Method for providing automatic flow regulation

Abstract

A method includes: activating one or more pumps of a blood component separation machine; detecting a flow rate of the fluid through the blood component separation machine; detecting that the flow of the fluid is lower than a preset threshold value; and in response to detecting that the flow rate of the fluid is below the predetermined threshold, adjusting a rate of one or more pumps of the blood component separation machine.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Patent Application No. 18 / 116,992, filed March 3, 2023, which claims priority to U.S. Provisional Application No. 63 / 318,703, filed March 10, 2022. The entire contents of the above applications are incorporated herein by reference. TECHNICAL FIELD

[0003] The present disclosure relates to methods of providing automatic flow regulation, in particular, methods of providing automatic flow regulation in a blood component separation system. BACKGROUND

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

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

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

[0007] A system for plasma or other blood component donation that can reduce donation time and improve donor comfort is needed. 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 into the donor without stopping and restarting the centrifuge. For example, in at least one example embodiment, the present disclosure provides a method and apparatus for positioning a portion of a disposable set (including, for example, a circuit) in a medical device. In at least one example embodiment, the present disclosure provides a system, for example including a surface, for automatically guiding a circuit. In at least one example embodiment, the present disclosure provides a medical device, for example including a blood component separation machine, such as a blood separation machine.

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

[0009] In at least one example embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly can 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 can include a fluid separation body at least partially disposed within the inner cavity of the centrifuge housing. The fluid separation body can be configured to rotate about the rotational axis of the centrifuge assembly relative to the centrifuge housing. The centrifuge assembly can include a fluid line loop arm attached to a portion of the centrifuge housing and extending along a length of the outer surface of the centrifuge housing. The fluid line loop arm can include a bearing set disposed at a point along the length of the outer surface, wherein the bearing set is configured to contact a tubing portion of an interconnected fluid line loop and hold the fluid line loop in an engaged position relative to the centrifuge housing while allowing the fluid line loop to rotate in the engaged position. In at least one example embodiment, the bearing set can include a pair of roller bearings. In at least one example embodiment, the bearing set can include a plurality of pairs of roller bearings. In at least one example embodiment, the centrifuge assembly can be part of a blood component separation machine. In at least one example embodiment, the fluid line loop can be secured to a static non-rotating portion of the blood component separation machine at a first end of the fluid line loop by a first positively located connector, the fluid line loop can be interconnected with the fluid separation body within the inner cavity at a second end of the fluid line loop by a second positively located connector. In at least one example embodiment, the second end of the fluid line loop can rotate with the fluid separation body. In at least one example embodiment, the fluid line loop can be physically and fluidically attached to a disposable fluid separation pod at the second positively located connector. In at least one example embodiment, the fluid line loop can include a plurality of lumen. In at least one example embodiment, the fluid separation pod can include a first flexible sheet material attached to a second flexible sheet material 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 example embodiment, the present disclosure provides a method of automatically loading a fluid line circuit into a centrifuge assembly. The method can include attaching a first end of the fluid line circuit to a fluid separation body of the centrifuge assembly, and rotating the fluid separation body relative to a housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separation body can cause the fluid line circuit to rotate relative to the housing and cause the fluid line circuit to be guided into a channel of a circuit arm attached to a portion of the housing. The channel can include a bearing disposed in a set of bearings attached to the circuit arm. The bearing can maintain the fluid line circuit in a position relative to the housing as the centrifuge assembly rotates. In at least one example embodiment, the bearing can contact a portion of the fluid line circuit as the fluid line circuit rotates in the position relative to the housing within the channel. In at least one example embodiment, the centrifuge housing can rotate about an axis of rotation in the first rotational direction at a first angular velocity, and the fluid separation body can rotate about the axis of rotation at a different second angular velocity by a torsional force provided by the fluid line circuit. In at least one example embodiment, the second angular velocity can be approximately twice the first angular velocity. In at least one example embodiment, the fluid line circuit can be physically and fluidically attached to a disposable fluid separation pod at least partially disposed within the fluid separation body. In at least one example embodiment, the method can further include attaching a second end of the fluid line circuit to a rotational fixed point of a blood component separation machine, and rotating the centrifuge assembly about the axis of rotation relative to the rotational fixed point of the blood component separation machine (e.g., by a rotor and motor assembly of the blood component separation machine).

[0011] In at least one example embodiment, the present disclosure provides a method of collecting blood components by blood component separation. The method can include drawing whole blood of a donor into a centrifuge; rotating the centrifuge to cause a centrifugal force to act on the whole blood to separate the whole blood into at least a first blood component and a third blood component; separating the first blood component from the whole blood; extracting the first blood component into a container; detecting when a second blood component is extracted; after detecting the second blood component, forcing the separated first blood component back toward the centrifuge while the centrifuge continues to rotate to at least remove the third blood component from the centrifuge and back to the donor. In at least one example embodiment, the first blood component can include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one example embodiment, the second blood component can include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one example embodiment, the third blood component can include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one example embodiment, the first blood component can include two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one example embodiment, the centrifuge can rotate at a first speed when separating the first blood component from the whole blood. In at least one example embodiment, the centrifuge can continue to rotate at the first speed when forcing the separated first blood component back toward the centrifuge. In at least one example embodiment, the centrifuge can rotate at a second speed when drawing the whole blood of the donor into the centrifuge. In at least one example embodiment, the second speed can include a slower speed than the first speed. In at least one example embodiment, the first blood component can include a blood component separated from the whole blood in a blood component collection device inserted into the centrifuge. In at least one example embodiment, the centrifuge can include a filler that rotates a blood component collection bladder associated with the blood component collection device. In at least one example embodiment, the blood component collection bladder can be inserted into a collection insertion passage formed in the filler to hold the blood component collection bladder.

[0012] In at least one example embodiment, the present disclosure provides a blood component separation system. The blood component separation system can include a first tubing having a lumen associated with a needle fluid that moves whole blood from a donor through the lumen, a suction pump engaged with the first tubing that suctions the whole blood from the donor into a centrifuge, the centrifuge that rotates to cause a centrifugal force to act on the whole blood to separate the whole blood into at least a first blood component and a third blood component, a blood component collection bladder inserted into the centrifuge and fluidly connected with the first tubing and separates the first blood component from the whole blood, a second tubing fluidly associated with the blood collection bladder and moves the first blood component from the blood component collection bladder, a collection container fluidly associated with the second tubing and extracts the first blood component from the blood component separation system, a sensor physically proximate to the second tubing to detect when a second blood component is extracted from the whole blood, upon the sensor detecting the second blood component, a backflow pump engaged with the second tubing forces the separated first blood component to return through the second tubing toward the blood component collection bladder while the centrifuge continues to rotate to at least move the third blood component from the blood component collection bladder and back to the donor. In at least one example embodiment, the first blood component can include plasma, the second blood component can include platelets, red blood cells, and / or high hematocrit blood. In at least one example embodiment, the blood component separation system can further include an anticoagulant pump configured to draw anticoagulant from an anticoagulant bag and mix the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tubing. In at least one example embodiment, the centrifuge can include a filler that rotates the blood component collection bladder. In at least one example embodiment, the blood component collection bladder can be inserted into a collection insertion channel formed in the filler to hold the blood component collection bladder.

[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 example embodiment, the present disclosure provides a fluid separation insert. The fluid separation insert can include a body having an axis of rotation substantially disposed at a center of mass of the body and a fluid collection insert channel disposed in the body and following a generally helical path that extends helically outward from a first point proximate the axis of rotation to a second point proximate a perimeter of the body. The fluid collection insert channel can be offset outward toward the perimeter of the body near an end of the generally helical path, the generally helical path defining a third point of the fluid collection insert channel disposed furthest from the axis of rotation. In at least one example embodiment, the fluid separation insert can further include a fluid collection chamber disposed within the body and following a portion of the generally helical path, wherein the fluid collection insert 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 example embodiment, the fluid collection chamber can be configured to receive a disposable fluid collection bladder. In at least one example embodiment, a dimension from the axis of rotation to the third point of the generally helical path can be greater than a dimension from the axis of rotation to the second point of the generally helical path. In at least one example embodiment, a width of the fluid collection chamber at a point along the generally helical path can be greater than a width of the fluid collection insert channel at the point along the generally helical path. In at least one example embodiment, the fluid collection chamber can further include a first wall following an innermost portion of the generally helical path and a second wall substantially parallel to the first wall and following an outermost portion of the generally helical path. In at least one example 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 to an in-place position within the fluid collection chamber. In at least one example embodiment, when the disposable fluid collection bladder is installed in the fluid collection chamber, a fluid inlet of the disposable fluid collection bladder can be disposed proximate the axis of rotation, a first fluid path in the disposable fluid collection bladder can follow the generally helical path outward toward an end of the disposable fluid collection bladder disposed proximate the third point of the fluid collection insert channel furthest 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 traveling in a direction following the generally helical path inward toward a fluid outlet of the disposable fluid collection bladder disposed proximate the axis of rotation from the third point. In at least one example embodiment, the fluid inlet and the fluid outlet can be part of a connector attached to the disposable fluid collection bladder, and the body of the fluid separation insert can include a connection point to engage the connector. In at least one example 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 example embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly can include a centrifuge housing having an internal 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 internal cavity of the centrifuge housing and is configured to rotate about the rotational axis relative to the centrifuge housing. The fluid separation body can include a fluid collection insert channel disposed in the fluid separation body that follows a generally helical path extending outwardly from a first point proximate the rotational axis to a second point disposed proximate a periphery of the fluid separation body. In at least one example embodiment, the fluid collection insert channel can be, the fluid separation body can further include a fluid collection chamber disposed within the body and following a portion of the generally helical path, wherein the fluid collection insert channel can be connected to the fluid collection chamber to define an access region between an interior of the fluid collection chamber and an exterior of the fluid separation body. In at least one example embodiment, the centrifuge assembly can further include a disposable fluid collection bladder disposed within the fluid collection chamber following the generally helical path. The disposable fluid collection bladder can include a fluid inlet disposed proximate the rotational axis, a first fluid path in the disposable fluid collection bladder can follow the generally helical path outwardly toward an end of the disposable fluid collection bladder disposed proximate a third point of the fluid collection insert channel furthest from the rotational axis, and can be fluidly interconnected with a second fluid path in the disposable fluid collection bladder separate from the first fluid path that travels in a direction following the generally helical path inwardly toward a fluid outlet of the disposable fluid collection bladder disposed proximate the rotational axis. In at least one example embodiment, the centrifuge assembly can be part of a blood component separation machine. In at least one example embodiment, the centrifuge housing can be divided into an upper housing and a lower housing, wherein the upper housing can include the internal cavity, the upper housing can be rotatable about a pivot axis offset from and substantially perpendicular to the rotational axis between an open state and a closed state, and the fluid collection insert channel of the fluid separation body is accessible in the open state and inaccessible in the closed state.

[0017] In at least one example embodiment, the present disclosure provides a blood component collection circuit. The blood component collection circuit can 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 stationary 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 area of a filler, wherein a torsional force based on a twist in the flexible circuit is applied to the filler through the filler circuit connector, wherein the flexible circuit rotational movement is captured by a circuit rotational position guide positioned on the centrifuge. In at least one example embodiment, the blood component collection circuit can be part of a blood component collection device, and the blood component collection device can be associated with a blood component separation system. In at least one example embodiment, the circuit rotational position guide can be attached to a rotor that rotates the circuit rotational position guide and the flexible circuit about an axis of rotation. In at least one example embodiment, the blood component collection circuit can be at least partially positioned by a circuit position stop plate. In at least one example embodiment, the flexible circuit can be bent around the centrifuge. In at least one example embodiment, the flexible circuit can also be held in place by a circuit containment cradle. In at least one example embodiment, at least a portion of the circuit rotational position guide can include a circuit torsion support bearing. In at least one example embodiment, the circuit torsion support bearing can include a pair of roller bearings. In at least one example embodiment, the circuit torsion support bearing can allow the flexible circuit to twist. In at least one example embodiment, the twist can cause the filler to rotate at a greater angular velocity than the centrifuge. In at least one example 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 example embodiment, the present disclosure provides an assembly to load a flexible circuit. The assembly can include a circuit rotational position guide comprising a channel to hold a flexible circuit of a blood component collection set; a circuit twist support bearing disposed in the channel and on a portion of the circuit rotational position guide to support the flexible circuit; and a circuit capture arm, wherein the circuit capture arm can be positioned adjacent to the channel and connected to the circuit rotational position guide to guide the flexible circuit into the channel and into contact with the circuit twist support bearing. In at least one example embodiment, the assembly can be part of a blood component separation machine, the circuit rotational position guide can be attached to a centrifuge that rotates the circuit rotational position guide and the flexible circuit about a rotational axis. In at least one example embodiment, the circuit rotational position guide can further include a circuit position stop plate to further position the flexible circuit. In at least one example embodiment, the assembly can further include a circuit containment cradle in the same plane as the circuit rotational position guide and disposed on the centrifuge to further capture the flexible circuit.

[0019] In at least one example embodiment, the present disclosure provides a method to automatically load a flexible circuit into an assembly. The method can 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 a filler, wherein a twist force based on a twist in the flexible circuit is applied to the filler through the filler circuit connector; and rotating the flexible circuit into a circuit rotational position guide disposed on the centrifuge. In at least one example embodiment, the flexible circuit can engage a circuit twist support bearing disposed in a channel formed by the circuit rotational position guide, wherein the circuit twist support bearing supports the flexible circuit. In at least one example embodiment, a circuit capture arm can contact the flexible circuit as it rotates to guide the flexible circuit into the channel and into contact with the circuit twist support bearing. In at least one example embodiment, the circuit rotational position guide can further include a circuit position stop plate to prevent over-rotation of the flexible circuit through the channel. In at least one example embodiment, a circuit containment cradle in the same plane as the circuit rotational position guide and disposed on the centrifuge can further capture and hold the flexible circuit.

[0020] In at least one example embodiment, the present disclosure provides a soft cassette. The soft cassette can include a first cassette port; a second cassette port; a straight-through lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber disposed in the straight-through lumen such that fluid passing through the straight-through lumen passes through the drip chamber; and a fluid flow bypass path fluidly connected to the straight-through lumen proximate the first cassette port and between the first cassette port and the drip chamber and fluidly connected to the straight-through lumen proximate the second cassette port and between the second cassette port and the drip chamber such that fluid passing through the fluid flow bypass path bypasses the drip chamber. In at least one example embodiment, the fluid flow bypass path can include a first bypass branch fluidly connected to the straight-through lumen proximate the first cassette port and a second bypass branch fluidly connected to the straight-through lumen proximate the second cassette port. In at least one example embodiment, the fluid flow bypass path can further include a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch. In at least one example embodiment, the straight-through lumen can include a first compliance region disposed between a first connection to the first bypass branch and the drip chamber, allowing a first fluid control valve to occlude the straight-through lumen. In at least one example embodiment, the straight-through lumen can include a second compliance region disposed between a second connection to the second bypass branch and the drip chamber, allowing a second fluid control valve to occlude the straight-through lumen. In at least one example embodiment, the straight-through lumen can include a third compliance region disposed in the first bypass branch, allowing an aspiration fluid control valve to occlude the first bypass branch. In at least one example embodiment, the first cassette port can be fluidly connected to a cassette inlet tube that moves fluid from a donor into the soft cassette or moves fluid from the soft cassette to the donor, and the second cassette port can be fluidly connected to a circuit inlet tube that moves fluid from the soft cassette into a centrifuge or moves fluid from the centrifuge to the soft cassette. In at least one example embodiment, when fluid is aspirated from the donor, the fluid can pass through the fluid flow bypass path. In at least one example embodiment, when fluid is sent back to the donor, the fluid can pass through the straight-through lumen. In at least one example embodiment, when fluid is aspirated from the donor in a subsequent aspiration, a portion of the fluid previously delivered to the donor through the straight-through lumen can remain in the drip chamber when fluid passes through the fluid flow bypass path. In at least one example embodiment, the soft cassette can be part of a blood component collection device. In at least one example embodiment, the blood component collection device can be part of a blood component separation system.

[0021] In at least one example embodiment, the present disclosure provides a blood component collection device. The blood component collection device can include a centrifuge to separate a blood component from whole blood; a cassette inlet tube in fluid connection with a donor; a circuit inlet tube in fluid connection with the centrifuge; a soft cassette including a first cassette port fluidly connected to the cassette inlet tube; a second cassette port fluidly connected to the circuit inlet tube; a straight flow lumen in fluid connection with the first cassette port and the second cassette port; a drip chamber disposed in the straight flow lumen such that fluid passing through the straight flow lumen passes through the drip chamber; and a fluid flow bypass path both in fluid connection with the straight flow lumen proximate the first cassette port and between the first cassette port and the drip chamber and in fluid connection with the straight flow lumen proximate the second cassette port and between the second cassette port and the drip chamber such that fluid passing through the fluid flow bypass path bypasses the drip chamber. In at least one example embodiment, the fluid flow bypass path can include a first bypass branch in fluid connection with the straight flow lumen proximate the first cassette port, a second bypass branch in fluid connection with the straight flow lumen proximate the second cassette port, and a fluid pressure ring disposed between and in fluid connection with the first bypass branch and the second bypass branch. In at least one example embodiment, the straight flow lumen can include a first compliance region disposed between a first junction in connection with the first bypass branch and the drip chamber, allowing a first fluid control valve to occlude the straight flow lumen, wherein the straight flow lumen includes a second compliance region disposed between a second junction in connection with the second bypass branch and the drip chamber, allowing a second fluid control valve to occlude the straight flow lumen, wherein the straight flow lumen includes a third compliance region disposed in the first bypass branch, allowing an aspiration fluid control valve to occlude the first bypass branch. In at least one example embodiment, when fluid is being aspirated from the donor, the first fluid control valve and the second fluid flow control valve can be closed and occlude the straight flow lumen, the aspiration fluid control valve can be open and allow whole blood to pass through the fluid flow bypass path. In at least one example embodiment, when fluid is being sent back to the donor, the first fluid control valve and the second fluid flow control valve can be open and allow fluid to pass through the straight flow lumen, the aspiration fluid control valve can be closed and occlude the fluid flow bypass path. In at least one example embodiment, when fluid is being aspirated from the donor in a subsequent aspiration, a portion of the fluid previously delivered to the donor through the straight flow lumen can be retained in the drip chamber when fluid passes through the fluid flow bypass path.

[0022] In at least one example embodiment, the present disclosure provides a method of moving fluid through a soft cassette. The method can include providing a soft cassette, wherein the soft cassette includes a first cassette port fluidly connected to a cassette inlet tube; a second cassette port fluidly connected to a circuit inlet tube; a straight-through lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber disposed in the straight-through lumen such that fluid passing through the straight-through lumen passes through the drip chamber; and a fluid flow bypass path fluidly connected to the straight-through lumen proximate the first cassette port and between the first cassette port and the drip chamber and fluidly connected to the straight-through lumen proximate the second cassette port and between the second cassette port and the drip chamber, such that fluid passing through the fluid flow bypass path bypasses the drip chamber. In at least one example embodiment, the method can include, when whole blood is drawn from a donor, receiving the whole blood from the cassette inlet tube at the first cassette port fluidly connected to the cassette inlet tube, moving the whole blood through the fluid flow bypass path to the second cassette port, and preventing the whole blood from moving through the straight-through lumen. In at least one example embodiment, the method can include, when red blood cells are returned to the donor, receiving the red blood cells from the circuit inlet tube at the second cassette port fluidly connected to the circuit inlet tube, moving the red blood cells through the straight-through lumen and the drip chamber to the first cassette port, and preventing the red blood cells from moving through the fluid flow bypass path. In at least one example embodiment, when fluid is drawn from the donor in a subsequent draw, a portion of the fluid from a previous draw can be returned to the donor through the straight-through lumen, and the same is true when red blood cells are returned to the donor.

[0023] The present disclosure also describes a method of automatically adjusting fluid flow. In at least one example embodiment, the method can include activating one or more pumps of a blood component separation machine; detecting a flow rate of a fluid through the blood component separation machine; detecting that the flow rate of the fluid is below a predetermined threshold; and in response to detecting that the flow rate of the fluid is below the predetermined threshold, adjusting a rate of the one or more pumps of the blood component separation machine.

[0024] In at least one example embodiment, detecting that the flow rate of the fluid is below the predetermined threshold can include detecting a collapsed vein.

[0025] In at least one example embodiment, detecting that the flow rate of the fluid is below the predetermined threshold can include detecting a color of the fluid using a sensor. In at least one example embodiment, the sensor can detect one or more of a red color, a blue color, or a green color.

[0026] In at least one example embodiment, detecting that the flow rate of the fluid is below the predetermined threshold can include detecting a flow rate of the fluid using a sensor.

[0027] In at least one example embodiment, detecting that the flow rate of the fluid is below a predetermined threshold can include detecting a pressure of the fluid flow using a sensor.

