Figure 17A The method shown in the flowchart in may begin at step 1700. At the start of the method, a blood component separation system (such as blood component separation system 200) may be powered on and connected to a donor (such as donor 102).

[0426] At step 1703, the computer system of the blood component separation system 200 may detect the start of the donation process. In at least one exemplary embodiment, the detection itself may not be required, but may be performed automatically as part of the donation process. Figure 17A For example, detecting the start of the donation process may include initiating the donation process. In at least one exemplary embodiment, detecting the start of the donation process may include detecting the flow of fluid, for example, by using one or more sensors (such as fluid sensor 316).

[0427] At step 1706, once the donation process begins, the blood component separation system may provide an output that is noticeable to the donor 102. For example, the output may be a light, a sound, a GUI display, etc. The output may be provided within the line of sight of the donor 102. In at least one exemplary embodiment, one side of the blood component separation system 200 may include an output 1724, such as Figure 17B For example, output 1724 may include a series of lights such as LEDs. Although output 1724 is shown on a particular side of blood component separation system 200, it should be understood that output 1724 may be on any side of blood component separation system 200 and may be within range of donor 102, such that the output may be one or more of visible and audible to donor 102.

[0428] In at least one exemplary embodiment, output 1724 can be a display device. For example, output 1724 can illuminate or emit light to provide visual information to the donor or other user of the blood component separation system, such as how much time is left in the donation process, whether the donor should squeeze her hand to improve blood flow into the blood component separation system, or other information. Output 1724 can be configured to illuminate or emit light in a pulsed manner, where the rate of light pulses can be synchronized with the rate at which the donor should squeeze her hand to achieve optimal flow rate.

[0429] At step 1709, the method may include determining the percentage of the donation process that has been completed and / or remains. For example, this step may include determining the amount of time remaining in the donation process. Determining the amount of time remaining may include first determining the amount of plasma that donor 102 is expected to donate. Determining the amount of plasma that the donor is expected to donate may include receiving donor information as part of the initiation process. For example, the donor information may be received from the donor's identification card via a reader (such as reader 1221 described above) or a scanner.

[0430] Determining the amount of time remaining can include dividing the amount of plasma the donor is expected to donate by the expected flow rate. For example, if the blood component separation system 200 determines that an expected 1 liter of plasma has not yet been donated, and plasma is expected to be donated at a rate of 1 liter per minute, the blood component separation system 200 can determine that 1 minute remains in the donation process.

[0431] At step 1712, the method may include updating the output in response to detecting the amount of time remaining in the donation process.

[0432] In at least one exemplary embodiment, updating an output, such as output 1724, may include adjusting the number of lights or the percentage of illumination of a display. Figures 17C to 17E As shown, output 1724 can include five lights 1727a to 1727e. Each of the five lights 1727a to 1727e can be illuminated independently based on the remaining time. In addition, as described above, lights 1727a to 1727e can be pulsed, that is, the brightness of each light can be adjusted independently, thereby achieving a pulse effect.

[0433] like Figure 17C As shown, each light of output 1724 can be turned off or otherwise not illuminated to indicate to the donor that the donation process has just begun. Figure 17D As shown, one or more of the lights 1727a to 1727e may 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 illuminated. Figure 17E As shown, each light of output 1724 can be illuminated to indicate to the donor that the donation process has been completed or is nearly complete. In at least one exemplary embodiment, the color of lights 1727a to 1727e of output 1724 can change when the donation process is complete.

[0434] At step 1715, the method may include detecting a pressure loss. Detecting a pressure loss may include detecting a drop in the pressure of the fluid in the blood component separation machine 200 below a predetermined threshold. The pressure loss may be due to poor blood circulation in the donor 102, collapsed veins, insufficient pump power, or other reasons. In some cases, the donor 102 may be required to squeeze her hand to increase the flow rate into the blood component separation system 200. By squeezing her hand at a specific rate, the donor 102 can control the flow rate into the blood component separation system 200.