[0028] In at least one example embodiment, detecting that the flow rate of the fluid is below a predetermined threshold can include detecting a temperature of the fluid using a sensor.

[0029] In at least one example embodiment, adjusting a rate of one or more pumps of the blood component separation machine can include sending a control signal to the one or more pumps.

[0030] In at least one example embodiment, adjusting a rate of one or more pumps of the blood component separation machine can include changing a power applied to the one or more pumps.

[0031] In at least one example embodiment, adjusting a rate of one or more pumps of the blood component separation machine can include turning off the one or more pumps.

[0032] According to certain aspects, embodiments, and / or configurations, the present disclosure provides a number of advantages. For example, in at least one example embodiment, by adjusting the rotational speed of the centrifuge during the process of sending unwanted blood components back to the donor, the time of the blood component separation process can be shortened, e.g., by about 30% or more. This increase in efficiency can make the donation faster and more comfortable. With the shortened donation time, a donation center can obtain more donations in a typical day, which can increase productivity and revenue. Moreover, if the donation is faster, the donor is more likely to donate again. Faster donations can also enable a donation center to attract donors who otherwise use other donation centers that have slower donation speeds.

[0033] Other suitable applications will become apparent from the description provided herein. The description and specific examples in this summary are intended only to illustrate certain embodiments and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0034] The accompanying drawings illustrated by the present disclosure are only for selected embodiments, not for all possible implementations, and are not intended to limit the scope of the present disclosure.

[0035] Figure 1 shows a perspective view of an operating environment of a blood component separation system according to at least one example embodiment of the present disclosure;

[0036] Figure 2A is Figure 1 a perspective view of a blood component separation system shown in FIG. 1;

[0037] Figure 2Bis 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;

[0038] 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;

[0039] Figure 2D is a detailed perspective view of a fluid valve control system according to at least one exemplary embodiment of the present disclosure;

[0040] Figure 3A is a detailed perspective view of a disposable softbox assembly according to at least one embodiment of the present disclosure;

[0041] Figure 3B is a perspective view of a disposable softbox according to at least one embodiment of the present disclosure;

[0042] 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.

[0043] Figure 3D According to at least one exemplary embodiment of the present disclosure Figure 3B The vertical section view taken by the line 3D;

[0044] 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;

[0045] Figure 4B Shown Figure 4A A front perspective view of the centrifuge assembly shown in ;

[0046] Figure 4C Shown Figure 4A a rear perspective view of the centrifuge assembly shown in ;

[0047] Figure 4D is a schematic cross-sectional view of a centrifuge assembly in a closed state according to at least one exemplary embodiment of the present disclosure;

[0048] 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;

[0049] 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;

[0050] Figure 4Gshows a perspective view of a centrifuge filler according to at least one exemplary embodiment of the present disclosure;

[0051] Figure 4H is a plan view of a centrifuge packing according to at least one exemplary embodiment of the present disclosure;

[0052] 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;

[0053] Figure 4J It is along Figure 4H An elevational sectional view taken along line 4J in FIG.

[0054] 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;

[0055] Figure 4L Shows the settings Figure 4K Different states of the fluid collecting sacs within the channels of the filler;

[0056] 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;

[0057] 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;

[0058] Figure 5C shows a cross-sectional view of a fluid component collection capsule according to at least one exemplary embodiment of the present disclosure;

[0059] Figure 5D shows another cross-sectional view of a fluid component collection capsule according to at least one exemplary embodiment of the present disclosure;

[0060] Figure 5E shows a perspective view of a fluid component collection circuit in a bent state according to at least one exemplary embodiment of the present disclosure;

[0061] 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;

[0062] 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;

[0063] Figure 5HA perspective view of a fluid component collection circuit loaded in a fill is shown in accordance with at least one example embodiment of the present disclosure;

[0064] Figure 6A A schematic cross-sectional view of a centrifuge assembly in a first circuit loading state is shown in accordance with at least one example embodiment of the present disclosure;

[0065] Figure 6B A schematic cross-sectional view of a centrifuge assembly in a second circuit loading state is shown in accordance with at least one example embodiment of the present disclosure;

[0066] Figure 6C A schematic cross-sectional view of a centrifuge assembly in a third circuit loading state is shown in accordance with at least one example embodiment of the present disclosure;

[0067] Figure 7A A schematic plan view of a centrifuge assembly in a circuit loading state is shown in accordance with at least one example embodiment of the present disclosure;

[0068] Figure 7B A schematic plan view of a centrifuge assembly in an operational state is shown in accordance with at least one example embodiment of the present disclosure;

[0069] Figure 8 A functional diagram of an embodiment of a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0070] Figure 9 A block diagram of an electrical system of a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0071] Figure 10 Another block diagram of an electrical system of a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0072] Figure 11 Another block diagram of an electrical system of a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0073] Figure 12A A flow diagram of a method in accordance with at least one example embodiment of the present disclosure;

[0074] Figure 12B A blood component separation system with a scanner is shown in accordance with at least one example embodiment of the present disclosure;

[0075] Figure 12C A bottle is shown in accordance with at least one example embodiment of the present disclosure;

[0076] Figure 12Dshows a graphical user interface according to at least one exemplary embodiment of the present disclosure;

[0077] Figure 13A is an isometric view of a plasma collection vial holder according to at least one exemplary embodiment of the present disclosure;

[0078] Figure 13B is a flow chart according to at least one exemplary embodiment of the present disclosure;

[0079] 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;

[0080] Figure 14B yes Figure 14A A partial view of the mobile loop retainer shown in ;

[0081] Figure 14C It is along Figure 14B An elevational cross-sectional view taken along line 14C as shown in FIG.

[0082] 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;

[0083] 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;

[0084] 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;

[0085] Figure 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment of the present disclosure;

[0086] Figure 15B According to at least one exemplary embodiment of the present disclosure Figure 15A An exploded perspective view of the load cell assembly in FIG.

[0087] 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;

[0088] 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;

[0089] Figure 15Eis a perspective view of a load interface plate of a load cell assembly in Figure 15A

[0090] Figure 15F is a perspective view of a load cell of a load cell assembly in Figure 15A

[0091] Figure 15G is a perspective view of an overload support rod of a load cell assembly in Figure 15A

[0092] Figure 15H is a perspective view of an overload support rod of a load cell assembly in Figure 15A

[0093] Figure 15I is a partial cross-sectional view of a load cell assembly in an engaged state in Figure 15A

[0094] Figure 15J is a partial cross-sectional view of a load cell assembly in a disengaged state in Figure 15A

[0095] Figure 15K is a side elevational view of a cradle of a load cell assembly in Figure 15A

[0096] Figure 15L is a front elevational view of a cradle in Figure 15K

[0097] Figure 15M is a perspective view of a container in a cradle in Figure 15K

[0098] Figure 16A is a flowchart of a method according to at least one example embodiment of the present disclosure;

[0099] Figure 16B shows a blood component separation system connected to a network according to at least one example embodiment of the present disclosure;

[0100] Figure 16C shows a graphical user interface according to at least one example embodiment of the present disclosure;

[0101] ​​​​​​​​​ Figure 16D is a block diagram of a computing system in accordance with at least one example embodiment of the present disclosure;

[0102] Figure 17A is a flow diagram of a method in accordance with at least one example embodiment of the present disclosure;

[0103] Figure 17B shows a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0104] Figures 17C to 17E shows an output device in accordance with at least one example embodiment of the present disclosure;

[0105] Figure 18A is a partial exploded perspective view of a blood component separation system including a modular serviceable carriage in accordance with at least one example embodiment of the present disclosure;

[0106] Figure 18B is a schematic elevational cross-sectional view of a modular serviceable carriage of the blood component separation system in

[0107] Figure 18C is a schematic elevational cross-sectional view of a modular serviceable carriage of the blood component separation system in Figure 18A is a bottom perspective view of a recirculation pump assembly of the blood component separation system in

[0108] Figure 18D is a schematic elevational cross-sectional view of a modular serviceable carriage of the blood component separation system in Figure 18C

[0109] Figure 18E shows a flow diagram of a method of servicing a blood component separation system in accordance with at least one example embodiment of the present disclosure;

[0110] Figure 19A is a perspective view of a collection bottle in accordance with at least one example embodiment of the present disclosure;

[0111] Figure 19B is an elevational view of a collection bottle in Figure 19A

[0112] is a perspective view of a can of a collection bottle in Figure 19C Figure 19A is a top view of a cap of a collection bottle in

[0113] Figure 19D Figure 19A is a top view of a cap of a collection bottle in​​​

[0114] Figure 19E is a bottom view of a cap of a collection bottle in Figure 19A

[0115] Figure 19F is a partial cutaway view of a collection bottle in Figure 19A before collection (i.e., before use) according to at least one example embodiment of the present disclosure;

[0116] Figure 19G is a partial view of a collection bottle in Figure 19A after collection (i.e., after use) according to at least one example embodiment of the present disclosure;

[0117] Figure 19H is an elevation view of a collection bottle shipping package including multiple rows of filled collection bottles (i.e., after collection) according to at least one example embodiment of the present disclosure;

[0118] Figure 19I is a side view of a collection bottle in Figure 19A set in a collection cradle according to at least one example embodiment of the present disclosure;

[0119] Figure 19J is a perspective view of a collection bottle in Figure 19A set in a collection cradle according to at least one example embodiment of the present disclosure;

[0120] Figure 20 is a flowchart of a method according to at least one example embodiment of the present disclosure;

[0121] Figure 21A is a partial perspective view of a blood component separation system in Figure 18A according to at least one example embodiment of the present disclosure;

[0122] Figure 21B is an elevation view of a first hanger assembly of a blood component separation system in Figure 21A according to at least one example embodiment of the present disclosure;

[0123] Figure 21C is an exploded perspective view of a first hanger assembly in Figure 21B according to at least one example embodiment of the present disclosure;

[0124] Figure 21D is an elevation view of a second hanger assembly of a blood component separation system in Figure 21A according to at least one example embodiment of the present disclosure;

[0125] Figure 21E is an exploded perspective view of a second hanger assembly in Figure 21D ​exploded perspective view of a second hanger assembly in the

[0126] Figure 21F a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21A perspective view of an air assembly of a blood component separation system in the

[0127] Figure 21G a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21A partial perspective view of a centrifuge housing of a blood component separation system in the

[0128] Figure 21H a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21A perspective view of a centrifuge assembly in a cover-locked state of a blood component separation system in the

[0129] Figure 21I a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H partial exploded perspective view of a catch engagement plate and catch assembly of a centrifuge in the

[0130] Figure 21J a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H perspective view of a cover engagement plate of a centrifuge assembly in the

[0131] Figure 21K a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H perspective view of a cover of a centrifuge assembly in the

[0132] Figure 21L a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H perspective view of a base of a centrifuge assembly in the

[0133] Figure 21M a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H partial bottom perspective view of a centrifuge assembly in a locked state in the

[0134] Figure 21N a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21M partial bottom perspective view of a centrifuge assembly in an unlocked state in the

[0135] Figure 21O a centrifuge assembly in accordance with at least one example embodiment of the present disclosure Figure 21H perspective view of a compressor assembly in a cover-unlocked state in the

[0136] Figure 22A flowchart of a method in accordance with at least one example embodiment of the present disclosure

[0137] Figure 22B is a flow diagram of a method according to at least one example embodiment of the present disclosure;

[0138] Figure 22C shows a centrifuge chamber according to at least one example embodiment of the present disclosure;

[0139] Figure 23A is an elevation sectional view of a flexible pipe condition sensor according to at least one example embodiment of the present disclosure;

[0140] Figure 23B is Figure 23A is a perspective view of a flexible block of a flexible pipe condition sensor in

[0141] Figure 23C is a schematic illustration of exaggerated displacement of a flexible block when pressure is applied to a pipe segment engaged with the flexible block in Figure 23B

[0142] Figure 23D is a perspective view of another example of a flexible block of a flexible pipe condition sensor according to at least one example embodiment of the present disclosure;

[0143] Figure 24A is a front view of a blood component collection circuit in Figure 5A according to an example of the present disclosure;

[0144] Figure 24B is an elevation view of a blood component collection circuit in Figure 24A according to at least one example embodiment in a first collapsed state;

[0145] Figure 24C is an elevation view of a blood component collection circuit in Figure 24A according to at least one example embodiment in a second collapsed state;

[0146] Figure 24D is an elevation view of a blood component collection circuit in Figure 24A according to at least one example embodiment in a third collapsed state;

[0147] Figure 24E is a bottom plan view of a blood component collection circuit with folded and packaged capsules according to at least one example embodiment of the present disclosure;

[0148] Figure 24F is a perspective view of a blood component collection device in Figure 5A according to at least one example embodiment;

[0149] Figure 24G is a perspective view of a blood component collection device in​ Figure 24F perspective view of the blood component collection circuit in the absence of a sealing band wrapping;

[0150] Figure 24H is a perspective view of a centrifuge assembly in accordance with at least one example embodiment of the present disclosure; Figure 24A top plan view of the blood component collection circuit in the absence of a sealing band wrapping;

[0151] Figure 24I is a perspective view of a centrifuge assembly in accordance with at least one example embodiment of the present disclosure; Figure 4B detail schematic plan view of a portion of the collection insert channel of the centrifuge assembly in the absence of a sealing band wrapping;

[0152] Figure 24J is a perspective view of a centrifuge assembly in accordance with at least one example embodiment of the present disclosure; Figure 24I detail schematic plan view of a portion of the collection insert channel of the centrifuge assembly in the absence of a sealing band wrapping;

[0153] Figure 25A is a perspective view of another soft cassette in accordance with at least one example embodiment of the present disclosure;

[0154] Figure 25B is a side elevational view of a soft cassette in accordance with at least one example embodiment of the present disclosure; Figure 25A

[0155] Figure 25C Figure 25A

[0156] Figure 25D is a perspective view of a soft cassette assembly including a soft cassette in accordance with at least one example embodiment of the present disclosure; Figure 25A

[0157] Figure 25E Figure 25D

[0158] Figure 25F Figure 25A

[0159] Figure 25G Figure 25A

[0160] Figure 25H Figure 25A

[0161] Figure 25I ​​​​​​​​​​​​is a perspective view of a soft cassette in accordance with at least one example embodiment of the present disclosure Figure 25A is another exploded view of the soft cassette in

[0162] Figure 25J is a flow diagram illustrating a manufacturing method of a soft cassette in accordance with at least one example embodiment of the present disclosure Figure 25A is a detailed cross-sectional view of a valve region in accordance with at least one example embodiment of the present disclosure

[0163] Figure 25K is a perspective view of a soft cassette in accordance with at least one example embodiment of the present disclosure Figure 25A is a partial cross-sectional view of a valve region in accordance with at least one example embodiment of the present disclosure

[0164] Figure 25L is a detailed cross-sectional view of a valve region in accordance with at least one example embodiment of the present disclosure Figure 25K

[0165] Figure 25M is a perspective view of another soft cassette in accordance with at least one example embodiment of the present disclosure

[0166] Figure 26A is a perspective view of a separation device in a packed state in accordance with at least one example embodiment of the present disclosure

[0167] Figure 26B is an elevation view of a separation device in a packed configuration in accordance with at least one example embodiment of the present disclosure Figure 26A

[0168] is a schematic view of a separation assembly including a separation device in accordance with at least one example embodiment of the present disclosure Figure 26C Figure 26A

[0169] Figure 26D is a schematic view of a blood component separation system including a properly installed component collection assembly in accordance with at least one example embodiment of the present disclosure

[0170] Figure 26E is a partial perspective view of a valve housing of a blood component separation system in accordance with at least one example embodiment of the present disclosure Figure 26D

[0171] Figure 26F is a schematic view of a blood component separation system including an improperly installed component collection assembly in accordance with at least one example embodiment of the present disclosure

[0172] Figure 26G is a schematic view of an anticoagulant (AC) bag of a separation assembly in accordance with at least one example embodiment of the present disclosure Figure 26C

[0173] ​​​​​ Figure 26H is a perspective view of a container in a carrier in a blood component separation system in accordance with at least one example embodiment of the present disclosure; Figure 26C is a schematic view of a saline bag of a separation assembly in

[0174] Figure 26I is a perspective view of a container in a carrier in a blood component separation system in accordance with at least one example embodiment of the present disclosure; Figure 26D is a perspective view of a container in a carrier in a blood component separation system in accordance with at least one example embodiment of the present disclosure; and

[0175] Figure 26J is a perspective view of a container in a carrier in a blood component separation system in accordance with at least one example embodiment of the present disclosure; Figure 26I is a perspective view of a container in a carrier in a blood component separation system in accordance with at least one example embodiment of the present disclosure.

[0176] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0177] Example embodiments now will be described more fully hereinafter with reference to the accompanying drawings.

[0178] Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. Those skilled in the art will recognize, however, that the embodiments can be practiced without one or more of the specific details. In some embodiments, well-known fasteners, structures, and techniques are not described in detail.

[0179] The terminology used by the present disclosure is intended to be interpreted in only a descriptive sense, and is not intended to be limiting. As used by the present disclosure, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and the like are to be construed to be inclusive (i.e., to mean "including but not limited to"), unless explicitly indicated to be terminologically exclusive. The methods described by the present disclosure are to be understood as not necessarily being performed in the particular order described, unless explicitly stated or implicitly implied by, and optionally required by, the particular context. Additional or alternative steps can also be employed.

[0180] When an element or layer is referred to as being “on”, “engaged to”, “connected to” or “coupled to” another element or layer, it can be directly on, engaged, connected or coupled to the other element or layer, or one or more intervening elements or layers can be present. 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 are no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between”, “adjacent” versus “directly adjacent”, etc.). As used in the present disclosure, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0181] Although the terms first, second, third, etc. can be used herein 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 can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first”, “second”, and other numerical terms when used in the present disclosure do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0182] For ease of description, the present disclosure can use spatial relative terms, such as “inner”, “outer”, “lower”, “bottom”, “lower than”, “upper”, “higher than”, etc., to describe the relationship of one element or feature to other one or more elements or features as shown in the drawings. In addition to the orientation shown in the drawings, the spatial relative terms can also be intended to encompass different orientations of the device in use or operation. For example, if the device in the drawings is turned over, an element described as being “below” or “under” other elements or features would be “above” the other elements or features. Thus, the exemplary term “below” can encompass above and below. The device can be oriented in other ways (rotated 90 degrees, or in other orientations), and the spatial relative descriptive terms used in the present disclosure are interpreted accordingly.

[0183] Various components in the present disclosure are referred to as being "operatively associated." As used in the present disclosure, "operatively associated" refers to components that are linked in an operable manner, including embodiments in which the components are directly linked and embodiments in which additional components are placed between the linked components. "Operatively associated" components can be "fluidly associated." "Fluidly associated" refers to components that are linked such that a fluid can be transported between them. "Fluidly associated" includes embodiments in which additional components are placed between the two fluidly associated components and embodiments in which the components are directly connected. Fluidly associated components can include components that do not contact the fluid but contact other components to manipulate the system (e.g., a peristaltic pump, which pumps fluid through a flexible tube by compressing the outside of the tube).

[0184] The term "donor" as used in the present disclosure can refer to any person providing fluid (e.g., whole blood) to a blood component separation system. A donor can also be a patient who is temporarily providing fluid to a blood component separation system for processing, treatment, manipulation, etc., and then returning the fluid to the patient.

[0185] The term "automatically" and variations thereof as used in the present disclosure refers to any process or operation that is completed without human substantial input in performing the process or operation. However, a process or operation is still considered to be automatic if human input, substantial or insubstantial, is used in performing the process or operation, so long as the input is received prior to performing the process or operation. Human input is considered to be substantial if it affects the performance of the process or operation. Human input that is consented to for performing the process or operation is not considered to be "substantial."

[0186] The term "computer-readable medium" as used herein refers to any tangible storage and / or transmission medium that participate in providing instructions to a processor for execution. Such a medium can take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, NVRAM, floppy diskettes, magnetic floppy disks, hard disk drives, or any other magnetic storage medium, magnetic cassettes, tape, or any other magnetic medium, magneto-optical medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EPROM, a solid state medium like a memory card, any other memory chip or cartridge, a carrier wave transported over a wire, air, or any other wireless medium, or any other medium from which a computer can read. Digital file attachments to email or other self-contained information archives or sets of archives are considered to be equivalent to a tangible storage medium for purposes of this disclosure. When the computer-readable medium is configured as a database, it should be understood that the database can be of any type

[0187] The term "module" as used herein refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of performing the functionality associated with that element.

[0188] The terms "determine," "calculate," and "compute," and variations thereof, as used herein, are used interchangeably and include any type of method, process, mathematical operation, or technique.

[0189] Embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings, which can be illustrative embodiments in which blood component separation methods and systems are described. The following embodiments can be described in terms of separating blood components from whole blood. However, these example processes are for illustration only. It should be noted that the embodiments are not limited to the description below. These embodiments are intended to be used in products, processes, apparatuses, and systems to separate any complex liquid. Accordingly, the present disclosure is not limited to separating blood components from whole blood.