[0435] At step 1718, in response to detecting a loss of pressure, the method may include updating output 1724. For example, in response to detecting a loss of pressure, the blood component separation system 200 may update output 1724 so that output 1724 instructs the donor 102 to squeeze. Updating output 1724 to instruct the donor to squeeze may include flashing. For example, one or more of lights 1727a to 1727e may be turned on and off. In at least one exemplary embodiment, the brightness of one or more of lights 1727a to 1727e may be pulsed at a specific rate. The rate of light pulsing or flashing may be based on a specific flow rate required to complete the donation process.

[0436] At step 1721, when the donation is complete, the method can end. In at least one exemplary embodiment, ending the method can include detecting the end of the donation process. Ending the method can include turning off output 1724. For example, after detecting the end of the donation process, the blood component separation system 200 can perform an output routine to indicate to the donor 102 that the donation process is complete. Such an output routine can include one or more of: flashing the lights of output 1724 in a specific sequence, changing the color of the lights of output 1724, generating a noise, or producing some other noticeable output, which can indicate to the donor 102 that the donation process has been completed. After the output routine, the device or system can stop emitting any noise and can turn off any lights.

[0437] In at least one exemplary embodiment, during a donation, the blood component separation system 200 can be configured to detect an alarm event and, in response, issue an alert to a user. For example, during a plasma donation, a processor or microcontroller of a computer system within the blood component separation system 200 can be configured to detect factors such as temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors. If any of these factors are incorrect, too high, too low, etc., the processor can generate a graphical output that can alert the user to the alarm event and / or instruct the user on how to resolve the alarm event.

[0438] Detecting alarm events associated with the blood component separation 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.

[0439] Detecting an alarm event may include receiving data from one or more sensors, such as a temperature sensor, a pressure sensor, a flow rate sensor, a color sensor, a valve sensor, a weight sensor, a scanner, or other device.

[0440] Sensors may be positioned throughout the blood component separation system 200 and may be configured to monitor various aspects of the donation process, such as the weight of the plasma donation bottle, the flow rate and pressure of the tubing, the speed of the centrifuge, and / or other elements.

[0441] An alarm event might be detected when one of these factors exceeds a threshold or reaches a specific value. This threshold can be an upper or lower threshold, or it can be a specific amount or a specific range. For example, if the alarm is related to fluid color, the threshold could be a specific color or a specific range of colors.

[0442] The threshold value may also be associated with a time or time range. For example, an alarm event may be detected when data received from the scanner (such as donor identification data) is outdated or expired. In at least one exemplary embodiment, an alarm event may be detected when data received from the scanner indicates one or more of an expired instrument or device, an invalid instrument or device, and an incompatible instrument or device.

[0443] In at least one exemplary embodiment, an alarm event may be based on data from multiple sensors. For example, an alarm event may occur when both pressure and temperature exceed certain thresholds.

[0444] After detecting an alarm, the processor may generate or retrieve a graphical presentation output based on the detected alarm event.

[0445] 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 a user how to resolve the alarm.

[0446] Retrieving the graphical presentation output may include extracting from memory one or more text describing the alarm event, one or more images describing the alarm event, and / or other content intended to instruct a user how to resolve the alarm.

[0447] The instructions include at least one instruction to move the blood component separation system 200 from the alarm state to the operational state. The instructions to move the blood component separation system 200 from the alarm state to the operational state may include visual aids and / or text informing the user of steps to perform to resolve the issue underlying the alarm event. For example, the instructions may include information instructing the user to perform one or more of connecting tubing, closing a latch, and removing a kink from the tubing. In at least one exemplary embodiment, the instructions may include instructing the user to end the donation process and disconnect the donor from the blood component separation system 200.

[0448] After generating and / or retrieving the graphical presentation output based on the detected alarm event, the processor may render the graphical presentation output onto a graphical user interface of the blood component separation system.

[0449] In at least one exemplary embodiment, the processor may additionally or alternatively render the graphical presentation output to a GUI, such as Figure 12B 1230; illuminate one or more LEDs; and / or output an audible sound when an alarm event is detected. The LEDs can switch between multiple colors, such as orange, yellow, red, and cyan. The color of the LED can be selected by the processor to correspond to the type of alarm event detected. In at least one exemplary embodiment, the LEDs can include one or more lights 2339, as will be described below with reference to FIG. Figure 22C discussed.

[0450] In at least one exemplary embodiment, each color can be associated with a different type and / or level of alarm. For example, the type of alarm can indicate that the alarm is associated with one or more of temperature, pressure, flow rate, color, and weight.

[0451] For example, the level of an alarm can indicate the severity of the alarm or the priority of the alarm. In at least one exemplary embodiment, different thresholds can be used to determine whether a particular factor is at a mild or severe level. For example, if the normal pressure is 10 pounds per square inch (PSI), a mild alarm can be set to a pressure below 5 PSI and a severe alarm can be set to a pressure of zero PSI. In at least one exemplary embodiment, a high severity alarm can be red. In at least one exemplary embodiment, a medium priority alarm can be yellow or orange. In at least one exemplary embodiment, a low priority alarm can be green or blue. In at least one exemplary embodiment, if no alarm event is currently detected, the light can be turned off or not illuminated.

[0452] In at least one exemplary embodiment, the severity or priority of an alarm can be indicated by the flashing or blinking of a light. The rate at which the light flashes can also indicate the severity of the alarm. For example, a light flashing at a faster speed or a faster cadence can indicate a higher severity and priority, while a light flashing at a slower speed or a slower cadence can indicate a lower priority.

[0453] In at least one exemplary embodiment, an audible alarm or sound can indicate the severity or priority of an alarm event. For example, various sounds, sound patterns, and sound frequencies can indicate priority. For example, a higher frequency sound can indicate a higher priority alarm event, and a lower frequency sound can indicate a lower priority alarm event. In at least one exemplary embodiment, the rate at which the sound is emitted can indicate the severity of the alarm event. For example, a sound (such as a beep) that occurs more frequently over a period of time can indicate a higher priority alarm event.

[0454] The color of the alarm can be set according to the type of alarm and the severity. For example, a temperature-related alarm can be blue, and the brightness or shade of the color can be adjusted according to the severity of the alarm.

[0455] In at least one exemplary embodiment, the graphical presentation output may include a timestamp indicating when the alarm event occurred.

[0456] In at least one exemplary embodiment, the graphical presentation may include a description of the alert and a list of actions to resolve the alert.

[0457] In at least one exemplary embodiment, the graphical presentation output may include an illustration associated with the alarm event. For example, a photo or illustration may be displayed to instruct the user how to resolve the alarm state.

[0458] In at least one exemplary embodiment, the graphical presentation includes a GUI element that enables a user to perform one or more of resetting the donation process, continuing the donation process, and ending the donation process.

[0459] In at least one exemplary embodiment, after rendering the graphical presentation output, the method may include performing a system check. In at least one exemplary embodiment, the system check may be performed continuously during the donation process. Performing the system check may include polling data associated with the alarm event to determine whether the factor that caused the alarm event has returned to a normal level. If the factor that caused the alarm event has returned to a normal level, the alarm may be resolved and ended. In at least one exemplary embodiment, the alarm event may require ending the donation process and disconnecting the donor from the blood component separation system 200. In these embodiments, the system check may determine that the alarm event may be unresolvable or unrecoverable, and may trigger an alarm and / or provide instructions to end the donation process and disconnect the donor 102.

[0460] For example, if the temperature drops below a predetermined threshold causing an alarm event, performing a system check may include determining whether the temperature is at the predetermined threshold or whether the temperature is above the predetermined threshold.