[0190] Referring to Figure 1 FIG. 1 shows a perspective view of an operating environment 100 of a blood component separation system 200, in accordance with at least one example embodiment of the present disclosure. The operating environment 100 can include the blood component separation system 200, a donor 102, and one or more connections (e.g., a donor supply tube 104, a cassette inlet tube 108A, an anticoagulant tube 110, etc.) that connect from the donor 102 to the blood component separation system 200, and vice versa. As shown in FIG. 1, the donor 102 can be connected to the blood component separation system 200 via the donor supply tube 104, the cassette inlet tube 108A, and the anticoagulant tube 110. The donor supply tube 104 can be connected to the donor 102 at a first end and to the blood component separation system 200 at a second end. The cassette inlet tube 108A can be connected to the donor 102 at a first end and to the blood component separation system 200 at a second end. The anticoagulant tube 110 can be connected to the donor 102 at a first end and to the blood component separation system 200 at a second end. Figure 1As shown, the donor supply line 104 can be fluidly connected to at least one blood vessel (e.g., a vein) of the donor 102 via a venipuncture. For example, a cannula connected to an end of the donor supply line 104 can be inserted through the skin of the donor 102 to a target site or vein. Such a connection can provide venous access for blood to flow from the donor 102 to the blood component separation system 200 and / or for blood components to flow back to the donor 102. In at least one example embodiment, the fluid pathways and connections can form extracorporeal tubing of the blood component separation system 200.

[0191] Blood supplied by the donor 102 can flow along the donor supply line 104, through the tubing connector 106, and along the cassette inlet line 108A into the soft cassette assembly 300. The soft cassette 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 an anticoagulant supply contained in an anticoagulant (AC) bag 114. The anticoagulant can be pumped at least through the anticoagulant line 110 and the tubing connector 106 to prevent coagulation of blood in the blood component separation system 200.

[0192] The anticoagulant can include, but is not limited to, one or more of citrate and / or ordinary heparin. The AC bag 114 and other bags or bottles described in the present disclosure can 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, thermoplastic, thermoplastic elastomer, polymer, copolymer, and / or combinations thereof. The volume of AC in the AC bag 114 can vary based on various factors, including the mass of the donor 102, the volumetric flow rate of blood from the donor, and the like. In one example, the volume of the AC bag 114 can be 250 to 500 milliliters, however the volume within the AC bag 114 can be greater or less than this volume.

[0193] In at least one example embodiment, the blood component separation system 200 can include a plasma collection bottle 122 or container, a saline fluid contained in a saline bag 118, and one or more lines or conduits, such as a saline line 116 and a plasma line 120 (e.g., fluid transfer tubes, etc.), that connect the saline bag 118 and the plasma collection bottle 122 with extracorporeal tubing 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 larger or smaller than this amount. An example donation of a blood component (e.g., plasma) can be 880 milliliters. Accordingly, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one example embodiment, the plasma collection bottle 122 can include a connection point (e.g., as shown in FIG. 2A) that is disposed at or proximate to a generally bottom-most portion of the plasma collection bottle 122 when the plasma collection bottle 122 is seated in the plasma collection cradle 232C. The connection point can include one or more connectors configured to interconnect with the plasma line 120 to receive and / or deliver plasma. The disposition of the plasma collection bottle 122 bottom connection point can be such that plasma contained in the plasma collection bottle 122 is removed from the plasma line 120 through the line without trapping air bubbles, etc., as described herein. In at least one example 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 a bottle-like container. Figure 2A

[0194] Figure 2A Figure 1 ​​A perspective view of a blood component separation system 200 is depicted in FIG. 1. The blood component separation system 200 can provide a continuous whole blood separation process. In at least one example embodiment, whole blood can be drawn from a donor 102 and provided substantially continuously to a blood component separation apparatus 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 example embodiment, one or more of the separated blood components can be collected for subsequent use or returned to the donor 102. The 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 example embodiment, the donor supply tubing 104, the cartridge inlet tubing 108A, the inlet tubing 108B (also referred to herein as the circuit inlet tubing 108B), the outlet tubing 112 (also referred to herein as the circuit outlet tubing 112), the saline tubing 116, and the plasma tubing 120 used in extracorporeal tubing can collectively define a closed, sterile, and disposable system or blood component collection set, which can be described further below.

[0195] Examples of blood component separation systems, plasma separation systems, and other separation systems that can be used with embodiments of the present disclosure, such as the blood component separation system 200, include, but are not limited to, SPECTRA® Blood component separation systems, Spectra® blood component separation systems and TRIMA® AutoPure® automated blood collection systems, all of which are manufactured by Terumo BCT of Lakewood, Colorado.

[0196] The operation of 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 a plurality of embedded computer processors as part of a computer system. The computer system can 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 touchscreens, one or more video 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, etc. In at least one example embodiment, to assist an operator of the blood component separation system 200 in various aspects of operation, the blood component separation device or centrifuge can include a graphical user interface having a display that includes an interactive touchscreen.

[0197] The blood component separation system 200 can include a housing 204 and / or structural frame, a cover 210, access panels 224 disposed at the front 202 and / or rear 206 of the blood component separation system 200, and one or more supports 232A-C including hooks, brackets, cradles, arms, protrusions, plates, and / or other support structures for securing, supporting, and / or otherwise supporting containers or AC bags 114, saline bags 118, or plasma collection bottles 122. In at least one example 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 in the coordinate system. 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 (such as the cover 210, doors, subassemblies, and / or assemblies) are attached. In at least one example embodiment, at least one panel of the blood component separation system 200 can include a mounting surface for the soft cassette assembly 300, one or more pumps (such as the suction pump 208, the return pump 212, or the anticoagulant (AC) pump 216), and / or a fluid valve control system 228 (e.g., plasma and saline valve controls, etc.).

[0198] The access panel 224 can include one or more handles, locks, and pivot or hinge axes 226 (e.g., door hinges, piano hinges, continuous hinges, clean room hinges, etc.). In any case, the access panel 224 can be selectively opened to provide access to the interior of the blood component separation system 200, and more particularly, to the blood separation assembly or centrifuge. In at least one example embodiment, the access panel 224 can provide access for loading and / or unloading the centrifuge with one or more assemblies in the blood component collection set. Details of the centrifuge will be described in greater detail below with reference to, at least, FIGS. 3-5. Figures 4A to 4L

[0199] 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 house the centrifuge, the rotary 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 example embodiment, access to the control portion (e.g., configured to house or otherwise contain the motor controller, CPU or one or more processors, electronics, wiring, etc.) can be provided by a solidly fixed panel of the housing 204 and / or a panel separate from the access panel 224.

[0200] In at least one example embodiment, the blood component separation system 200 can include a plurality of pumps, such as the suction pump 208, the return pump 212, or the AC pump 216, configured to control the flow of fluids (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 can include the suction pump 208 that controls the flow of blood to and / or from the donor 102 into the centrifuge of the blood component separation system 200. The suction pump 208 can interface with a portion of the inlet tube 108B disposed between the soft cassette assembly 300 and the centrifuge of the blood component separation system 200. In at least one example embodiment, the blood component separation system 200 can include the return pump 212 configured to control the flow of separated blood components (e.g., plasma, etc.) from the centrifuge to the plasma collection bottle 122 and / or the 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 can control the flow of saline (e.g., supplied from the saline bag 118) throughout the blood component collection set and / or the blood component separation system 200. The AC pump 216 can interface with a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant in the blood component collection set of the blood component separation system 200. As will be described in greater detail below, the AC pump 216 can be configured to control the flow of anticoagulant from the anticoagulant bag 118 to the donor 102 and / or the flow of anticoagulant from the donor 102 to the anticoagulant tube 110. Figure 2A ​As shown, the suction pump 208, the return pump 212, and the AC pump 216 can be at least partially disposed on top of the cover 210 of the blood component separation system 200.

[0201] Figure 2B and Figure 2C Various perspective views of the suction pump 208, the return pump 212, or the AC pump 216 of the blood component separation system 200 in accordance with at least one example embodiment of the present disclosure are shown. Although the following description is provided in connection with the suction pump 208, 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) can be different and operate differently in some details; however, in many cases, the return pump 212 and / or the AC pump 216 can be or can include substantially similar, if not identical, structures as the suction pump 208. Figure 2B and Figure 2C The suction 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) can be different and operate differently in some details; however, in many cases, the return pump 212 and / or the AC pump 216 can be or can include substantially similar, if not identical, structures as the suction pump 208.

[0202] The suction pump 208 can include a pump cover 236 or housing configured to at least partially enclose a moving element of the suction pump 208. In at least one example embodiment, the pump cover 236 can include a hinged conduit guard door subassembly or conduit guard 240 configured to open and close about a conduit guard pivot axis 242. In at least one example embodiment, the conduit guard 240 can be attached to the pump cover 236 by one or more fasteners disposed along the conduit guard pivot axis 242. As shown, the conduit guard 240 can be configured to at least partially enclose the moving element of the suction pump 208 when the conduit guard 240 is closed about the conduit guard pivot axis 242. Figure 2B and Figure 2C As shown, blood provided by the donor 102 can be transported or drawn by the suction pump 208 into the centrifuge in a first suction or centrifugal direction 250A. Additionally or alternatively, blood or other fluids can be transported or drawn by the suction pump 208 in a donor direction 250B opposite the centrifugal direction 250A toward the donor 102.

[0203] In at least one example 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 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 a rotating tubing contact assembly. In operation, the 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 the rotating tubing contact head. In at least one example 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, thereby providing a loading gap region, and vice versa. The rotating tubing contact head can include a plurality of rotating pressure rollers 268 configured to rotate about a respective pressure roller rotation axis 264. Each rotating pressure roller 268 can be disposed between a first rotating pump plate 272A and a second rotating pump plate 272B, where the first rotating pump plate 272A and the second rotating pump plate 272B are configured to rotate about a pump rotation axis 260. In at least one example embodiment, the rotating pressure rollers 268 can be disposed about the first rotating pump plate 272A and the second rotating pump plate 272B.

[0204] One or more of the suction pump 208, the return pump 212, or the AC pump 216 can include a Model UX-74130 peristaltic pump and a MEC-O-MATIC series pump, or operate similarly thereto, all of which listed pumps are manufactured by Pulsafeeder, Inc. of Punta Gorda, Florida, although the suction pump 208, the return pump 212, or the AC pump 216 are not limited thereto. Other examples of the suction pump 208, the return pump 212, or the AC pump 216 can include, but are not limited to, an INTEGRA DOSE IT laboratory peristaltic pump manufactured by INTEGRABiosciences AG of Switzerland, and a WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pump manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0205] Once the tubing is loaded into the lead tube guide 244, the tubing pressure block 248, and / or the end tube guide 252, at least some of the rotating pressure rollers 268 can be brought into engagement, contact, or otherwise compression with the tubing disposed between the rotating tube contact head and the tubing pressure block 248. As the first rotating pump plate 272A and the second rotating pump plate 272B rotate about the pump rotation axis 260, the rotating pressure rollers 268 can compress portions of the tubing between the suction pump 208, the return pump 212, or the AC pump 216 and the tubing pressure block 248, thereby causing fluid within that portion of the tubing to 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 rotating pump plate 272A and the second rotating pump plate 272B rotate in a counterclockwise direction about the pump rotation axis 260, the rotation of the rotating pressure rollers 268 compresses the tubing between the rotating pressure rollers 268 and the tubing pressure block 248, thereby causing fluid to move or be pumped in the centrifugal direction 250A. As another example, as the first rotating pump plate 272A and the second rotating pump plate 272B rotate in a clockwise direction about the pump rotation axis 260, the rotation of the rotating pressure rollers 268 compresses the tubing between the rotating pressure rollers 268 and the tubing pressure block 248, thereby causing fluid to move or be pumped in the donor direction 250B. When not actively pumping, the pump 208 can maintain a state where at least one rotating pressure roller 268 continues to block the inlet tube 108B (normally closed or NC), or a state where none of the rotating pressure rollers 268 block the inlet tube 108B (normally open or NO). Thus, based 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 can also have this capability.

[0206] 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 .

[0207] 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 .

[0208] 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.

[0209] The saline and plasma valve housing 276 can include a plurality of receiving features (e.g., recesses, channels, receptacles, etc.) that receive the outlet tube 112, the saline tube 116, the plasma tube 120, and / or a portion of the saline and plasma tube y-connector 280. Upon detection of 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 example embodiment, detection of air via the air detection sensor 284 can be used to indicate an operational step and / or trigger a step in a control method as described herein.

[0210] The plasma flow control valve 286 and / or the saline flow control valve 288 can be solenoid valves, linear actuators, pinch valves, clamp valves, gate valves, and / or other actuatable valves configured to selectively alter (e.g., occlude) a fluid pathway associated with a particular portion of the outlet tube 112, the saline tube 116, or the plasma tube 120. As shown, the plasma flow control valve 286 can be configured to pinch a portion of the plasma tube 120 contained at least partially in a receiving feature of the saline and plasma valve housing 276. The saline flow control valve 288 can be configured to pinch a portion of the saline tube 116 contained at least partially in a receiving feature of the saline and plasma valve housing 276. In any case, the plasma flow control valve 286 and the saline flow control valve 288 can include an actuatable extendable finger that moves from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of a tubing contained in the saline and plasma valve housing 276. While the plasma flow control valve 286 and the saline flow control valve 288 can fully pinch the tubing (e.g., fully restrict fluid flow through the tubing), it should be appreciated that the plasma flow control valve 286 and the saline flow control valve 288 can be actuated partially to a position that partially restricts fluid flow through a portion of the tubing. Figure 2D

[0211] It should be appreciated that the draw pump 208, the return pump 212, and the AC pump 216 include additional components that are described, for example, in U.S. Application No. 18 / 116,527 (Attorney Docket No. 18955-000029-US), entitled “Fluid Control and Bypass Features for Blood Component Separation Systems,” filed March 2, 2023, the entirety of which is incorporated by reference herein.

[0212] First example of a softbox with integrated features

[0213] Figure 3A is a partial perspective view of a soft cassette assembly in accordance with at least one example embodiment.

[0214] In at least one example embodiment, as Figure 3A ​As shown, a detailed perspective view of a disposable soft cassette assembly 300 according to embodiments of the present disclosure is shown. The soft cassette assembly 300 can include a base plate 302 and a cassette access door 304 attached to the base plate 302 by at least one hinge 306 and / or a cassette access door latch 308. In at least one example embodiment, the cassette access door 304 can be unlocked by actuating the cassette access door latch 308 and pivoting the cassette access door 304 about a cassette access door hinge axis 310.

[0215] In at least one example embodiment, the soft cassette assembly 300 can be configured with one or more soft cassette receiving features 312 for at least partially housing and / or positioning a soft cassette 314 within the soft cassette receiving features 312. The soft cassette 314 can be part of a blood component collection set as described herein. For example, the soft cassette 314 can be disposed between a cassette inlet tube 108A and a circuit inlet tube 108B of an extracorporeal circuit (as shown, for example, in FIG. 1A). Figure 5A In at least one example embodiment, the soft cassette 314 can provide one or more features for controlling the flow of blood and / or blood components from the donor 102 (as shown, for example, in FIG. 1A) to the blood component separation system 200 (as shown, for example, in FIG. 1A) and / or vice versa. Figure 1 A Figure 1 A

[0216] In at least one example embodiment, the soft cassette 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 cassette 314. In at least one example embodiment, these components can be independently embedded in a portion of the cassette access door 304, the base plate 302, and / or the housing 204 of the blood component separation system 200 (as shown, for example, in FIG. 1A). Figure 1 A Figures 2B to 2C Similar to the shielded closure feature 254 described in connection with the blood component separation system 200, the soft cassette assembly 300 can include one or more door closure features 328. The door closure features 328 can include, but are not limited to, magnetic snaps, protrusions, tabs, and slots, and / or other connectors. In at least one example embodiment, the door closure features 328 can include pressure contact surfaces configured to retain or at least partially position the soft cassette 314 within the soft cassette assembly 300.

[0217] In at least one example embodiment, the valves 320A, 320B, 320C can include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamp valves, pipe valves, and / or other actuatable valves configured to selectively vary, for example, the obstruction (e.g., cross-sectional area, etc.) of a fluid passage associated with a particular portion of the soft cassette 314.

[0218] In at least one example embodiment, the soft cassette assembly 300 can include a first fluid control valve 320A configured to pinch a portion of the soft cassette 314 adjacent to the cassette inlet tube 108A. A second fluid control valve 320B can be configured to pinch a portion of the soft cassette 314 adjacent to the circuit inlet tube 108B. A suction fluid control valve 320C can be configured to pinch a portion of the soft cassette 314 along a branch tube extending from a point proximate the cassette inlet tube 108A to a point proximate the circuit inlet tube 108B. In at least one example embodiment, each of the valves 320A, 320B, 320C can include an actuable extendable finger that moves from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the soft cassette 314 contained in the soft cassette assembly 300. While the valves 320A, 320B, 320C can fully pinch a flow path in the soft cassette 314 (e.g., fully restrict fluid flow through the soft cassette 314), it should be appreciated that the valves 320A, 320B, 320C can be partially actuated to a position that partially restricts fluid flow through a portion of the soft cassette 314.

[0219] In at least one example embodiment, the sensors 316, 318 can be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, etc. In some cases, the fluid sensor 318 can be configured to determine whether fluid is present in the soft cassette 314 based on a position of a magnet relative to a portion of the soft cassette 314. For example, when the portion of the soft cassette 314 is filled with fluid, the magnet can be disposed at a first position from a surface of the soft cassette 314. On the other hand, when the portion of the soft cassette 314 is filled with air, a force from the magnet can compress the portion of the soft cassette 314 to a second position closer to the surface of the soft cassette 314 than the first position. In at least one example embodiment, detection of air or fluid via the air detection sensor 316 and the fluid sensor 318, respectively, can be used to indicate operational steps and / or trigger steps in control methods as described herein.

[0220] Figure 3B is a perspective view of a soft cassette of a soft cassette assembly in Figure 3A is a perspective view of a soft cassette of a soft cassette assembly in Figure 3C is a perspective view of a soft cassette of a soft cassette assembly in Figure 3A is a perspective view of a soft cassette of a soft cassette assembly in Figure 3B is a cross-sectional view of a soft cassette of a soft cassette assembly in Figure 3D is a cross-sectional view of a soft cassette of a soft cassette assembly in Figure 3A is a cross-sectional view of a soft cassette of a soft cassette assembly in Figure 3A is a cross-sectional view of a soft cassette of a soft cassette assembly in

[0221] 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.

[0222] 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.).

[0223] 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.

[0224] In at least one exemplary embodiment, the softbox 314 includes a first bypass branch 358 (e.g., Figure 3B 、 Figure 3D The first bypass branch 358 has a bypass flow lumen 360 (as shown in Figure 3D ) that is fluidly connected to a portion of the straight flow lumen 350 adjacent to the first cartridge port 340A, or as part of the first cartridge port 340A. In some embodiments, the bypass flow lumen 360 can extend from a point in the straight flow lumen 350 adjacent to the first cartridge port 340A, along the first bypass branch 358, through a second chamber or fluid pressure ring 362 (as shown in Figure 3B 、 Figure 3D ) to a second bypass branch 364 (as shown in Figure 3B 、 Figure 3D ) and then re-join the straight 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 flow lumen 364 provides a flow path within the soft cartridge 314 that bypasses the drip chamber 354.

[0225] In at least one example embodiment, controlling the flow path within the soft cartridge 314 or directing fluid within the soft cartridge 314 can include actuating the fluid control valves 320A, 320B, 320C (as shown in Figure 3A ) of the soft cartridge assembly 300 to block and / or open various compliance regions 370A, 370B, 370C (as shown in Figure 3BThe first compliance region 370A provides a pinch valve region at a point along the straight flow lumen 350 near the first cassette end 372 of the soft cassette 314 between the first cassette port 340A and the drip chamber 354. When the first fluid control valve 320A is actuated, the valve 320A can pinch the straight flow lumen 350 closed at this first compliance region 370A, thereby restricting or completely preventing fluid flow at that point in the soft cassette 314. The second compliance region 370B provides a pinch valve region at a point along the straight flow lumen 350 near the second cassette end 374 (e.g., opposite the first cassette end 372) between the second cassette port 340B and the drip chamber 354. When the second fluid control valve 320B is actuated, the valve 320B can pinch the straight flow lumen 350 closed at this second compliance region 370B, thereby restricting or completely preventing fluid flow at that point in the soft cassette 314. It can be appreciated that the third compliance region 370C, disposed along the first bypass branch 358 adjacent the fluid pressure ring 362, can provide a pinch valve region at a point along the bypass flow lumen 360. When the suction fluid control valve 320C is actuated, the valve 320C can pinch the bypass flow lumen 360 closed at this third compliance region 370C, thereby restricting or completely preventing fluid flow through the bypass flow lumen 360.