[0461] At least one exemplary embodiment includes a method comprising: detecting the start of a donation process; providing an output in response to detecting the start of the donation process; determining an amount of time remaining in the donation process; updating the output in response to detecting the amount of time remaining in the donation process; detecting a loss of pressure; updating the output in response to detecting the loss of pressure; detecting the end of the donation process; and updating the output in response to detecting the end of the donation process.

[0462] Aspects of the above embodiment include: the donation process is a plasma donation using a blood component separation machine. Aspects of the above embodiment include: detecting the start of the donation process includes detecting fluid flow. Aspects of the above embodiment include: the output is one or more of light and sound. Aspects of the above embodiment include: the output is located on a side of the blood component separation machine. Aspects of the above embodiment include: the output is within range of the donor. Aspects of the above embodiment include: the output can be one or more of visible and audible to the donor. Aspects of the above embodiment include: the output is a display device. Aspects of the above embodiment include: the display device displays a series of lights. Aspects of the above embodiment include: the series of lights updates to indicate to the donor the amount of time remaining in the donation process. Aspects of the above embodiment include: the series of lights pulses to instruct the donor to squeeze. Aspects of the above embodiment include: the light pulses have a rhythm associated with the rate at which the donor should squeeze to maintain pressure. Aspects of the above embodiment include: detecting a loss of pressure includes detecting a drop in pressure of the fluid in the blood component separation machine below a predetermined threshold. Aspects of the above embodiment include: updating the output in response to detecting a loss of pressure includes instructing the donor to squeeze. Aspects of the above embodiments include that in response to detecting the end of the donation process, updating the output includes stopping the audible noise or turning off a light.

[0463] At least one exemplary embodiment of the present disclosure includes a method comprising detecting an alarm event associated with a blood component separation 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 blood component separation system.

[0464] Aspects of the above method include: the method is performed by a blood component separation system for performing a plasma donation process. Aspects of the above method include: the alarm event is associated with one or more of the following factors: temperature, pressure, flow rate, fluid color, receipt of an excess of plasma, and data received from a scanner. Aspects of the above method include: the alarm event is associated with expired data received from the scanner. Aspects of the above method include: detecting the alarm event when one of the above factors exceeds a threshold. Aspects of the above method include: detecting the alarm event includes receiving data from one or more sensors. Aspects of the above method include: retrieving a graphical presentation output includes generating a graphical presentation output. Aspects of the above method include: the graphical presentation output includes instructions describing the alarm event. Aspects of the above method include: the instructions include at least one instruction to move the blood component separation system from an alarm state to an operational state. Aspects of the above method include: the instructions include instructing a user to perform one or more of connecting tubing, closing a latch, and removing a kink from the tubing. Aspects of the above method include: illuminating an LED when the alarm event is detected. Aspects of the above method include: the processor selecting the color of the LED to correspond to the type of alarm event detected; wherein the color is selected from orange, yellow, red and cyan; and the type of alarm 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: performing the system check includes polling data associated with the alarm event. Aspects of the above method include: the graphical presentation output includes a timestamp indicating the time when the alarm event occurred. Aspects of the above method include: the graphical presentation output includes an icon associated with the alarm event. Aspects of the above method include: the icon instructs the user to resolve the alarm state. Aspects of the above method include: the graphical presentation includes a description of the alarm and a list of actions to resolve the alarm. Aspects of the above method include: the graphical presentation includes a GUI element that enables the user to perform one or more of resetting the donation process, continuing the donation process and ending the donation process.

[0465] Exemplary Modular Repairable Sleds and Interconnects

[0466] In at least one exemplary embodiment, a blood component separation system (e.g., blood component separation system 200 or blood component separation system 1800) includes one or more subsystems (e.g., a power subassembly, a pneumatic control subassembly, a communication subassembly, pumps 208, 212, 216, a bottle tray load cell assembly 1500, etc.) that are attached to a carriage or mechanical frame that can be completely separated from the blood component separation system for service, maintenance, and / or replacement. The modular serviceable carriage can include one or more mechanical and / or electrical interconnects that can be selectively decoupled from corresponding one or more mechanical and / or electrical interconnects of the blood component separation system. Once decoupled, the entire subsystem on a particular modular serviceable carriage can be removed from the blood component separation system, e.g., the entire subsystem is independent of the other subsystems and the modular serviceable carriage.

[0467] In at least one exemplary embodiment, the modular serviceable carriage can be divided into discrete and / or grouped subsystem carriages. For example, one modular serviceable carriage can include multiple pneumatic systems (e.g., two or more manifolds, valves, etc.) for a blood component separation system, another modular serviceable carriage can include multiple electrical systems (e.g., two or more processors, controllers, memory devices, power supplies, wiring harnesses, connectors, etc.), and / or other modular serviceable carriages can include electrical and / or mechanical subsystems grouped together based on predicted and / or historical service requirements.

[0468] In at least one exemplary embodiment, pumps 208, 212, 216 (e.g., Figure 2A One or more pumps in a modular serviceable carriage (e.g., shown) can be quickly replaced by removing a limited number of fasteners (e.g., screws, bolts, nuts, etc.) associated with the corresponding modular serviceable carriage. After removing the one or more fasteners, the entire corresponding modular serviceable carriage and associated systems (e.g., pumps 208, 212, 216) can be removed from the blood component separation system without disassembling the blood component separation system and / or removing other panels, frames, etc.

[0469] In addition, these modular serviceable slides can enable components to be quickly separated from the blood component separation system and maintained separately from the blood component separation system. In at least one exemplary embodiment, once a modular serviceable slide has been removed from the blood component separation system, a different (e.g., new, refurbished, etc.) modular serviceable slide can be replaced in the blood component separation system, and the blood component separation system can continue to operate (e.g., when the removed modular serviceable slide is being repaired, returned to manufacturing, or repaired / reworked). This approach can achieve minute-level replacement of subsystems, particularly increasing the operability of the blood component separation system and reducing its downtime, while other blood component separation systems may require hours or more for maintenance.

[0470] Figure 18A is a partially exploded perspective view of a blood component separation system including a modular serviceable carriage according to at least one exemplary embodiment.

[0471] In at least one exemplary embodiment, Figure 18A As shown, the blood component separation system 1800 includes one or more modular serviceable carriages 1802. The blood component separation system 1800 may be similar to Figure 1

[0065] Blood component separation system 200 in Figure A. At least in the exemplary embodiment shown, carriage 1802 includes a first carriage 1802A, a second carriage 1802B, a third carriage 1802C, a fourth carriage 1802D, a fifth carriage 1802E, a sixth carriage 1802F, a seventh carriage 1802G, an eighth carriage 1802H, and a ninth carriage 1802I (collectively, "carriages 1802"). Blood component separation system 1800 may also include a base assembly 1804. Base assembly 1804 may define a plurality of receiving spaces 1806. Receiving spaces 1806 may be defined in any surface (or surfaces) of base assembly 1804, including a top surface, a side surface, and / or a rear surface, among others. Each carriage in carriage 1802 may be at least partially located within one of receiving spaces 1806. Each of the carriages 1802 can include a modular frame configured to selectively engage a blood component separation system, as will be described in greater detail below.

[0472] In at least one exemplary embodiment, base assembly 1804 includes a housing 1804A and a frame 1804B. Housing 1804A can include plastic and frame 1804B can include metal. In at least one other exemplary embodiment, base assembly 1804 can include a unitary housing and frame. In at least one exemplary embodiment, housing 1804A can include angled or contoured regions 1807 at the periphery of some or all of receiving spaces 1806. An angled or contoured region 1807 can be configured to direct fluid away from carriage 1802 (e.g., gasket 1818 of carriage 1802) to reduce or prevent fluid accumulation near gasket 1818 and / or to facilitate cleaning of housing 1804A.