[0226] In at least one example embodiment, as shown in the elevational cross-sectional view taken through a plane that passes through the straight flow lumen 350 and the drip chamber 354, Figure 3C The straight flow lumen 350 passes from the first cassette port 340A through an inner lumen volume 376 of the drip chamber 354 to the second cassette port 340B. The straight flow lumen 350 can be formed as a fluid passageway that extends within a first tube segment 378, the inner lumen volume 376, and a second tube segment 379 of the soft cassette 314.

[0227] In at least one example embodiment, the bypass path of the soft cassette 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 example embodiment, a pressure septum 380 (as shown in Figure 3D The fluid pressure ring 362 and the pressure septum 380 are shown in the elevational cross-sectional view taken through a plane that passes through the fluid pressure ring 362 and a portion of the first bypass branch 358 and the second bypass branch 364. Figure 3D The fluid pressure ring 362 and the pressure septum 380 are shown in the elevational cross-sectional view taken through a plane that passes through the fluid pressure ring 362 and a portion of the first bypass branch 358 and the second bypass branch 364.

[0228] In at least one example 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 side stream lumen 360 includes an amount of fluid, air, and / or a combination of fluid and air. As described above, fluid can provide a greater resistance to movement when filling a portion of the fluid pressure ring 362 as compared to air filling the fluid pressure ring 362. This difference in resistance can be measured by the fluid sensor 316 to determine the amount and / or type of fluid (e.g., air, blood, etc.) in the side stream lumen 360 and / or the fluid pressure ring 362.

[0229] Exemplary Centrifuge Components

[0230] Figure 4A is a perspective view of an example centrifuge assembly 400 for use in a blood component separation system 200 in accordance with at least one example 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 enclosed by the housing 204 and / or one or more elements of the centrifuge chamber. Access to the interior space and the centrifuge assembly 400 can be provided through an access panel 224 disposed at the front 202 of the blood component separation system 200. For example, in Figure 4A the access panel 224 is shown open and in an open position along a hinge axis 226. The hinge axis 226 can correspond to a door hinge, a continuous hinge, a clean room hinge, and / or other panel hinge.

[0231] The centrifuge assembly 400 can be operably mounted within the blood component separation system 200 such that the centrifuge assembly 400 is capable of rotation relative to the housing 204 and / or other elements of the blood component separation system 200. The centrifuge assembly 400 can be loaded with one or more portions of a blood component collection set (e.g., the blood component collection set 500 shown in Figure 2A by introducing tubing (e.g., the inlet tube 108B and the outlet tube 112, etc.) into the interior space of the blood component separation system 200 through the opening 220 shown, connecting a portion of the blood component collection circuit 520 to the fixed circuit connector 402, and inserting the blood component collection bladder 536 into the filler 460, the centrifuge assembly 400 can be loaded with one or more portions of a blood component collection set (e.g., the blood component collection set 500 shown in FIGS. 5A-5H The fixed circuit connector 402 holds the inlet tube 108B and the outlet tube 112 in a fixed position and can prevent the tubes 108B, 112 from kinking outside of the blood component separation system 200. In at least one example embodiment, the blood component collection circuit 520 can be interconnected with the fixed circuit connector 402 through one or more keyed features or positive positioning features.

[0232] For illustrative purposes, FIGS. 4B-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., FIGS. 5A-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).

[0233] 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 FIGS. 4B-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. FIG. 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.

[0234] The centrifuge assembly 400 can include at least one clockwise rotation stop 408A, a counter-clockwise rotation stop 408B, an upper housing clockwise rotation flag 410A, and / or an upper housing counter-clockwise rotation flag 410B. In at least one example embodiment, the rotation stops 408A, 408B can be rotationally fixed relative to the centrifuge rotation axis 430 of the lower housing 404A. The rotation flags 410A, 410B can be attached to or formed in the upper housing 404B and configured to contact the respective rotation stops 408A, 408B to prevent over-rotation of the upper housing 404B relative to the lower housing 404A when locking and / or unlocking the two halves of the centrifuge split housing 404 together. For example, when the upper housing 404B is rotated in a clockwise or unlock direction about the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A can touch 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 counter-clockwise or lock direction about the centrifuge rotation axis 430, a portion of the upper housing counter-clockwise rotation flag 410B can touch the counter-clockwise rotation stop 408B, thereby preventing further rotation in the counter-clockwise direction. In at least one example embodiment, the centrifuge split housing 404 can include one or more locking elements configured to hold the halves of the centrifuge split housing 404 in a locked state when the locking elements are engaged.

[0235] In at least one example embodiment, the centrifuge split housing 404 can include a pull tab 412 attached to the partial upper housing 404B to pivot the upper housing 404B relative to the lower housing 404A about the split housing pivot axis 406. The pull tab 412 can provide an aperture through which a user can insert a finger and apply a pulling force to the rotationally unlocked upper housing 404B.

[0236] The centrifuge assembly 400 can include a rotor and motor assembly 414 that is controlled and / or powered by an electrical cable 420 of an electrical interconnect. The electrical cable 420 can include a connector that is attached to a controller, processor, and / or power source. The electrical cable 420 can carry 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 can be configured as an electric motor and / or as part of an electric 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 can include one or more components that cause the centrifuge assembly 400 (e.g., the two halves of the centrifuge split housing 404 together) to rotate inside the blood component separation system 200.

[0237] As described herein, the centrifuge assembly 400 can include one or more features to guide, contain, and / or position elements of the blood component collection set relative to the centrifuge split housing 404. For example, in FIG. 4B In the example shown in FIG. 4, the blood component collection set 520 is shown captured in an operational position of the set rotational position guide 424 that includes a set capture arm 416. The set rotational position guide 424 can include a plurality of bearings 417 and / or bearing surfaces arranged to at least partially support the blood component collection set 520 in the operational position. In the operational position, the blood component collection set 520 can be twisted along its length within the support provided by the bearings 417 of the set rotational position guide 424. For example, one end of the blood component collection set 520 can be fixedly attached to the stationary set connector 402 of the blood component separation system 200, while the other end of the blood component collection set 520 can be attached to the fill 460 (e.g., an internal rotating component of the centrifuge assembly 400). As the centrifuge assembly 400 rotates during a centrifugation operation, the twisting of the blood component collection set 520 between the connections at the stationary set connector 402 and the fill 460 can cause the fill 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In at least one example embodiment, the low inertia of the fill 460 coupled with the twisting of the blood component collection set 520 as the centrifuge assembly 400 rotates in the blood component separation system 200 can cause the fill 460 to rotate in the same rotational direction at twice the angular velocity of the centrifuge split housing 404. In this example, as the centrifuge split housing 404 rotates about the centrifuge rotational axis 430 in a counterclockwise direction at a first angular velocity 1 ω, the fill 460 can rotate within the centrifuge split housing 404 in a counterclockwise direction at a second angular velocity 2 ω (e.g., substantially twice the first angular velocity, etc.).

[0238] The centrifuge assembly 400 can include one or more balancing features, elements, and / or structures disposed about the centrifuge assembly 400's centrifuge rotation axis 430. These balancing features can provide an axially balanced centrifuge assembly 400 such that, when rotated on the centrifuge rotation axis 430, the centrifuge assembly 400 can generate substantially no vibrations to the blood constituent separation system 200. In at least one exemplary embodiment, a centrifuge balancing weight 418 can be attached to a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). This centrifuge balancing weight 418 can be custom tuned to the centrifuge assembly 400 and, as such, can be selectively attached to and removed from the centrifuge assembly 400. The tuning of this centrifuge balancing weight 418 can be derived through calculation and / or empirically to result in a perfectly balanced centrifuge assembly 400, particularly when the centrifuge assembly 400 is loaded with one or more elements of the blood constituent collection set.

[0239] FIG. 4CA rear perspective view of a centrifuge assembly 400 is shown in accordance with at least one example embodiment of the present disclosure. A portion of the fill 460 is visible through the 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 fill 460 and a second end is fixedly attached to the stationary circuit connector 402 (not shown). The blood component collection circuit 520 is shown passing through the circuit entry gap 436 in the centrifuge split housing 404. When the blood component collection circuit 520 is loaded in the circuit loading position 520A, a portion of the blood component collection circuit 520 can be partially housed, fixed, and / or supported by the circuit containment cradle 426. The circuit containment cradle 426 can include one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc. and / or combinations thereof, etc.) or bearing surfaces arranged to at least partially support the blood component collection circuit 520 when twisted relative to the centrifuge assembly 400. In at least one example 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 for relative rotational movement of the flexible circuit 524 relative to the circuit rotational position guide 424. For example, rather than “kinking,” the circuit actually rotates or rolls between the one or more bearings 417 relative to the circuit rotational position guide 424 (e.g., support structure). This rotation or twisting, without constraining or kinking the flexible circuit 524, can be referred to herein as twisting. The twisting allows the flexible circuit 524 to transfer rotational forces to the fill 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.

[0240] As described above, when the upper housing 404B is rotated from the FIGS. 4B-4C The locking tab 428 of the upper housing 404B can engage with the locking slot 432 of the lower housing 404A when the upper housing 404B is rotated from the rotational unlock position shown to the rotational lock position. Additionally or alternatively, when moved to the rotational lock position, the circuit containment cradle 426 can rotate with the upper housing 404B and the blood component collection circuit 520 along the circuit engagement position 520B to a position in line with the circuit rotational position guide 424. In at least one example embodiment, the circuit capture arm 416 can guide the blood component collection circuit 520 into the bearings 417 and / or bearing surfaces of the circuit rotational position guide 424 when the upper housing 404B and the blood component collection circuit 520 are rotated to the circuit engagement position 520B. The loading process of the blood component collection circuit 520 will be described in more detail below. FIGS. 6A-7B ​

[0241] FIGS. 4D-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.

[0242] 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.

[0243] FIG. 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, FIG. 4EAs shown, where the centrifuge assembly 400 is shown in a partially open state, the upper housing 404B and the fill 460 are rotated away from the lower housing rotation axis 430A. In this position, the fill 460 can be allowed to rotate about the fill rotation axis 430B. When the lower housing 404A and the upper housing 404B are in a closed state, the lower housing rotation axis 430A and the fill rotation axis 430B are aligned (coincident or substantially coincident) to form the centrifuge rotation axis 430.

[0244] Continuing to rotate the upper housing 404B and the fill 460 about the y-axis of the split housing pivot axis 406 in the opening direction 446 (e.g., by continuing to pull the pull ring 412) can cause the upper housing 404B and the fill 460 to rotate away from the closed position shown in FIG. 6A. As shown in FIG. 6B, the upper housing 404B and the fill 460 are rotated approximately 90 degrees from the closed position shown in FIG. 6A. FIG. 4D FIG. 4F As shown, the centrifuge assembly 400 is in an open or loading state. In this position, the upper housing 404B and the fill 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 fill 460 can be placed in the open space of the access panel 224. In this position, the loading access area 450 can be provided to the circuit connection area 454 of the fill 460. It can 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 passageway of the fill 460. In addition to this, such an arrangement can provide the operator with sufficient clearance to attach the blood component collection circuit 520 to the fill 460 at the circuit connection area 454.

[0245] Referring to FIG. 7, a perspective view of the fill 460 of the centrifuge assembly 400 is shown, in accordance with at least one example embodiment of the present disclosure. In at least one example embodiment, the fill 460 can be made of a lightweight material such as plastic, carbon fiber, aluminum, etc. In at least one example embodiment, the fill 460 can be 3D printed by a three-dimensional (3D) printer. For example, the fill 460 can be produced by an additive manufacturing technique or system such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or other additive manufacturing machines. In addition to this, these additive rapid prototyping techniques can allow the fill 460 to have more complex geometries that can not be achievable using traditional machining or manufacturing processes. In at least one example embodiment, the material of the fill 460 can be selected based on the desired mass of the fill 460, the desired physical strength of the manufactured fill 460, and / or suitable materials for manufacturing. FIG. 4G , a perspective view of the fill 460 of the centrifuge assembly 400 is shown, in accordance with at least one example embodiment of the present disclosure. In at least one example embodiment, the fill 460 can be made of a lightweight material such as plastic, carbon fiber, aluminum, etc. In at least one example embodiment, the fill 460 can be 3D printed by a three-dimensional (3D) printer. For example, the fill 460 can be produced by an additive manufacturing technique or system such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or other additive manufacturing machines. In addition to this, these additive rapid prototyping techniques can allow the fill 460 to have more complex geometries that can not be achievable using traditional machining or manufacturing processes. In at least one example embodiment, the material of the fill 460 can be selected based on the desired mass of the fill 460, the desired physical strength of the manufactured fill 460, and / or suitable materials for manufacturing.​

[0246] The filler 460 can include a circuit connection region 454 disposed generally at the center of the filler 460. The circuit connection region 454 can include one or more keyed or positive positioning features for engaging a portion of the blood component collection circuit 520. As shown, the circuit connection region 454 includes a first positive positioning feature 478 disposed along a portion of the central axis of the filler 460. The first positive positioning feature 478 can be a keyway, groove, slot, or other feature that engages a mating feature disposed on the blood component collection circuit 520. In at least one example embodiment, the filler 460 can include a second positive positioning feature 480 in the circuit connection region 454. The positioning features 478, 480 can prevent the blood component collection circuit 520 from rotating at the circuit connection region 454 and / or from disengaging from the circuit connection region 454 of the filler 460. FIG. 4G

[0247] In at least one example embodiment, the filler 460 can include a collection insertion channel 466 configured to receive and at least partially house a blood component collection bladder of a blood component collection device, and more particularly, the collection insertion channel 466 is configured to receive and at least partially house the blood component collection circuit 520. The collection insertion channel 466 can be configured as a groove, slot that extends outward in a generally helical manner from the center of the filler 460. In at least one example embodiment, the collection insertion channel 466 can follow a generally helical path that can include a first helical path portion that extends outward from the center of the filler 460 along a length of the periphery of the collection insertion channel 466 to a substantially constant radius (e.g., around the center of the filler 460). In any event, the path can be referred to herein as a helical path or a generally helical path. The collection insertion 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 a point furthest from the center of the filler body 464. As shown, the collection insertion channel 466 can include a second helical path portion that extends outward from the channel end 472 to a second helical path portion end 474. The second helical path portion can extend to a substantially constant radius (e.g., around the center of the filler 460) that is greater than the radius of the first helical path portion. In at least one example embodiment, the collection insertion channel 466 can include a third helical path portion that extends outward from the second helical path portion end 474 to a third helical path portion end 476. The third helical path portion can extend to a substantially constant radius (e.g., around the center of the filler 460) that is greater than the radius of the second helical path portion. In any event, the path can be referred to herein as a helical path or a generally helical path. FIGS. 4G-4I ​As shown, the collection insertion channel 466 can extend along a generally helical path 490 that extends from a point proximate the fill rotation axis 430B to the channel end 472. The generally helical path 490 can include a channel path inflection point 476 at a point proximate or adjacent the channel end 472. This channel path inflection point 476 can cause the collection insertion channel 466 to extend a distance from the center of the fill body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the collection insertion channel 466. In at least one example embodiment, this channel path inflection point 476 can correspond to a key inlet and outlet at a radial maximum within the blood component collection bladder 536 that is at least partially inserted or disposed within the collection insertion channel 466 of the fill 460. In at least one example embodiment, the fill 460 can include one or more fill balancing protrusions 482 disposed on, in, or around a portion of the fill body 464. These fill balancing protrusions 482 can provide an axially balanced (e.g., about the fill rotation axis 430B) fill 460, particularly when the collection insertion channel 466 includes a blood component collection bladder and fluid (e.g., blood, blood components, etc.).

[0248] FIG. 4I is a schematic plan view of a generally helical shaped receiving channel or collection insertion channel 466 of a fill 460 according to at least one example embodiment of the present disclosure. This schematic plan view shows a first distance Rl of the collection insertion channel 466 from the center of the fill body 464 (e.g., proximate the fill rotation axis 430B, etc.) at a first point along the generally helical path 490, and a second distance R2 of the collection insertion channel 466 from the center of the fill body 464 after passing a point proximate the channel path inflection point 476. As shown, the second distance R2 is further from the center of the fill body 464 than the first distance Rl. This increase in distance can be at a point proximate 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 helical path 490. In at least one example embodiment, an end of a blood collection bladder can substantially coincide with the channel end 472, thereby providing the greatest blood separation forces at the end of the bladder. FIG. 4I

[0249] FIGS. 4J-4L ​Various 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 FIG. 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.

[0250] FIG. 4LDifferent states of a fluid collection pouch (e.g., a blood component collection pouch, etc.) disposed inside the collection insertion channel 466 and the filler insertion chamber 492 of the filler 460 are shown. As described above, the blood component collection pouch can be inserted into the collection insertion channel 466 in a substantially flat or unfilled state SI. In the substantially flat state SI, the blood component collection pouch 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. As the filler 460 begins to rotate and separate blood components from the blood provided by the donor 102, the blood component collection pouch can expand from the substantially flat first state SI to an expanded or filled state S2. In at least one example embodiment, the blood component collection pouch can expand with blood and / or blood components until the walls of the blood component collection pouch contact the walls 494 and 496 of the filler insertion chamber 492. In at least one example embodiment, the shape of the filler insertion chamber 492 can be designed to optimize the amount of fluid that can be collected and / or separated in the filler insertion chamber 492 (e.g., maximize the volume of fluid while minimizing the amount of material of the filler 460).

[0251] Exemplary blood component collection device

[0252] FIGS. 5A-5H A blood component collection set 500 prepared according to at least one example embodiment of the present disclosure is shown. The blood component collection set 500 includes various connections, including, for example, tubes and connectors. For example, as shown, the blood component collection set 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, as well as one or more connectors, such as the tube connector 106 and / or the saline and plasma tube y-connector 280. The blood component collection set 500 can also include one or more other connectors, such as the first tube fitting 504, the second tube fitting 508, the bag fitting 512, the system static circuit connector 528, and / or the filler circuit connector 532. The various connections can fluidly connect the soft cartridge 340 and the blood component collection circuit 520.

[0253] The one or more tubing includes 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 (collectively referred to as “tubing”), each tube having a central lumen configured to transport fluid therethrough. The tubing can include one or more polymeric materials, including, for example, PVC, plasticized PVC, polyethylene, EVA, rubber, copolymers, and combinations thereof.

[0254] The one or more connectors include a tube connector 106, a saline and plasma tube 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 fill circuit connector 532 (collectively, "connectors"), each of which can be configured to fluidly interconnect tubing, and / or fluidly interconnect tubing and other medical accessories, and / or fluidly interconnect tubing and needles or spikes. For example, the connectors can be inserted into a central lumen of a corresponding tubing, and / or attached to an exterior of a corresponding tube, and / or the bag fitting 512 can be configured to be inserted into a receiving bag, such as the saline bag 118. In at least one example embodiment, the connectors can include various fittings, including, for example, luer fittings, twist-on connection fittings, and / or other small-bore couplings, to provide universal and / or reliable interconnections that establish fluid connections.

[0255] As shown, the blood component collection circuit 520 can include a flexible circuit 524 disposed between the system static circuit connector 528 and the fill 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-cured adhesive, as discussed further below. The flexible circuit 524 can be configured as a hollow flexible tube configured to receive and / or contain at least a portion of the circuit inlet tube 108B and the circuit outlet tube 112. In at least one example embodiment, the flexible circuit 524 can include a thermoplastic elastomer that enhances flexibility for transmitting a twist 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 retaining the strength and torque properties of plastic. Examples of thermoplastic elastomers can include, for example, copolyesters, DUPONT HYTREL® thermoplastic elastomers, EASTMAN NEOSTAR® thermoplastic elastomers, CELANESE SANTOPRENE® elastomers, TOYOBO CELEST® elastomers, and / or other similar brand elastomers with high flexibility and strength properties. TM thermoplastic elastomers, EASTMAN NEOSTAR® thermoplastic elastomers, CELANESE SANTOPRENE® elastomers, TOYOBO CELEST® elastomers, and / or other similar brand elastomers with high flexibility and strength properties. TM thermoplastic elastomers, EASTMAN NEOSTAR® thermoplastic elastomers, CELANESE SANTOPRENE® elastomers, TOYOBO CELEST® elastomers, and / or other similar brand elastomers with high flexibility and strength properties. thermoplastic elastomers, EASTMAN NEOSTAR® thermoplastic elastomers, CELANESE SANTOPRENE® elastomers, TOYOBO CELEST® elastomers, and / or other similar brand elastomers with high flexibility and strength properties. thermoplastic elastomers, EASTMAN NEOSTAR® thermoplastic elastomers, CELANESE SANTOPRENE® elastomers, TOYOBO CELEST® elastomers, and / or other similar brand elastomers with high flexibility and strength properties.

[0256] 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.

[0257] In at least one exemplary embodiment, FIG. 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 .