[0473] In at least one exemplary embodiment, the first modular serviceable sled 1802A includes a suction pump. The suction pump may be used with Figure 2A The suction pump 208 in the embodiment of the present invention is similar or identical to the suction pump 208 in the embodiment of the present invention. The suction pump can be configured to have an electrical connection, an electrical communication connection, and a pneumatic connection with the base assembly 1804. The first modular serviceable sled 1802A can have an environmental or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0474] In at least one exemplary embodiment, the second modular serviceable sled 1802B includes a return pump. The return pump may be used with Figure 2A The return pump 212 in the second modular serviceable carriage 1802B may be similar or identical to the return pump 212 in the second modular serviceable carriage 1802B. The return pump may be configured to have electrical, electrical, and pneumatic connections to the base assembly 1804. The second modular serviceable carriage 1802B may have an environmental or fluid gasket and a shielding member configured to engage with the base assembly 1804.

[0475] In at least one exemplary embodiment, the third modular serviceable sled 1802C includes an AC pump. The AC pump may be connected to Figure 2A The AC pump 216 in FIG. 1802A can be similar or identical to the AC pump 216 in FIG. 1802B. The AC pump can be configured to have an electrical power connection and an electrical communication connection with the base assembly 1804. The third modular serviceable sled 1802C can have an environmental or fluid gasket and a shielding member configured to engage with the base assembly 1804.

[0476] In at least one exemplary embodiment, fourth carriage 1802D includes a fluid valve control system. The fluid valve control system can be connected to Figure 2A The fluid valve control system 228 in FIG. 10 can be similar or identical to the fluid valve control system 228 in FIG. The fluid valve control system can be configured to have electrical, electrical communication, and pneumatic connections with the base assembly 1804. The fourth modular serviceable carriage 1802D can have an environmental or fluid gasket and a shielding member configured to engage with the base assembly 1804.

[0477] In at least one exemplary embodiment, the fifth carriage 1802E includes a bottle pallet load cell assembly. The bottle pallet load cell assembly can be used with Figures 15A to 15M The bottle tray load cell assembly can be similar or identical to the load cell assembly 1500 in FIG. The bottle tray load cell assembly...

Claims

1. A method comprising: Detect the activation of the blood component separation machine; responsive to detecting the activation, transmitting data to a server; Based on the data, determining whether the software of the blood component separation machine is a current version; receiving a response from the server in response to the data; as well as If the response indicates that the software is not a current version, use of the apheresis machine is prevented.

2. The method according to claim 1, wherein The data transmitted to the server includes one or more of the following: a data log, a firmware version identifier, and an error log.

3. The method according to claim 1, wherein The response includes a lock signal.

4. The method according to claim 1, wherein The response includes a software update.

5. The method according to claim 4, wherein The software update includes a firmware update.

6. The method according to claim 4, further comprising: The installation of the software update is automatically initiated.

7. The method according to claim 6, further comprising: After the software update is installed, use of the apheresis machine is unblocked.

8. The method according to claim 4, further comprising: Manually initiate the installation of the software update.

9. The method according to claim 1, further comprising: Based on the response from the server, a message is displayed on a graphical user interface.

10. The method according to claim 9, wherein: The graphical user interface enables a user to initiate software installation.

11. The method according to claim 1 , further comprising: After preventing use of the blood component separation machine, determining that unlocking requirements have been met; as well as In response to determining that the unlock requirement has been met, use of the blood component separation machine is enabled.

12. The method according to claim 11, wherein The unlocking requirement is associated with the updated software.

13. The method according to claim 1, wherein The software includes one or more of the following: firmware, applications, and operating systems.

14. The method according to claim 1, further comprising: Manually install software updates.

15. The method according to claim 14, wherein The manually installing the software update includes connecting an external device including the software update to the apheresis machine and installing the software update.

Images