[0258] As shown, the first collection flow chamber 544 can be separated from the second collection flow chamber 552 by a flow chamber partition 542. In at least one example embodiment, the flow chamber partition 542 can be a sealed portion (e.g., heat sealed) of the blood component collection bladder 536. For example, in at least one example embodiment, the blood component collection bladder 536 can include and can be made from one or more overlapping and sealed layers of material. The layers of material can include one or more polymeric materials. For example, in at least one example embodiment, the layers of material can include PVC, plasticized PVC, polyethylene, EVA, thermoplastics, thermoplastic elastomers, copolymers, and combinations thereof.

[0259] The layers of material can be shaped (e.g., cut or otherwise shaped, etc.) and sealed along one or more edges to form the blood component collection bladder 536. As FIG. 5C and FIG. 5D shown, the flow chamber partition 542 can be formed in the blood component collection bladder 536 by sealing one or more layers of material to one or more other layers of material along one or more preselected paths, and / or sealing one or more first portions of a single layer of material to one or more second portions of the single layer of material. For example, as FIG. 5D shown, the blood component collection bladder 536 is shown prior to sealing, the flow chamber partition 542 can be formed as a sealed region of material by joining a bladder first side material 536A to a 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 a top and a bottom of the blood component collection bladder 536. In comparison, FIG. 5C the blood component collection bladder 536 is shown after sealing. As FIG. 5A and FIG. 5B shown, the seal defining the flow chamber partition 542 does not extend the entire length of the blood component collection bladder 536, thereby defining a flow chamber transition 548 such that fluid can pass between the first collection flow chamber 544 and the second collection flow chamber 552.

[0260] Once formed, the width of the bladder (WB) can correspond to the width of the first collection flow chamber 544 and / or the second collection flow chamber 552 in the unexpanded state (SI) (see FIG. 4L ). During operation, as fluid fills at least a portion of the blood component collection bladder 536, the width of the bladder (WB) can increase from FIG. 5CThe illustrated resting size increases. For example, in at least one example embodiment, the width (WB) of the pouch can increase substantially to the size of the filler insertion chamber 492 of the filler 460. In at least one example embodiment, the sealed weld portion of the blood component collection pouch 536 can be supported in the filler 460. For example, as shown FIG. 5G and FIG. 5H 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, as shown.

[0261] In at least one example embodiment, the blood component collection circuit 520 can include one or more positioning features (also referred to as key features) 530A, 530B configured to help positively position portions of the blood component collection circuit 520 relative to the blood component separation system 200, and more particularly, 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 positioning feature 530A located on or proximate to the system static circuit connector 528 and / or a second connector positioning feature 530B located on or proximate to the filler circuit connector 532. The positioning features 530A, 530B can be configured as keys, tabs, and / or other material protrusions that extend from the respective connectors 528, 532. In at least one example embodiment, the second connector positioning feature 530B can include features that interconnect (e.g., mate) with the first positive positioning feature 478 and / or the second positive positioning feature 480 of the circuit connection region 454 in the filler 460.

[0262] FIGS. 5E-5H are various perspective views of the blood component collection circuit 520 in a curved state, and also illustrate the curved blood component collection pouch 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 example embodiment, the flexibility can be elastic such that the shaping of the various portions of the blood component collection circuit 520 does not permanently deform the components.

[0263] FIG. 5E illustrates the blood component collection circuit 520 in a curved state. For example, in FIG. 5EIn some embodiments, the flexible circuit 524 is shown elastically bent along its length, and the blood component collection bladder 536 is shown having a plurality of bends or curves along its length. Nonetheless, the flexible circuit 524 provides fluid to the blood component collection bladder 536, e.g., via the circuit inlet tube 108B, and / or withdraws fluid from the blood component collection bladder 536, e.g., 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.

[0264] In at least one example embodiment, the blood component collection circuit 520 can be pre-shaped for installation within the collection insert channel 466 of the fill 460 of the centrifuge assembly 400, e.g., as shown in FIG. 5F Once pre-shaped, features of the blood component collection circuit 520 can be aligned with one or more features of the fill 460, e.g., as shown in FIG. 5G For example, in at least one example embodiment, the fill circuit connector 532 of the blood component collection circuit 520 can be aligned with the circuit connection region 454 of the fill 460 such that the second connector positioning feature 530B is aligned to engage with the first positive positioning 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 helical path 490 of the collection insert channel 466 in the fill 460. In at least one example embodiment, this 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 fill 460. When the components are generally aligned with one another, the blood component collection circuit 520 can be moved in a direction toward the collection insert channel 466 and the circuit connection region 454, e.g., as shown in FIG. 5G In at least one example embodiment, the first positive positioning feature 478 can interconnect and / or retain the second connector positioning feature 530B of the fill circuit connector 532 of the blood component collection circuit 520 as the fill circuit connector 532 is moved toward and into the circuit connection region 454 of the fill 460. This interconnection can prevent the fill circuit connector 532 from rotating relative to the fill 460. In at least one example embodiment, this interconnection can retain the fill circuit connector 532 of the blood component collection circuit 520 within the circuit connection region 454 of the fill 460. FIG. 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 work together to transfer torque applied to the flexible circuit 524 to the blood component collection bladder 536 and the filler 460.

[0265] In at least one example embodiment, fluid (e.g., blood and / or blood components, etc.) contained in the blood component collection bladder 536 in the filler insertion chamber 492 of the filler 460 can flow along the first collection flow chamber 544 around one end of the flow chamber partition 542 in a direction 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 components (e.g., plasma, etc.) can be forced back along the second collection flow chamber 552 along a generally spiral path 490 toward the center of the filler body 464 and through the circuit outlet tube 112 (e.g., to the plasma collection bottle 122).

[0266] Exemplary centrifuge assembly in a circuit loading state

[0267] FIGS. 6A-6C are schematic cross-sectional views of a centrifuge assembly 400 in various circuit loading states in accordance with at least one example embodiment of the present disclosure. As FIGS. 6A-6C indicated, the centrifuge assembly 400 can correspond to the centrifuge assembly 400 described above, particularly in connection with the FIGS. 4D-4F centrifuge assembly 400 described above. In particular, FIG. 6A a first circuit loading state of the centrifuge assembly 400 is shown, FIG. 6B a second circuit loading state of the centrifuge assembly 400 is shown, FIG. 6C a second circuit loading state of the centrifuge assembly 400 is shown.

[0268] In FIG. 6A , the centrifuge assembly 400 is shown in an open circuit loading position in which the upper housing 404B has been pivoted 180 degrees from the closed or operational position. This open position can correspond to the position of the centrifuge assembly 400 shown in FIG. 4F . However, in FIG. 6A , 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 region 454 of the filler body 464. The other end of the blood component collection circuit 520 is connected to the stationary circuit connection 402 via the system static circuit connector 528. In this first circuit loading state, the flexible circuit 524 is fixed against rotation at the stationary circuit connection 402, but is free to rotate in synchronization with the filler 460 at the circuit connection region 454.

[0269] In FIG. 6B In the partially closed position, the centrifuge assembly 400 is shown with the upper housing 404B being moved from an open position to a closed or operational position. As the upper housing 404B pivots, the flexible circuit 524 can move to a resting position relative to the centrifuge assembly 400. While the flexible circuit 524 can be rotatably fixed at the fixed circuit connector 402, the fill 460 can be free to rotate (e.g., limited only by the rotationally fixed flexible circuit 524) about the fill rotation axis 430B.

[0270] In FIG. 6C In the closed or operational position, the centrifuge assembly 400 is shown with the upper housing 404B can be locked to the lower housing 404A (such that the lower housing 404A and the upper housing 404B can be synchronously rotated about the centrifuge rotation axis 430). In this position, the flexible circuit 524 can pass from the circuit connection area 454 of the fill 460 through the circuit access gap 436 of the centrifuge split housing 404 to the fixed circuit connector 402. In at least one example embodiment, the flexible circuit 524 can be free to move within the circuit access gap 436 regardless of contact with one or more portions of the centrifuge split housing 404. In this position, as the centrifuge assembly 400 can be rotated about the centrifuge rotation axis 430, the rotationally fixed flexible circuit 524 at the fixed circuit connector 402 can twist along the length of the flexible circuit 524, thereby causing the fill 460 to rotate within the centrifuge assembly 400 (e.g., along the centrifuge rotation axis 430). As noted above, the rotation of the fill 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 circuit 524 (e.g., fixed at the fixed circuit connector 402) twists at the circuit connection area 454 (e.g., attempts to untwist from the rotational twist of the centrifuge assembly 400, etc.), thereby causing the fill 460 to rotate in the same rotational direction as the centrifuge assembly 400, but approximately two revolutions. This rotation of the fill 460 does not require a gear transmission between the centrifuge assembly 400 and the fill 460 through the twisting of the flexible circuit 524 along its length.

[0271] Exemplary centrifuge assembly in a circuit loading state

[0272] FIGS. 7A-7B A schematic plan view of the centrifuge assembly 400 is shown automatically loading the circuit into an operational position (e.g., blood separation) for centrifugation. FIGS. 7A-7B The centrifuge assembly 400 shown in FIGS. 4A-4F and / or FIGS. 6A-6COnce the blood component collection circuit 520 has been loaded into the centrifuge assembly 400, as described FIG. 6C As shown, the flexible loop 524 can be automatically loaded into the loop engagement position 520B, as shown in FIG. FIG. 7A and FIG. 7B shown.

[0273] 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 ... FIG. 4B and FIG. 4C The circuit receiving area or channel can be formed by the circuit position stop plate 704 and / or one or more circuit torsion support bearings 708 disposed along the length of the upper housing 404B. In at least one exemplary embodiment, the positioning can be designed to FIGS. 6A-6C The described circuit is accessible and / or easy to load during loading.

[0274] 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 FIG. 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.

[0275] When the flexible circuit 524 is held or at least partially contained within the circuit rotation position guide 424, a portion of the flexible circuit 524 can move within one or more of the circuit twist support bearings 708. As described above, the flexible circuit 524 can be rotationally fixed to the stationary circuit connector 402 by the first connector positioning feature 530A of the system static circuit connector 528 associated with the blood component collection circuit 520. This rotational fixation connection prevents the flexible circuit 524 from rotating relative to the blood component separation system 200 at the stationary circuit connector 402. The other end of the flexible circuit 524 can be interconnected at the circuit connection region 454 of the fill 460, where this end can move with the fill 460 and / or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the circuit and fill rotation direction 712, the force from the flexible circuit 524 attempting to untwist or prevent binding rotates the fill 460 and the end of the flexible circuit 524 connected thereto.

[0276] In any case, once the fluid separation process described herein is complete, the centrifuge assembly 400 can be stopped from rotating, and the centrifuge split housing 404 can be opened to remove the disposable components of the blood component collection set 500 from the centrifuge assembly 400. In some cases, by rotating the centrifuge assembly 400 and / or the fill 460 in a direction opposite the circuit and fill rotation direction 712, the flexible circuit 524 can be untwisted or prevented from binding from the fill 460 and / or the centrifuge assembly 400. FIG. 7B to the uncaptured circuit state 700A shown. FIG. 7A

[0277] Exemplary functional diagram of an exemplary blood component separation system

[0278] According to at least one example embodiment of the present disclosure, a functional diagram of the blood component separation system 200 can be as shown in FIG. 8 The description herein shows the components previously described in FIGS. 1-7B above in the form of a functional diagram to describe the operation of the system 200 in extracting plasma or other blood components from whole blood of a donor 102 in a blood component separation step or process.

[0279] ​The system 200 can include an anticoagulant (AC) pump 216. The AC pump 216 pumps fluid in the AC tube 110 from the AC bag 114. The AC pump 216, the AC tube 110, and / or the AC bag 114 can be as previously described. The AC tube 110 can also include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tube 110. The AC ADS 804 can be the same as or similar in type and / or function to the sensor 284 and / or the sensor 312 as previously described. The AC tube 110 can intersect and fluidly associate with the donor supply tube 104 and the cassette inlet tube 108A at the tube connector 106. The tube connector 106 can be any type of connection between the tubing 110, the tubing 104, and / or the tubing 108A as previously described.

[0280] The donor supply tube 104 taps from the donor 102, which can be stuck with a lumen needle or other device, allowing whole blood to flow from the donor 102 into the blood component separation system 200 and allowing blood components to flow back to the donor 102. The tubing 108A can tap into the soft cassette 340. Additionally, the donor air detection sensor 312 can be disposed on or in the tubing 108A to detect the presence of fluid and / or air within the tubing 108A.

[0281] As previously described, the soft cassette 340 can include a first cassette port 360A that can function as, include, and / or be approximately proximate to a first "Y" type connector or section, or branch, that divides the tubing 108A into a first bypass branch 358A and a first tube section 368A (the "Y" type section will be denoted by reference 360A). The two tube sections 358 and 368 can rejoin at a second cassette port 360B that can also function as, include, and / or be approximately proximate to a second "Y" type connector or section (the second "Y" type section will be denoted by reference 360B). The tubing 358 is bisected by the flow sensor 316, specifically, the flow sensor 316 divides the tubing 358 into the first bypass branch 358A and the second bypass branch 358B. Likewise, the tubing 368 is bisected by the drip chamber 354, specifically, the drip chamber 354 divides the tubing 368 into the first tube section 368A and the second tube section 368B.

[0282] The first tube segment 368A can include a first fluid control valve 320A. The second tube segment 368B likewise can include a second fluid control valve 320B. The first bypass branch 358A can similarly include a suction fluid control valve 320C. Thus, depending on the configuration of the system 200 and the operation of the system 200, various segments of the tubing 368A, 358A, 358B, and 368B can be isolated by the valves 320A, 320B, and / or 320C.

[0283] The drip chamber 354 can be disposed between the first tube segment 368A and the second tube 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.

[0284] The inlet tube 108B can be connected to the second cassette port 360B and can connect the soft cassette 340 to the flexible circuit 524. The inlet tube 108B can also include a sensor 808 disposed on or in the tubing 108B that is disposed with the tubing 108B prior to connection with the system static circuit connector 528 of the flexible circuit 524. The pressure sensor (CPS) 808 can detect (but is not limited to) one or more of: pressure, the presence of fluid or air, and / or another possible characteristic of the fluid in the tubing 108B. Further, the suction pump 208 can cause fluid to be pumped away from or to the soft cassette 340 through the tubing 108B.

[0285] Two or more different conduits can be connected to the flexible circuit 524 through the system static circuit connector 528 and provide fluid to or receive fluid from the blood component collection bag 536. An outlet tube 112 exits the system static circuit connector 528 from the flexible circuit 524. This outlet tube 112 can also include another line sensor 812 disposed thereon or therein to detect fluid, air, cell concentration, color, and / or color change in the fluid from the flexible circuit 524; the line sensor 812 can be the same as or similar in type and / or function to the previously described sensors 804, 312, 320, 808, and / or 284. A second CPS sensor 816 or fluid sensor can also be disposed in or on the tube 112. The sensor 816 can detect, but is not limited to, one or more of the following: presence of fluid, pressure within the tube 112, and / or other characteristics of the fluid in the tube 112. Similarly, the sensor 816 can be the same as or similar in type and / or function to the previously described sensors 804, 312, 320, 808, 812, and / or 284.

[0286] The outlet tube 112 can then flow into the plasma air detection sensor 284 before the saline and plasma tube y-connector 280 divides the outlet tube 112 into the saline tube 116 and the plasma tube 120. The return pump 212 can interact with the outlet tube 112 and can cause fluid or air to flow from the flexible circuit 524 or from the saline bag 118 and / or the plasma collection bottle 122 through the outlet tube 112.

[0287] The saline bag 118 and associated conduits 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 when processing or separating from whole blood. The plasma collection bottle 122 can be selectively isolated from the system by the plasma flow control valve 286.

[0288] Electrical and control system

[0289] According to embodiments of the present disclosure, embodiments of an electrical and control system 900 that controls the functions of the blood component separation system 200 can be as shown in FIG. 9 The control system 900 can include one or more nodes that can 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.

[0290] 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 FIG. 10 The centrifuge node 908 can be combined with FIG. 11 As stated.

[0291] 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 FIG. 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.

[0292] 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 FIG. 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。

[0293] According to an embodiment of the present disclosure, the embodiment of the box node 904 can be as follows FIG. 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.

[0294] 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 an NK10DN512VOK10 microcontroller manufactured and sold by N9P Incorporated of the United States, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are possible. The controller 1004 can control or manage the functions of other types of devices, such as the first fluid control valve 320A, the second fluid control valve 320B, the suction fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, etc. valves, as well as the pumps 936-944, etc. In addition, the controller 1004 can communicate with the various sensors 916-924 or other devices to receive or send information regarding the functions of the blood component separation system 200.

[0295] Other examples of processors or microcontrollers 1004 as described herein can 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 co-processor, series, Celeron TM series processor, series processor, Ryzen TM series processor, series processor, i5-4670K and i7-4770K 22nm Haswell, i5-3570K 22nm Ivy Bridge, FXTM series processor, FX-4300, FX-6300, and FX-8350 32nm Vishera, Kaveri processor, CortexTM-M processor, Cortex-A and ARM926EJ-STM processors, other industry equivalent processors, and other examples of the processor or microcontroller 1004 can perform computational functions using any known or future developed standard, instruction set, library, and / or architecture.

[0296] The memory 1008 can be any type of memory, including random access memory (RAM), read only memory (ROM), electrically erasable programmable ROM (EEPROM), compact disc read-only memory (CD-ROM), optical storage, magnetic storage, any suitable combination thereof, or other types of storage or memory that store and provide instructions to program and control the controller 1004, as described below. The memory 1008 can provide all types of software or firmware that program the functionality of the controller 1004, as described below.

[0297] The controller 1004 can be in communication with one or more valve controllers 1020. Each valve as described herein, such as the first fluid control valve 320A, the second fluid control valve 320B, the suction fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, and the like, 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, operational instructions, or power to close or open any one of the valves described herein, for example, 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 suction fluid control valve 320C, and the like.

[0298] The controller 1004 can also be connected to a bus 912, 932 (e.g., UART bus, CAN bus), or other bus through a transceiver 1012, 1016 disposed external to the controller 1004 or integrated to the controller 1004. The UART transceiver 1012 can communicate with one or more of the sensors 916-924 or other devices. Likewise, the CAN bus transceiver 1016 can communicate with one or more of the pump controllers 936-944 or other devices. The UART transceiver 1012, bus, CAN bus transceiver 1016, and bus are well known in the art and need not be further explained here.

[0299] According to embodiments of the present disclosure, embodiments of the centrifuge node 908 can be as described inFIG. 11 The centrifuge node 908 can include the same or similar types of components as the cassette node 904. For example, the centrifuge node 908 can include a controller 1104, a UART transceiver 1112, etc. Similar to the controller 1004, the controller 1104 can be any type of processor or microcontroller (e.g., the NK10DN512VOK10 microcontroller unit with a 32-bit architecture from N9P Incorporated, as previously described), or other controller, processor, etc. (e.g., the previously mentioned devices).

[0300] The controller 1104 can communicate with the sensors 916-924 through the UART transceiver 1112 or through other buses or systems directly. 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 that is used to accelerate or spin the centrifuge 400, or control the speed settings or other functions of the centrifuge 400.

[0301] In some configurations, the controller 1104 can also communicate with a cuff controller 1120, which can change or set the pressure of a pressure cuff on the donor’s arm during the blood component separation process. Additionally, the controller 1104 can communicate with and / or control a strobe light 1114, which can be any light that flashes at a periodicity that is synchronized with the rotational rate of the motor, such that an operator of the blood component separation system 200 can see the operation of the fill 460 as previously described. Thus, the controller 1104 can communicate with the strobe light 1114 to change the frequency of the flashing of the strobe light 1114, the intensity of the strobe light 1114, etc.

[0302] It should be appreciated that the cassette node 904 and the centrifuge node 908 include additional components that are described, for example, in U.S. Application No. 17 / 392,804, entitled “Methods and Systems for High Throughput Blood Component Collection,” filed August 3, 2021 (Attorney Docket No. 18955-000019-US), the entirety of which is incorporated by reference herein.

[0303] Exemplary code scanning and data control method

[0304] In at least one example embodiment, as FIG. 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.

[0305] In at least one exemplary embodiment, FIG. 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: FIG. 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 FIG. 12C Label 1227 is shown on bottle 1224 used for plasma collection.

[0306] 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.

[0307] 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), cell phone, tablet, etc.), a blood component collection set (e.g., a separation set), and / or a plasma collection bottle, without further input by the user through a user interface. The system is able to automatically receive the information and confirm the data input without the need for human input. It is appreciated that this automatic sequential input of data improves the speed of operation as compared to traditional non-sequential input.

[0308] Data received from the donor can include biometric information, such as age, weight, height, donor history, or other information that can be relevant to the donation process. The data received from the donor can be used to determine whether the donor is eligible for a donation procedure, and to determine particular settings that can be required for the donation procedure, such as an expected total volume 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 a target volume or amount of plasma to be collected.

[0309] In at least one example embodiment, information can be transferred between donation sites, blood component separation systems 200, locations, etc. The information can be stored in the form of a line graph, such as a two-dimensional bar code. In this manner, 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.

[0310] Information stored in the line graph and able to be read 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., according to privacy laws, health laws, etc.). In at least one example embodiment, other private information can be stored in the two-dimensional bar code, but can be encrypted or locked to prevent being read by the integrated identification reader of the blood component separation system 200.

[0311] The blood component separation system 200 can scan or read the barcode and then determine which operations to perform. For example, the barcode can 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 weight that is heavier can be allowed to donate a second amount of plasma that is greater than the first amount of plasma. Further, 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, the blood component separation system 200 can be able to adjust the settings in accordance with this information and stop the operation when the desired amount of plasma, etc. has been collected.

[0312] The blood component separation system 200 can also be able to write information that can be read by other blood component separation systems at the same or other donation sites. For example, donor data can be stored at a network location. The blood component separation system 200 can be able to send data such as the results of the donation, the current weight of the donor, the date and / or time of the donation, or other information.

[0313] In at least one example embodiment, the blood component separation system 200 can include one or more computer systems. For example, as will be discussed in greater detail below with reference to FIG. 16D As will be discussed in greater detail below with reference to

[0314] In at least one example embodiment, the blood component separation system 200 can be able to communicate with a server 1621 via a network 1618 such as the Internet, as will be discussed in greater detail below with reference to FIG. 16B As will be discussed in greater detail below with reference to

[0315] In at least one example embodiment, after receiving data associated with a donor, the blood component separation system 200 can be able to adjust the settings of the blood component separation system 200, as will be discussed in greater detail below with reference to FIG. 12B and FIG. 12DThe feedback system of the illustrated graphical user interface (GUI) 1230 confirms that the data associated with the donor has been received. In this way, a nurse, doctor, or other user of the blood component separation system 200 can be able to quickly determine whether the donor information has been properly entered into the blood component separation system 200. In at least one example embodiment, the feedback system can also or alternatively include a speaker that can be configured to provide audible feedback.

[0316] At step 1206, the blood component separation system 200 can be configured to determine the identification (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 a database or whether the donor is a new donor. In at least one example embodiment, the scanner 1221 can access the donor information from a server or other computer system, either locally or via a network connection.

[0317] The donor ID information accessed through the database can include information received from the donor, such as age, body mass, weight, height, and / or target volume (i.e., the expected amount of plasma or other donated fluid).

[0318] At step 1209, the blood component separation system 200 can receive data associated with the blood component collection device. The blood component collection device may, for example, include a soft pack assembly, such as the soft pack assembly 300, used during the donation process. The data associated with the blood component collection device can be received by the blood component separation system 200 through a barcode, QR code, RFID chip, or other type of scannable object that can be placed in the blood component collection device. For example, each blood component collection device can have a label or sticker attached that can 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 can be able to record which blood component collection device is being used for the current donation process into memory. In this way, the blood component separation system 200 can be able to associate the donor with the blood component collection device. Any data received during the scanning process can be recorded into memory and shared with a server or other type of computing system.

[0319] Data associated with the blood component collection set can include a date of production, an identity of the manufacturer, and other information that can be used for data processing after donation is complete. In at least one example embodiment, scanning the received data associated with the blood component collection set can be used to determine a type of the blood component collection set. The type of the blood component collection set can be used by the blood component separation system to adjust one or more settings, such as flow rates or other information during the donation process.

[0320] In at least one example embodiment, after scanning the blood component collection set, the user of the blood component separation system 200 can be able to receive a confirmation of receipt of information from the blood component collection set. For example, as shown in the graphical user interface 1230 can display an indication of whether data from the blood component collection set has been received. Such a graphical user interface 1230 can be used by an operator of the blood component separation system during the process of initializing the blood component separation system for a new donor. In at least one example embodiment, as an alternative or in addition to display through a graphical user interface, the blood component separation system can play an audible sound through one or more speakers or a display light of various colors to indicate that data has been received. FIG. 12D

[0321] At step 1212, the method can include receiving, by the blood component separation system 200, data associated with the plasma collection bottle. For example, a plasma collection bottle can be needed in order to initialize the blood component separation system 200 for a new donor. After donation, the plasma collection bottle can be filled with donated plasma. For data tracking purposes, the plasma collection bottle can need to be associated with the donor. For example, information linking the donor to the plasma collection bottle can be stored in memory. Thus, it can be desirable to record the identity of the plasma collection bottle. Accordingly, a user of the blood component separation system 200 can be able to scan, using the blood component separation system 200, a label, sticker, or other object on or printed on the plasma collection bottle. For example, as shown in FIG. 12B, the plasma collection bottle 1224 can have a sticker or label 1227 affixed thereto. In some example embodiments, the sticker or label 1227 includes a QR code. FIG. 12C

[0322] As with the other steps, upon 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 display light of white color, or other feedback system.

[0323] ​​At step 1215, the blood component separation system can execute a plasma donation process based on the information received in the above steps. For example, the blood component separation system 200 can use the information about the identity of the donor to execute the plasma donation process. The plasma donation process can also utilize data received from the plasma collection bottle and / or the blood component.

[0324] For example, one or more of the body mass and weight of the donor is determined based on the received data associated with the donor, and the flow rate in the plasma donation process is controlled based on the one or more of the body mass and weight of the donor. One or more of the body mass and weight of the donor can also be determined based on the received data associated with the donor, and the volume of plasma collected is controlled based on the one or more of the body mass and weight of the donor.

[0325] At step 1218, the process can end, at which point the donation process can continue, completing the extraction of fluid from the donor. Any data received through the above steps can be recorded to memory and / or shared with one or more computer systems. For example, a database entry can be created for the particular donation, including the amount or volume of plasma extracted from the donor, the current weight of the donor, the time and / or date of the donation, and / or other information.

[0326] At least one example embodiment of the present disclosure includes a method comprising: receiving, by a blood component separation system, data associated with a donor; determining, by the blood component separation system, an identity of the donor based on the data associated with the donor; receiving, by the blood component separation system, data associated with a blood component collection device; receiving, by the blood component separation system, data associated with a plasma collection bottle; and executing, by the blood component separation system, a plasma donation process 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.

[0327] Aspects of the above embodiments include that receiving the data associated with the donor includes scanning an image with a scanner. Aspects of the above embodiments include that the scanner is disposed on the blood component collection system. Aspects of the above embodiments include that the image is one of a one-dimensional barcode or a two-dimensional barcode. Aspects of the above embodiments include that the image is displayed on the user device. Aspects of the above embodiments include that receiving the data associated with the donor includes scanning an RFID. Aspects of the above embodiments include that, after receiving the data associated with the donor, confirming receipt of the data associated with the donor via a feedback system. Aspects of the above embodiments include that the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include that determining, based on the data associated with the donor, that the donor is a new donor. Aspects of the above embodiments include that determining, based on the data associated with the donor, one or more of a body mass and a body weight of the donor. Aspects of the above embodiments include that receiving the data associated with the blood component collection set includes scanning one or more of an image and an RFID attached to the blood component collection set with a scanner. Aspects of the above embodiments include that, after receiving the data associated with the blood component collection set, confirming receipt of the data associated with the blood component collection set via a feedback system. Aspects of the above embodiments include that the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include that receiving the 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 that, after receiving the data associated with the plasma collection bottle, confirming receipt of the data associated with the plasma collection bottle via a feedback system. Aspects of the above embodiments include that the feedback system includes one or more of a speaker and a graphical user interface. Aspects of the above embodiments include that determining, based on the received data associated with the donor, one or more of a body mass and a body weight of the donor, thereby controlling a flow rate during the plasma donation process based on the one or more of the body mass and the body weight of the donor.

[0328] Exemplary calibration, maintenance, and service of a blood component separation system

[0329] The blood component collection system 200 can include one or more devices, systems, and / or features configured to allow the blood component collection system 200 to be calibrated in the field. For example, the blood component collection system 200 can include one or more devices, systems, and / or features configured to allow the blood component collection system 200 to be calibrated in the field. In other words, the blood component collection system 200 can be calibrated after manufacture and after installation at a donor processing location. Conventional systems are unable to be calibrated in the field.

[0330] 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 sets a calibration pressure using pressure supplied from, for example, a compressor integrated with the blood component separation system 200. In other embodiments, the compressor can 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 configured to generate a known or calibration pressure using, for example, the pump and the compressor. In at least one exemplary embodiment, the test port is located on a dorsal side of the blood component separation system 200 adjacent to other ports such as a pressure cuff connection that can change or set the pressure of a pressure cuff on a donor’s arm during a blood component separation process, as described above with respect to FIG. 11 The tubing, calibration tube set, etc. of the blood component collection circuit 520 can be attached or otherwise interconnected to the test port for testing and / or calibration. When interconnected with the test port, the compressor generates a known calibration pressure and a 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 to the detected pressure and the difference can be used to calibrate the pressure sensor. The pressure sensor can be located, for example, at the test port or can be located anywhere in the blood component separation system 200.

[0331] Calibration can also include checking and / or calibrating the holder using a calibration object having a known weight (e.g., a weight certified by the National Institute of Standards and Technology (NIST)), for example FIG. 13A the holder 1300 shown and / or FIGS. 15A-15C the bottle tray weigh sensor assembly shown, which will be discussed in more detail below. In at least one exemplary embodiment, the holder 1300 can be configured to receive a plasma collection bottle 122. The holder 1300 can be disposed on the top cover 210 of the housing 204 and can be similar to, for example, the holder 1300 shown in FIGS. 13A and 13B. The holder 1300 can be configured to receive a plasma collection bottle 122. The holder 1300 can be disposed on the top cover 210 of the housing 204 and can be similar to, for example, the holder 1300 shown in FIGS. 13A and 13B. FIG. 14AA plasma collection tray 232C is shown. The holder 1300 can include a weight sensor configured to sense a weight of an object placed on the holder 1300. As such, during a calibration process, a calibration object can be placed on the holder 1300 and the weight sensor can detect a detected weight of the calibration object. A difference between the known weight of the calibration object and the detected weight detected by the weight sensor can indicate that the weight sensor can need to be calibrated (which can be automatically triggered by the difference) or serviced. In at least one example embodiment, if the difference is greater than a predetermined threshold, the blood component separation system 200 can automatically trigger a calibration of the weight sensor. In other embodiments, if the difference is greater than a predetermined threshold, a notification can be generated to alert a user to calibrate the weight sensor.

[0332] One or more calibration tests and / or calibrations can be performed when one or more components on the blood component separation system 200 are replaced or exchanged. For example, replacing or exchanging 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 fail the one or more calibration tests, a 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 out and can not be used until each component passes its respective calibration test.

[0333] FIG. 13B The method 1302 of performing calibration tests and calibrations shown in the flowchart of FIG. 13 can begin at step 1304. Upon beginning of the method 1302, one or more calibration tests can be performed or implemented. The one or more calibration tests can be automatically triggered by replacing or exchanging 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 example embodiments, the one or more calibration tests can be triggered by a user input. In still other example embodiments, the calibration tests can be performed prior to use of the blood component separation system 200.

[0334] At step 1306, one or more components of the system (e.g., calibration tubing, sensors, pumps, etc.) can be automatically calibrated. The calibration can be triggered by, for example, a failure of at least one of the one or more tests performed in step 1304. In other example embodiments, the calibration can be triggered by a user input. The calibration can be performed using one or more calibration tools (e.g., pumps, test ports, calibration objects, etc.). The calibration can cause a user interface, such as a GUI, to alert a user to connect one or more calibration tools or components for the calibration.

[0335] It should be appreciated that steps 1304 and 1306 can be repeated (whether individually or together). For example, at step 1304, a certain component can fail a calibration test, the component can be automatically calibrated at step 1306, and the component can be retested at step 1304 to test whether the component is properly calibrated.

[0336] The blood component separation system 200 can also include one or more protocols to provide service / technical support for the device. These protocols can include calibration (as described above), automatic testing (e.g., test limits and full range), fluid run (with actual parameters), etc. In at least one example embodiment, a saline check can be performed. In such an embodiment, the blood component separation system 200 can include a weight sensor configured to sense the weight of the plasma collection bottle 122. Saline can be moved from the saline bag 118 to the plasma collection bottle 122, and a change in weight of the plasma collection bottle 122 can be detected by the weight sensor. This change in weight 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 example embodiment, a disposable test can be performed to check whether the blood component collection set 500 is leaking. In such an embodiment, the blood component separation system 200 can include a pump configured to create a vacuum in the blood component collection set 500. The blood component separation system 200 can also include a sensor to detect such a leak in the blood component collection set 500. In at least one example embodiment, a centrifuge test can be performed to test the centrifuge assembly 400. In such an embodiment, the motor of the rotor and motor assembly 414 can be activated to verify proper rotation of the centrifuge assembly 400.

[0337] Exemplary mobile circuit holder

[0338] FIGS. 14A-14F A mobile circuit holder 1400 included in the blood component separation system 200 is shown. As shown, the mobile circuit holder 1400 can be disposed at least partially within a centrifuge chamber 1402 of the blood component separation system 200. The centrifuge chamber 1402 is defined as an interior space of the blood component separation system 200 in which the centrifuge assembly 400 is housed, e.g., behind the access plate 224. As shown, the mobile circuit holder 1400 can be arranged above the centrifuge assembly 400 (e.g., offset from the centrifuge assembly 400 in the positive z-axis direction). The mobile circuit holder 1400 can correspond to the fixed circuit connection 402 or a portion of the fixed circuit connection 402 as described above. FIG. 14B

[0339] ​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, FIG. 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.

[0340] 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, FIGS. 14A-14B and FIG. 14D ) and the second state or loaded state or restricted state (see for example FIG. 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.

[0341] In at least one exemplary embodiment, for example FIG. 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 FIG. 4D 、 FIG. 4E and FIG. 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. FIG. 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.

[0342] In at least one example 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 operational state and the loading 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. To move the centrifuge assembly 400 between the operational state and the loading 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, as shown in FIG. 14C the retracted circuit holder 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 holder body 1408 and the fill opening pivot arc 1410. The fill opening pivot arc 1410 can correspond to a path associated with an outermost portion of the upper housing 404B as the upper housing 404B is hinged about the split housing pivot axis 406 (e.g., relative to the lower housing 404A, etc.). When the mobile circuit holder 1400 is in the retracted state 1400B, the upper housing 404B can be hinged relative to the lower housing 404A without contacting the circuit holder body 1408.

[0343] In at least one example embodiment, the blood component separation system 200 can be inoperable when the mobile circuit holder 1400 is in the retracted state 1400B. The blood component separation system 200 can only be permitted to operate when the mobile circuit holder 1400 is in the extended state. For example, the blood component separation system 200 can include one or more sensors configured to detect a position of the mobile circuit holder 1400, and based on the detected position, provide an input to the blood component separation system 200 including information about the mobile circuit holder 1400 position. In response, a controller can restrict operation of the blood component separation system 200 when the mobile circuit holder 1400 is in the retracted state, and can permit operation of the blood component separation system 200 when the mobile circuit holder 1400 is in the extended state.

[0344] By moving the mobile circuit holder 1400 to the retracted state 1400B and hinging the upper housing 404B to the loading position (e.g., see FIG. 4F and 6A), a portion of the blood component collection set 500 can be loaded into the blood component separation system 200. In at least one example embodiment, when the upper housing 404B is open and in a loading state, at least a portion of the upper housing 404B can extend outside of the centrifuge chamber 1402. In this“upside down” loading state, the inverted upper housing 404B can provide clearance and accessibility to load the blood component collection pouch 536 into the fill pack 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 fill pack 460, the upper housing 404B can be articulated from the loading state to an operating state (e.g., see FIG. 6C ). In this position, the mobile circuit holder 1400 can be moved from the retracted state 1400B to an extended state (e.g., see FIG. 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 fill pack 460 can be performed by reversing the order of the above-described operations. For example, unloading the fill pack 460 and / or the centrifuge assembly 400 can include decoupling 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 articulated from the operating position to an open loading position. In the open position, the blood component collection circuit 520 can be disconnected and removed from the fill pack 460. The loading and unloading processes can be repeated between uses or operations of the blood component separation system 200 to reload the fill pack 460 and / or the centrifuge assembly 400.

[0345] In at least one example embodiment, the present disclosure provides a blood component separation system. The blood component separation system can include a housing having a front side and a back 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, where the mobile circuit holder includes a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space can be sized to accommodate a connector of a flexible circuit. The mobile circuit holder can be movable between an extended state within the centrifuge chamber, where the circuit holder body is arranged offset a first distance from the centrifuge assembly, and a retracted state within the centrifuge chamber, where the circuit holder body is arranged offset a second distance from the centrifuge assembly, and the second distance is greater than the first distance. In at least one example embodiment, the centrifuge assembly can include a centrifuge housing that can include a loaded state and an operational state. The centrifuge housing can be prevented from moving from the operational state to the loaded state when the mobile circuit holder is in the extended state, and the centrifuge housing can be permitted to move from the operational state to the loaded state when the mobile circuit holder is in the retracted state. In at least one example embodiment, the centrifuge housing can include a split housing that includes a lower housing portion and an upper housing portion, where the upper housing portion is hinged relative to the lower housing portion and articulates along an arc when moving between the operational state and the loaded state. In at least one example embodiment, a gap space can be disposed between the circuit holder body and the arc when the mobile circuit holder is in the retracted state so as to provide a path of movement along the arc for the upper housing portion to articulate relative to the lower housing portion between the operational state and the loaded state, clear of the circuit holder body. In at least one example embodiment, the gap space between the circuit holder body and the arc can be removed when the mobile circuit holder is in the extended state, which can prevent the upper housing portion from articulating relative to the lower housing portion between the operational state and the loaded state. In at least one example embodiment, the circuit holder body can be disposed closer to the back side of the housing when the mobile circuit holder is in the retracted state than when the mobile circuit holder is in the extended state. In at least one example embodiment, the circuit holder body can include a connector lock that engages the connector of the flexible circuit to thereby lock the flexible circuit relative to the circuit holder body and the circuit connection space. In at least one example embodiment, the mobile circuit holder can include a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space can be sized to accommodate a connector of a flexible circuit of a blood component collection set.The movable circuit holder can be movable between an extended state within a centrifuge chamber of the blood component separation system and a retracted state within the centrifuge chamber, where in the extended state the circuit holder body is disposed a first distance from a centrifuge assembly disposed within the centrifuge chamber, and in the retracted state the circuit holder body is disposed a second distance from the centrifuge assembly disposed within the centrifuge chamber. The second distance can be greater than the first distance. In at least one example 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.

[0346] In at least one example embodiment, a method of loading a centrifuge fill of a blood component separation system is provided. The method can include providing a blood component separation system including a housing having a front side and a back 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. The centrifuge assembly can have a split housing including a lower housing portion and an upper housing portion, where the upper housing portion is hinged relative to the lower housing portion. The centrifuge housing can have a loaded state and an operational state. The mobile circuit holder can include a circuit holder body and a circuit connection space disposed in the circuit holder body. The circuit connection space can be sized to accommodate a connector of a flexible circuit. The mobile circuit holder can be movable between an extended state within the centrifuge chamber, where the circuit holder body can be disposed offset a first distance from the centrifuge assembly, and a retracted state within the centrifuge chamber, where the circuit holder body is disposed offset a second distance from the centrifuge assembly. The second distance can be greater than the first distance. The upper housing portion can be hinged along an arc when moving between the operational state and the loaded state, where the split housing can be prevented from moving from the operational state to the loaded state when the mobile circuit holder is in the extended state, and the split housing can be allowed to move from the operational state to the loaded state when the mobile circuit holder is in the extended state. The method of loading the centrifuge fill can further include actuating a release catch to unlock the mobile circuit holder from a locked state to an unlocked state, moving the mobile circuit holder from the extended state to the retracted state, hinging the upper housing portion relative to the lower housing portion when the mobile circuit holder is in the retracted state such that the upper housing portion is disposed at least partially outside of the centrifuge chamber and the upper housing portion is in the loaded state, coupling a blood component collection pod and a flexible circuit of a blood component collection device with a fill disposed in the upper housing portion when the upper housing portion is in the loaded state, hinging the upper housing portion relative to the lower housing portion when the mobile circuit holder is in the retracted state such that the upper housing portion is disposed within the centrifuge chamber and the upper housing portion is in the operational state, and moving the mobile circuit holder from the retracted state to the extended state such that the release catch locks the mobile circuit holder in the locked state.

[0347] Exemplary bottle tray with magnetic coupler and load cell overload protection

[0348] FIGS. 15A-15M Various views of a load cell assembly and components thereof are shown in accordance with at least one example embodiment. FIG. 15A is a perspective view of a load cell assembly in accordance with at least one example embodiment. FIG. 15B is a perspective view of a load cell assembly in accordance with at least one example embodiment. FIG. 15A is an exploded perspective view of a load cell assembly in accordance with at least one example embodiment.

[0349] In at least the illustrated example embodiment, the load cell assembly 1500 is a bottle tray load cell assembly. The load cell assembly 1500 includes a fixed portion, a deflection portion (1512, 1514, 1516) and a load cell 1506. In at least one example 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 example 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 bar”), and a cradle 1516 (also referred to as a “bottle cradle” or a “plasma collection cradle”). The load cell assembly 1500 can extend along a central or longitudinal axis 1517. In at least one example embodiment, the longitudinal axis 1517 passes through the center of the load cell 1506. FIG. 15B In at least one example embodiment, the cradle 1516 can be similar to the plasma collection cradle 232C in

[0350] FIG. 2A In at least one example embodiment, the cradle 1516 can be similar to the plasma collection cradle 232C in FIG. 1 The plasma collection cradle 1516 can be attached to the overload support bar 1514. As described above, the plasma collection cradle 1516 can be configured to receive, orient and / or hold a container (such as a plasma collection bottle, for example, the bottle 1598 in FIG. 15M or the container 2716 in FIG. 26J In at least one example embodiment, the load cell 1506 is configured to deflect and sense the load and / or weight of the container. The load cell 1506 can be sensitive to forces within a predetermined (or desired) range. For example, when the force applied to the load cell 1506 is outside (e.g., exceeds) the predetermined range, the accuracy of the load measurement and / or the integrity of the load cell 1506 can be compromised.

[0351] In at least one example embodiment, the cradle 1516 is coupled to the load cell 1506 via a magnetic force coupling and interface. The magnetic force coupling can be configured to mechanically decouple the cradle 1516 from the load cell 1506, thereby reducing or preventing mechanical forces from continuing to be applied to the flexure beam and / or the load cell 1506. In at least one example embodiment, as will be described in greater detail below, upon reaching a predetermined load amount, the cradle 1516 can break the magnetic interconnection force that separates the cradle 1516, the plate 1508 and the second component 1514 from the blood component separation system 200. In addition to this, the magnetic interconnection force can reduce or prevent damage to the load cell 1506, sensing components, support elements, flexure beams and / or other mechanical elements disposed between the cradle 1516 and the load cell 1506. ​

[0352] In at least one example embodiment, the first component 1512 includes a first magnet 1518 and the second component 1514 includes a second magnet 1520. The first magnet 1518 can be coupled to the first component 1512 by a first fastener 1522A. The second magnet 1520 can be coupled to the second component 1514 by a second fastener 1522B. As will be described in greater detail below, the load cell 1506 can be coupled to the bracket 1510 by one or more third fasteners 1522C. The first component 1512 can be coupled to the load cell 1506 by one or more fourth fasteners 1522D. The mounting plate 1508 can be coupled to the bracket 1510 by one or more fifth fasteners 1522E. The second component 1514 can be coupled to the cradle 1516 by one or more sixth fasteners 1522F. In at least one example embodiment, the fastener 1522A, the fastener 1522B, the fastener 1522C, the fastener 1522D, the fastener 1522E, the fastener 1522F can be independently selected from a flat head screw, an internal hex screw, a bolt, and the like.

[0353] FIG. 15C is a top perspective view of a mounting plate of a load cell assembly in FIG. 15A according to at least one example embodiment. FIG. 15D is a bottom perspective view of the mounting plate in FIG. 15C according to at least one example embodiment.

[0354] In at least one example embodiment, as shown in FIGS. 15C-15D , the mounting plate 1508 includes a substantially planar body 1524 having a first side 1526A and a second side 1526B. The planar body 1524 can define a generally rectangular perimeter (e.g., a rectangle with rounded corners).

[0355] In at least one example embodiment, the planar body 1524 defines one or more first holes 1528 (e.g., four holes 1528 as shown). Fasteners (not shown) can extend through the first holes 1528 to couple the load cell assembly 1500 (as shown in FIGS. 15A-15B ) to the blood component separation system 200 (as shown in FIG. 1 A) via the mounting plate 1508. In at least one example embodiment, the bottle 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 servicing of the bottle tray load cell assembly 1500 and / or any components of the bottle tray load cell assembly 1500, as will be described in greater detail below in the discussion of FIG. 18A .

[0356] In at least one example embodiment, a first flange 1530 extends from the planar body 1524 on a first side 1526A. The first flange 1530 can be defined as a rectangular shape. In at least one example embodiment, the mounting plate 1508 includes a gasket 1532 (as shown in FIG. 15B) on the first side 1526A. The gasket 1532 can be adjacent to the first flange 1530. When the load cell assembly 1500 (as shown in FIG. 15A) is coupled to the blood component separation system 200 (as shown in FIG. 15A), the gasket 1532 is positioned between the planar body 1524 of the plate 1508 and the housing 204 (as shown in FIG. 15A). In at least one example embodiment, the gasket 1532 can be or include an O-ring, a flat gasket, or another flexible sealing member. Additionally or alternatively, the gasket 1532 can be or include an electromagnetic interference (EMI) shielding gasket (e.g., a metal gasket, a spring, a metalized gasket, etc.). FIG. 15D FIGS. 15A-15B FIG. 1 FIG. 2A

[0357] In at least one example embodiment, the planar body 1524 defines a second hole 1534. The second hole 1534 can be a center hole. In at least one example embodiment, a second flange 1536 can extend from a 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 example embodiment, a portion of the second component 1514 (as shown in FIG. 15B) extends through the second hole 1534. The second component 1514 can be configured to translate along the longitudinal axis 1517 when the deflection portion (as shown in FIG. 15B) of the load cell assembly 1500 deflects. In at least one example embodiment, the deflection amount 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). FIGS. 15A-15B FIGS. 15A-15B

[0358] FIG. 15E is a perspective view of a bracket of a load cell assembly in FIG. 15A according to at least one example embodiment.

[0359] In at least one example embodiment, as FIG. 15E ​​​​​​As shown, the bracket 1510 includes a wall 1538 and a third flange 1540. The third flange 1540 can include a first flange portion 1540A and a second flange portion 1540B. The first flange portion 1540A and the second flange portion 1540B can be spaced apart from one another. The first flange portion 1540A and the second flange portion 1540B can include respective upper surfaces 1541A, 1541B. The upper surfaces 1541A, 1541B can be coplanar.

[0360] In at least one example embodiment, the wall 1538 defines a containment slot 1542. The containment slot 1542 can be defined in a generally rectangular shape. The containment 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 FIG. 15I shown.

[0361] The wall 1538 can also define a recess 1543. The recess 1543 can be defined in a semi-cylindrical shape. The recess 1543 can extend between the containment slot 1542 and an upper surface 1544 of the wall 1538. The recess can receive at least a portion of the overload support rod 1514, as FIG. 15I shown.

[0362] In at least one example embodiment, the bracket 1510 can also include a gusset 1546 extending between the wall 1538 and the third flange 1540. In at least one example embodiment, the wall 1538, the third flange 1540, and the gusset 1546 can cooperate to define an internal bracket region 1547. As will be described in greater detail below, in at least one example embodiment, the load cell 1506, the first component 1512, and a portion of the second component 1514 can be in the internal bracket region 1547. Thus, when the mounting plate 1508 is attached to the housing 204 of the blood component separation system 200 (as FIG. 2A shown), the bracket 1510 can be within a protected portion of the blood component separation system 200 (e.g., to protect the load cell 1506 and / or other components of the load cell assembly 1500 from damage, tampering, and / or the environment outside of the blood component separation system 200, etc.).

[0363] 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., FIGS. 15A-15B ) is coupled to bracket 1510, as will be described in more detail below.

[0364] FIG. 15F According to at least one exemplary embodiment FIG. 15A A perspective view of the load cell in the load cell assembly.

[0365] In at least one exemplary embodiment, FIG. 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). FIG. 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.

[0366] 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. FIG. 15A and FIG. 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.

[0367] 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.

[0368] Back to FIGS. 15A-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. FIG. 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 .

[0369] FIG. 15G According to at least one exemplary embodiment FIG. 15A A perspective view of the load interface plate of the load support assembly in FIG.

[0370] In at least one exemplary embodiment, FIG. 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., FIG. 15A As shown), the load interface axis 1517A can be aligned with the center axis 1517 (as shown). FIG. 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. FIG. 15BThe first magnet 1518 can be glued, pinned, crimped, or otherwise fastened within the first recess 1566. In at least the illustrated example embodiment, the first magnet 1518 can be attached to the overload support bar 1514 via a first fastener 1522A, such as a flat head cap screw. In at least one example embodiment, a surface of the first magnet 1518 can be disposed flush with or below a first cam surface 1567 of the overload support bar 1514.

[0371] In at least one example embodiment, the first cam surface 1567 defines a plurality of valleys 1568. In at least the illustrated example embodiment, the plurality of valleys 1568 includes a first valley 1568A, a second valley 1568B, and a third valley 1568C. The valleys 1568 can be disposed asymmetrically about the load interface axis 1517A (e.g., having centers disposed about 90° apart from one another). In at least one example embodiment, each valley 1568 can be configured as a rest or recess having at least one sloped, beveled, or tapered side.

[0372] In at least one example embodiment, the first cam surface 1567 can further define a first flat portion 1569. In the illustrated example embodiment, the first flat portion 1569 is located between the first valley 1568A and the third valley 1568C. The first flat portion 1569 can extend uninterrupted between the first valley 1568A and the third valley 1568C. The valleys 1568A, 1568B, 1568C, and the first flat portion 1569 can circumferentially surround the first recess 1566.

[0373] In at least one example embodiment, the second side 1564B of the first cam body 1560 can further define a plurality of notches 1570. Each notch 1570 can correspond to a respective valley 1568. The notches 1570 can be located at a center of each respective valley 1568.

[0374] The extension 1562 can be adjacent to the first cam body 1560. In at least the illustrated example embodiment, the extension 1562 defines a generally rectangular cross-section. The extension 1562 can define one or more fourth apertures 1571. The fourth apertures 1571 can accommodate fourth fasteners 1522D to couple the load interface plate 1512 to the load cell 1506 (as FIG. 15B illustrated).

[0375] FIG. 15H is a perspective view of an overload support bar of a load cell assembly in a load scale according to at least one example embodiment. FIG. 15A is a perspective view of an overload support bar of a load cell assembly in a load scale according to at least one example embodiment.

[0376] Referring to FIG. 15H In at least one example embodiment, the overload support rod 1514 includes a mandrel 1572 extending from a first end 1573A to a second end 1573B along a longitudinal or support rod axis 1517B (e.g., coinciding with the axis 1517 in FIG. 15A FIG. 1). In at least one example embodiment, the overload support rod 1514 includes a second cam body 1574 at the first end 1573A and a coupling portion 1575 at the first end 1573A.

[0377] In at least one example embodiment, the coupling portion 1575 has a diameter that is greater than a diameter of the mandrel 1572. The coupling portion 1575 can define a receiving slot, such as a fifth aperture 1575A. The fifth aperture 1575A can cooperate with a sixth fastener 1522F to couple the cradle 1516 (as shown in FIG. 15A FIG. 1) to the overload support rod 1514.

[0378] In at least one example embodiment, the second cam body 1574 is substantially cylindrical. The second cam body 1574 can define a second recess or second indentation 1576. The support rod axis 1517B can extend through a center of the second recess 1576. The support rod axis 1517B can be aligned with the central axis 1517 when the load cell assembly 1500 (as shown in FIG. 15A FIG. 1) is assembled. A second magnet 1520 can be at least partially in the second recess 1576. The second magnet 1520 (as shown in FIG. 15B FIG. 1) can be glued, pinned, crimped, or otherwise fastened within the second recess 1576. In at least the example embodiment shown, 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 example embodiment, a surface of the second magnet 1520 can be disposed flush with or below a second cam surface 1577 of the overload support rod 1514.

[0379] In at least one example embodiment, the second cam surface 1577 defines a plurality of lobes 1578. In at least the example embodiment shown, the plurality of lobes 1578 includes a first lobe 1578A, a second lobe 1578B, and a third lobe 1578C. The lobes 1578 can be disposed asymmetrically about the support rod axis 1517B (e.g., having centers disposed about 90° apart from one another). In at least one example embodiment, each lobe 1578 can be configured as a protrusion having at least one sloped or tapered side extending from a tip of the protrusion.

[0380] 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.

[0381] In at least one exemplary embodiment, the convex corners 1578 and the concave valleys 1568 (e.g., FIGS. 15G-15H 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.

[0382] In at least one exemplary embodiment, referring to FIG. 15G , valley 1568 (e.g. FIG. 15H 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. FIG. 15A 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.

[0383] 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 FIG. 15I 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.

[0384] FIG. 15A According to at least one exemplary embodiment FIG. 15J A partial cross-sectional view of the load cell assembly in the engaged state. FIG. 15A According to at least one exemplary embodiment FIGS. 15I-15J A partial cross-sectional view of the weighing sensor assembly in a disengaged state, wherein a portion of the first magnet is cut away.

[0385] In at least one exemplary embodiment, FIG. 15I 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.

[0386] When the overload support rod 1514 receives a predetermined movement and / or force, the overload support rod 1514 is moved FIG. 15J The engagement state shown and FIG. 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.

[0387] In at least one exemplary embodiment, FIG. 15I 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.

[0388] 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). FIG. 15K 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.

[0389] FIG. 15A According to at least one exemplary embodiment FIG. 15K Side elevation view of the bracket for the load cell assembly.

[0390] In at least one exemplary embodiment, FIG. 15MAs shown, the cradle 1516 includes a wall 1586 that at least partially defines a container region 1587. The wall 1586 can be partially cylindrical. A cover 1588 can be coupled to the wall 1586 to facilitate alignment and / or retention of a container within the container region 1587. In at least one example embodiment, the cover 1588 facilitates proper removal of a container (e.g., see container 1598) from the cradle 1516 by lifting a port end or top of the container prior to the bottom of the container, thereby reducing or preventing leakage of the contents of the container from the venting port of the container. FIG. 15A

[0391] The wall 1586 can extend between a first end 1586A and a second end 1586B. In at least one example embodiment, the second end 1586B of the wall 1586 includes a pair of alignment surfaces 1589. An alignment angle 1590 can be defined between the alignment surfaces 1589. In at least one example embodiment, the alignment angle 1590 is greater than or equal to about 90° (e.g., greater than or equal to about 100°, greater than or equal to about 110°, greater than or equal to about 120°, greater than or equal to about 130°, greater than or equal to about 140°, or greater than or equal to about 150°). The alignment angle 1590 can be less than or equal to about 160° (e.g., less than or equal to about 150°, less than or equal to about 140°, less than or equal to about 130°, less than or equal to about 120°, less than or equal to about 110°, or less than or equal to about 100°). The alignment surfaces 1589 can at least partially cooperate to define an alignment region 1591. In at least one example embodiment, the wall 1586 further defines a slot 1592 between the alignment surfaces 1589. In at least one example embodiment, the alignment surfaces 1589 and / or the slot 1592 can facilitate proper alignment of a container within the cradle 1516, as will be described in greater detail below.

[0392] In at least one example embodiment, the wall 1586 defines one or more receiving slots 1586C. The receiving slots 1586C can be configured to receive at least a portion of a calibration weight. In at least the illustrated example embodiment, the receiving slots 1586C are sized and shaped to receive a bottom portion of a cylindrical calibration weight. When the cylindrical calibration weight is at least partially within the receiving slots 1586C, a longitudinal axis of the cylindrical calibration weight is substantially parallel to a central axis 1517 (as shown) of the weighing sensor assembly 1500 (as shown). FIG. 15A FIG. 15L

[0393] FIG. 15K is a front elevation view of a cradle in a weighing sensor assembly in accordance with at least one example embodiment. FIG. 15L

[0394] In at least one example embodiment, as FIG. 15M ​​​​As shown, the cradle 1516 can be configured to hold the container in a desired orientation. The cradle 1516 can define a container angle 1594 between the bottom of the wall 1586 and a horizontal plane 1595 (i.e., a plane perpendicular to the direction of gravity). In at least one example embodiment, this 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°). This 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°).

[0395] FIG. 15K is a perspective view of a container in a cradle in accordance with at least one example embodiment. FIG. 15M

[0396] In at least one example embodiment, as shown in FIG. 16, the cradle 1516 is configured to hold the container in a desired orientation. In at least the example embodiment shown, the container is a bottle 1598. The bottle 1598 can be similar to or the same as the bottle 1900 in FIG. 19. FIG. 19A FIG. 19I The bottle 1598 can include a cap 1598A. The cap 1598A can include a protrusion 1598B including a pair of container alignment surfaces 1598C, a pair of side surfaces 1598D, and an opposing surface 1598E. The cap 1598A can also include a fluid port 1598F and a vent port 1598G. In at least one example embodiment, when the bottle 1598 is installed in the cradle 1516 for use, a vent cap 1598H can be removed from the vent port 1598G, and tubing and connectors can be connected to the fluid port 1598F (e.g., see FIGS. 19 and 20). FIG. 19J FIG. 26J

[0397] ​​​​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.

[0398] In at least one exemplary embodiment, as will be described below in the accompanying FIG. 15K 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.

[0399] 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., Exemplary communication method for a blood component separation system 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.

[0400] In contrast, in at least one example embodiment, when the bottle 1598 is in an incorrect orientation within the cradle 1516, the opposing surface engages one or both of the alignment surfaces 1589, thereby preventing the protrusion 1598B from being positioned in the alignment region 1591. In the incorrect orientation, fluid can be pushed from the bottle 1598 through the vent port 1598G, which can be below the level of the incorrect orientation. When the flow is reversed, air will be drawn from within the bottle 1598 instead of the intended fluid.

[0401] An example aspect is directed to a bottle tray 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 valley portions at least partially surrounding the first magnet recess, wherein the plurality of cam lobe valley portions interrupt a first contact surface of the body; a support stem comprising: a mandrel extending along a longitudinal axis from a first end of the mandrel to a second end of the mandrel; a cam body disposed at the second end of the mandrel; a second magnet recess disposed in the cam body; and a plurality of cam lobes extending from the cam body, the plurality of cam lobes arranged at least partially around the second magnet recess; wherein the support stem is movable between an engaged state with the interface plate and a disengaged state from the interface plate, wherein in the engaged state the plurality of cam lobes are disposed in contact with the plurality of cam lobe valley portions, wherein in the disengaged state the plurality of cam lobes are disposed out of contact with the plurality of cam lobe valley portions and in contact with the first contact surface of the body.

[0402] Any one or more of the above aspects further include a first magnet disposed in the first magnet recess, the first magnet including a first magnetic pole having a first polarity, the first magnet facing away from the body of the interface plate, and a second magnet disposed in the second magnet recess, the second magnet including a second magnetic pole having a second polarity, the second magnetic pole facing away from the cam body of the support post, wherein the first magnetic pole faces the second magnetic pole and the first polarity is opposite the second polarity. Any one or more of the above aspects include the support post being held in engagement with the interface plate by a magnetic force between the first magnet and the second magnet, the first movement of the support post relative to the interface plate causing the support post to separate a distance from the interface plate and move the support post from the engaged state to the disengaged state with the interface plate. Any one or more of the above aspects include the first movement including a rotational movement about the 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 cradle fixedly attached to the first end of the mandrel. Any one or more of the above aspects include the load deflection side moving independently of the support cradle. Any one or more of the above aspects include the plurality of cam lobe valleys including at least three cam lobe valleys arranged asymmetrically about an axis extending through a center of the first magnet recess, and the plurality of cam lobes including at least three cam lobes. Any one or more of the above aspects include the at least three cam lobes engaging the at least three cam lobe valleys in a single rotational direction about the axis through the center of the first magnet recess. Any one or more of the above aspects include the support post rotating about the longitudinal axis in the disengaged state without applying a rotational force to the load cell via the interface plate.

[0403] An example aspect is directed to a method of decoupling a support member from a load cell assembly, the method comprising: providing a load cell sensor assembly comprising: a support bracket; a load cell sensor comprising a fixed side and a load deflection side offset from the fixed side, wherein the fixed side of the load cell sensor is attached to the support bracket; an interface plate attached to the load deflection side of the load cell sensor, the interface plate comprising: a body; a first magnet recess disposed in the body; and a plurality of cam lobe valley portions at least partially surrounding the first magnet recess, wherein the plurality of cam lobe valley portions interrupts a first contact surface of the body; a support rod comprising: a mandrel extending a length along a longitudinal axis from a first end of the mandrel to a second end of the mandrel; a cam body disposed at the second end of the mandrel; a second magnet recess disposed in the cam body; and a plurality of cam lobes extending from the cam body, the plurality of cam lobes arranged at least partially around the second magnet recess; wherein the support rod is movable between an engaged state with the interface plate and a decoupled state from the interface plate, wherein in the engaged state the plurality of cam lobes are disposed in contact with the plurality of cam lobe valley portions, and in the decoupled state the plurality of cam lobes are disposed out of contact with the plurality of cam lobe valley portions and in contact with the first contact surface of the body; positioning the support rod in the engaged state with the interface plate such that the plurality of cam lobes are in contact with the plurality of cam lobe valley portions; receiving a movement force at the support rod, moving the support rod from the engaged state to the decoupled state, wherein the movement force comprises a rotational force about the longitudinal axis; and moving the support rod independently of the interface plate and without applying a specific rotational force to the interface plate and the load cell sensor when in the decoupled state.

[0404] FIG. 16B

[0405] In at least one example embodiment, the blood component separation system 200 as described herein can include one or more computer systems, such as the computer system 1627. The processor 1630 of the computer system 1627 can be configured to perform one or more processes and methods described herein. The processor 1630 can execute software. For example, the software can include firmware, applications, and / or an operating system that can manage the execution of the blood component separation system 200.

[0406] The software, including firmware, applications, operating systems, and other programmable features of the blood component separation system 200, can be updated from time to time to ensure that the blood component separation system 200 is functioning as desired.

[0407] The blood component separation system 200 can include an application that, among other functions, can perform fleet management and allow customers to install software for a large group of devices. The software system implemented by the blood component separation system 200 can be configured to generate and / or compile a device log (D-log) for transmission to a cloud storage location. The device log can be used for predictive analytics or other purposes. As FIG. 16A shown, each blood component separation system 200 can be in communication with a remote system server 1621 (e.g., over a communication network 1618, the cloud, etc.). During a startup process, each blood component separation system 200 can pass information about the software (including firmware version, error logs encountered, etc.) to the server 1621 using a method as FIG. 16A shown.

[0408] 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 example embodiment, the system server 1621 can automatically force a software and / or firmware update, or provide the user with the option to update the software and / or firmware. In at least one example 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 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 can be prevented from operating. This prevention 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 that allows operation.

[0409] FIG. 16D The method of FIG. 16 can begin at step 1600, where the blood component separation system 200 can be in an off or unused state. At step 1603, the blood component separation system 200 can be powered on and can undergo a startup process. As FIG. 16B shown, the computer system 1627 can be configured to detect the startup of the blood component separation system 200, or the computer system 1627 can be configured to automatically perform the process as described herein upon startup.

[0410] In response to detecting the startup, the computer system 1627 can transmit data to the server 1621 via a connection to the network 1618, as FIG. 16A shown. The data transmitted to the server 1621 can include one or more of the following: a data log, a firmware version identifier, and an error log.

[0411] At step 1609, in response to the data sent to the server 1621, the blood component separation system 200 can receive a response from the server 1621. The server 1621 can be configured to determine, based on the data, whether the software of the blood component separation system 200 is current and / or up-to-date. If the software is outdated or not a current version, the server 1621 can send a lock signal or other type of data packet indicating that the blood component separation system 200 requires a software update prior to use. In at least one example embodiment, the blood component separation system 200 can be inoperable until receiving a positive confirmation from the server 1621 via the network connection 1618 that the software is up-to-date. In this way, risks associated with using an outdated blood component separation system 200 can be avoided. For example, at step 1612, use of the blood component separation system 200 can be prevented based on the response received from the server.

[0412] In at least one example embodiment, if the server 1621 determines that the software is outdated, the server can 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 can be automatically updated. For example, the software update can be automatically initiated after receiving the one or more files for updating the software from the server. In at least one example embodiment, upon receiving the one or more files for updating the software, the blood component separation system 200 can enable the user to manually update the system. For example, the user can manually initiate the software update after receiving the one or more files. Once the software has been updated, the blood component separation system 200 can be configured to unlock and allow use of the system.

[0413] In at least one example embodiment, FIG. 16C The method shown in FIG. 16 can further include, after preventing use of the blood component separation machine, determining whether the unlock requirement has been satisfied. For example, the unlock requirement can include properly updating the software. In response to determining that the unlock requirement has been satisfied, the blood component separation system 200 can enable the use function.

[0414] In at least one example embodiment, the message can be displayed on a graphical user interface 1624 of the blood component separation system 200, as shown in FIG. 17. Exemplary methods and processes for providing feedback of a donation process The message can inform the user whether the blood component separation system 200 is locked due to outdated software and can enable the user to manually install updated software as needed. In at least one example embodiment, the user can manually initiate installation of the software update using the graphical user interface (GUI) 1624. In other embodiments, the user can connect an external device including the updated software to the blood component separation system 200 to initiate and install the software update.

[0415] At least one example embodiment includes a method comprising: detecting an initiation of a blood component separation machine; in response to detecting the initiation, transmitting data to a server; in response to the data, receiving a response from the server; and based on the response from the server, preventing use of the blood component separation machine.

[0416] Aspects of the above embodiments include the data transmitted to the server comprising one or more of: a data log, a firmware version identifier, and an error log. Aspects of the above embodiments include the response comprising a lock signal. Aspects of the above embodiments include the response comprising a firmware update. Aspects of the above embodiments include automatically installing the firmware update. Aspects of the above embodiments include the blood component separation machine being unblocked for use after installing the firmware update. Aspects of the above embodiments include the firmware update being manually installed by a user. Aspects of the above embodiments include displaying a message on a graphical user interface based on the response from the server. Aspects of the above embodiments include the graphical user interface enabling a user to initiate a firmware installation. Aspects of the above embodiments include, after preventing use of the blood component separation machine, determining that an unlock requirement has been satisfied; and in response to determining that the unlock requirement has been satisfied, enabling use of the blood component separation machine. Aspects of the above embodiments include the unlock requirement being associated with the updated firmware.

[0417] ​

[0418] The blood component separation system 200 can include one or more interface elements (e.g., display devices, light emitting diodes (LEDs), alarms, etc.) that provide information to the user and / or the donor 102 regarding the donation process. In one example, these interfaces can indicate to the donor 102 that the donor 102 should squeeze (e.g., when the pressure or flow drops below a predetermined threshold, etc.). Additionally or alternatively, the interface elements can indicate to the donor 102 their progress through the donation process. In any case, this feedback can be provided by the blood component separation system 200 in audible and / or visual output (e.g., via one or more speakers, display devices, LEDs, etc.). In at least one example embodiment, the LEDs can be arranged on a side of the blood component separation system 200 that provides this feedback to the donor 102.

[0419] FIG. 17A The method shown in the flowchart of FIG. 17 can begin at step 1700. At the beginning of the method, a blood component separation system (such as the blood component separation system 200) can be powered on and connected to a donor (such as the donor 102).

[0420] At step 1703, the computer system of the blood component separation system 200 can detect the start of the donation process. In at least one example embodiment, the detection itself can not be required, but can be performed automatically as part of the donation process FIG. 17A The method shown in FIG. 17. For example, detecting the start of the donation process can include initiating the donation process. In at least one example embodiment, detecting the start of the donation process can include detecting the flow of fluid, for example, by using one or more sensors, such as the fluid sensor 316.

[0421] At step 1706, once the donation process has started, the blood component separation system can provide an output that the donor 102 can notice. For example, the output can be a light, a sound, a GUI display, etc. The output can be provided within the line of sight of the donor 102. In at least one example embodiment, a side of the blood component separation system 200 can include an output 1724, as shown in FIG. 17B For example, the output 1724 can include a series of lights, such as LEDs. While the output 1724 is shown on a particular side of the blood component separation system 200, it should be understood that the output 1724 can be on any side of the blood component separation system 200 and can be within the range of the donor 102 such that the output can be one or more that the donor 102 sees and hears.

[0422] In at least one example embodiment, the output 1724 can be a display device. For example, the output 1724 can illuminate or glow in order 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. The output 1724 can be configured to illuminate or glow in a pulsing manner, where the rate of the light pulses can be synchronized with the rate at which the donor should squeeze her hand to achieve an optimal flow rate.

[0423] At step 1709, the method can include determining that the donation process has completed and / or the percentage remaining. For example, this step can include determining the amount of time remaining in the donation process. Determining the amount of time remaining can include first determining the amount of plasma that the donor 102 is expected to donate. Determining the amount of plasma that the donor is expected to donate can include receiving donor information as part of initiating the process. For example, the donor information can be received from the donor's identification card via a reader, such as the reader 1221 described above, or a scanner.

[0424] Determining the amount of time remaining can include dividing the amount of plasma expected to be donated by the donor by the expected flow rate. For example, if the blood component separation system 200 determines that there is 1 liter of plasma expected to be donated that has not yet been donated, and that the plasma is expected to be donated at a rate of 1 liter per minute, the blood component separation system 200 can determine that there is 1 minute remaining in the donation process.

[0425] At step 1712, the method can include updating the output in response to detecting the amount of time remaining in the donation process.

[0426] In at least one example embodiment, updating the output, such as output 1724, can include adjusting the number of lights or the illumination percentage of a display. For example, as shown in FIG. 17, the output 1724 can include five lights 1727a-1727e. Each of the five lights 1727a-1727e can be independently illuminated based on the amount of time remaining. Further, as described above, the lights 1727a-1727e can be pulsed, i.e., the brightness of each light can be independently adjusted, such that a pulsing effect can be achieved. FIGS. 17C-17E

[0427] As shown in FIG. 17, each light of the output 1724 can be turned off or otherwise not illuminated to indicate to the donor that the donation process has just begun. As shown in FIG. 17, one or more of the lights 1727a-1727e can be illuminated based on the amount of time remaining compared to the total time of the donation process. For example, if the donation process is sixty percent complete, sixty percent of the lights can be illuminated. As shown in FIG. 17, each light of the output 1724 can be illuminated to indicate to the donor that the donation process has been completed or is close to completion. In at least one example embodiment, the color of the lights 1727a-1727e of the output 1724 can change upon completion of the donation process. FIG. 17C FIG. 17D FIG. 17E

[0428] At step 1715, the method can include detecting a pressure loss. Detecting a pressure loss can include detecting a drop in pressure of the fluid in the blood component separation machine 200 below a predetermined threshold. The pressure loss can be due to poor circulation of the donor’s 102 blood, a collapsed vein, insufficient pump power, or other reasons. In some cases, the donor 102 can need to squeeze her hand to speed up the flow rate into the blood component separation system 200. By squeezing her hand at a particular rate, the donor 102 is able to control the flow rate into the blood component separation system 200.

[0429] ​​​​At step 1718, in response to detecting the pressure loss, the method can include updating the output 1724. For example, in response to detecting the pressure loss, the blood component separation system 200 can update the output 1724 such that the output 1724 indicates that the donor 102 squeeze. Updating the output 1724 to indicate that the donor squeeze can include flashing. For example, one or more of the lights 1727a-1727e can be turned on and off. In at least one example embodiment, the brightness of one or more of the lights 1727a-1727e can be pulsed at a particular rate. The rate of the light pulses or flashes can be based on a particular flow rate that needs to be reached to complete the donation process.

[0430] At step 1721, when the donation is complete, the method can end. In at least one example embodiment, ending the method can include detecting the end of the donation process. Ending the method can include turning off the output 1724. For example, after detecting the end of the donation process, the blood component separation system 200 can execute an output routine that indicates to the donor 102 that the donation process is complete. Such an output routine can include one or more of the following: flashing the lights of the output 1724 in a particular sequence, changing the color of the lights of the output 1724, generating a noise, or producing some other noticeable output that 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.

[0431] In at least one example embodiment, during the donation process, the blood component separation system 200 can be configured to detect an alarm event and, in response, alert the user. For example, during a plasma donation process, 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 factor is incorrect, too high, too low, etc., the processor can generate a graphical output that can alert the user of the alarm event and / or indicate to the user how to resolve the alarm event.

[0432] Detecting an alarm event associated with the blood component separation system can include monitoring factors such as temperature, pressure, flow rate, fluid color, weight of plasma received, data received from a scanner, motor control, centrifuge speed, software failure modes, and / or other factors related to the donation process.

[0433] Detecting an alarm event can 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.

[0434] Sensors can be disposed throughout the blood component separation system 200 and can be configured to monitor various aspects of the donation process, such as the weight of the plasma donation bottle, the flow rate and flow pressure of the tubing, the speed of the centrifuge, and / or other elements.

[0435] An alarm event can be detected when one of the factors exceeds a threshold or reaches a particular value. The threshold can be an upper threshold or a lower threshold, or can be a particular amount or a particular range. For example, in cases where the alarm relates to the color of the fluid, the threshold can be a particular color or a particular range of colors.

[0436] The threshold can also relate to time or a range of time. For example, an alarm event can be detected when data received from a scanner, such as donor identification data, is outdated or expired. In at least one example embodiment, an alarm event can be detected when data received from a scanner indicates one or more of an expired instrument or device, an invalid instrument or device, and an incompatible instrument or device.

[0437] In at least one example embodiment, an alarm event can be based on data from multiple sensors. For example, an alarm event can occur when both the pressure and the temperature exceed particular thresholds.

[0438] After detecting the alarm, the processor can generate or retrieve a graphical presentation output based on the detected alarm event.

[0439] Generating the graphical presentation output can include providing text describing the alarm event, providing one or more images describing the alarm event, and / or providing other content intended to indicate to the user how to resolve the alarm.

[0440] Retrieving the graphical presentation output can include extracting one or more texts describing the alarm event, one or more images describing the alarm event, and / or other content intended to indicate to the user how to resolve the alarm from memory.

[0441] The instructions include at least one instruction to move the blood component separation system 200 from the alarm state to an operational state. The instructions to move the blood component separation system 200 from the alarm state to an operational state can include visual aids and / or text informing the user of which steps can be performed to resolve the issue behind the alarm event. For example, the instructions can 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 example embodiment, the instructions can include instructing the user to end the donation process and disconnect the donor from the blood component separation system 200.

[0442] After generating and / or retrieving the graphical presentation output based on the detected alarm event, the processor can render the graphical presentation output to a graphical user interface of the blood component separation system.

[0443] In at least one example embodiment, the processor can additionally or alternatively render the graphical presentation output to a GUI, such as the GUI 1230 shown in FIG. 13B; illuminate one or more LEDs; and / or output an audible sound upon detection of an alert event. The LEDs can switch between a variety of colors, such as orange, yellow, red, and cyan. The color of the LEDs can be selected by the processor to correspond to the type of alert event detected. In at least one example embodiment, the LEDs can include one or more lights 2339, as will be discussed below with reference to FIG. 23B. FIG. 12B FIG. 22C

[0444] In at least one example embodiment, each color can be associated with a different type and / or level of alert. For example, the type of alert can indicate that the alert is associated with one or more of temperature, pressure, flow rate, color, and weight.

[0445] For example, the level of the alert can indicate the severity of the procedure of the alert or the priority of the alert. In at least one example 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 alert can be set for a pressure of 5 PSI or less, and a severe alert can be set for a pressure of zero PSI. In at least one example embodiment, a high severity alert can be red. In at least one example embodiment, a medium priority alert can be yellow or orange. In at least one example embodiment, a low priority alert can be green or blue. In at least one example embodiment, the light can be off or unlit if no alert event is currently detected.

[0446] In at least one example embodiment, the severity or priority of the alert can be indicated by the flashing or flickering of the light. The rate at which the light flashes can also indicate the severity of the alert. For example, a light that flashes at a faster speed or at a faster cadence can indicate a higher severity and priority, and a light that flashes at a slower speed or at a slower cadence can indicate a lower priority.

[0447] In at least one example embodiment, the sound alert or sound can indicate the severity or priority of the alert event. For example, various sounds, sound patterns, and sound frequencies can indicate priority. For example, a higher frequency sound can indicate a higher priority alert event, and a lower frequency sound can indicate a lower priority alert event. In at least one example embodiment, the rate at which the sound is emitted can indicate the severity of the alert event. For example, a sound that occurs more frequently over a period of time, such as a beeping sound, can indicate a higher priority alert event. ​​

[0448] The color of the alert can be set according to the alert type and severity. For example, a temperature related alert can be a blue light, and the brightness or shade of the color can be adjusted according to the alert severity.

[0449] In at least one example embodiment, the graphical presentation output can include a timestamp indicating a time of occurrence of the alert event.

[0450] In at least one example embodiment, the graphical presentation can include a description of the alert and a list of actions to resolve the alert.

[0451] In at least one example embodiment, the graphical presentation output can include an illustration associated with the alert event. For example, a photograph or illustration can be displayed to indicate to the user how to resolve the alert status.

[0452] In at least one example embodiment, the graphical presentation includes GUI elements that enable the user to perform one or more of resetting the donation process, continuing the donation process, and ending the donation process.

[0453] In at least one example embodiment, after rendering the graphical presentation output, the method can include performing a system check. In at least one example embodiment, the system check can be performed continuously during the donation process. Performing the system check can include polling data associated with the alert event to determine whether the factor that caused the alert event has returned to a normal level. If the factor that caused the alert event has returned to a normal level, the alert can be resolved and ended. In at least one example embodiment, the alert event can require ending the donation process and disconnecting the donor from the blood component separation system 200. In these embodiments, the system check can determine that the alert event can not be resolved or recoverable, and can trigger an alert and / or provide instructions to end the donation process and disconnect the donor 102.

[0454] For example, if a temperature drops below a predetermined threshold to cause the alert event, performing the system check can include determining whether the temperature is at the predetermined threshold or whether the temperature is above the predetermined threshold.

[0455] At least one example embodiment includes a method comprising: detecting a start of a donation process; providing an output in response to detecting the start of the donation process; determining an amount of time remaining for the donation process; updating the output in response to detecting the amount of time remaining for the donation process; detecting a pressure loss; updating the output in response to detecting the pressure loss; detecting an end of the donation process; and updating the output in response to detecting the end of the donation process.

[0456] Aspects of the above embodiments include that the donation process is a plasma donation using a blood component separation machine. Aspects of the above embodiments include that detecting the start of the donation process includes detecting a flow of fluid. Aspects of the above embodiments include that the output is one or more of light and sound. Aspects of the above embodiments include that the output is disposed on a side of the blood component separation machine. Aspects of the above embodiments include that the output is within range of the donor. Aspects of the above embodiments include that the output can be one or more of seen and heard by the donor. Aspects of the above embodiments include that the output is a display device. Aspects of the above embodiments include that the display device displays a series of lights. Aspects of the above embodiments include that the series of lights updates to show the donor an amount of time remaining in the donation process. Aspects of the above embodiments include that the series of lights pulses light to indicate to the donor to squeeze. Aspects of the above embodiments include that the pulse of light has a cadence associated with a rate at which the donor should squeeze to maintain pressure. Aspects of the above embodiments include that 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 embodiments include that in response to detecting the loss of pressure, updating the output includes indicating to the donor to squeeze. Aspects of the above embodiments include that in response to detecting an end of the donation process, updating the output includes stopping an audible noise or turning off the lights.

[0457] At least one example 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.

[0458] Aspects of the above method include that the method is performed by a blood component separation system for performing a plasma donation process. Aspects of the above method include that the alarm event is related to one or more of the following factors: temperature, pressure, flow rate, color of fluid, receiving excess plasma, and data received from a scanner. Aspects of the above method include that the alarm event is associated with expired data received from a scanner. Aspects of the above method include that the alarm event is detected when one of the above factors exceeds a threshold value. Aspects of the above method include that detecting the alarm event includes receiving data from one or more sensors. Aspects of the above method include that retrieving the graphical presentation output includes generating the graphical presentation output. Aspects of the above method include that the graphical presentation output includes instructions describing the alarm event. Aspects of the above method include that 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 that the instructions include instructions to indicate the user to perform one or more of the following: connect a tubing, close a latch, and remove a kink from a tubing. Aspects of the above method include that an LED is illuminated upon detecting the alarm event. Aspects of the above method include that the processor selects a color of the LED to correspond to a type of the detected alarm event; wherein the color is selected from the group consisting of orange, yellow, red, and cyan; and the type of the alarm is associated with one or more of the following: temperature, pressure, flow rate, color, and weight. Aspects of the above method include that after rendering the graphical presentation output, performing a system check. Aspects of the above method include that performing the system check includes polling data associated with the alarm event. Aspects of the above method include that the graphical presentation output includes a timestamp indicating a time of occurrence of the alarm event. Aspects of the above method include that the graphical presentation output includes an illustration associated with the alarm event. Aspects of the above method include that the illustration indicates to the user to resolve the alarm state. Aspects of the above method include that the graphical presentation includes a description of the alarm and a list of actions to resolve the alarm. Aspects of the above method include that the graphical presentation includes GUI elements that enable the user to perform one or more of the following: reset the donation process, continue the donation process, and end the donation process.

[0459] Exemplary modular serviceable sled and interconnects

[0460] 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.

[0461] 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.

[0462] In at least one exemplary embodiment, pumps 208, 212, 216 (e.g., FIG. 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.

[0463] In addition to this, these modular serviceable carriages can enable components to be quickly decoupled from the blood component separation system and serviced separately from the blood component separation system. In at least one example embodiment, once a modular...

Claims

1. A method comprising: starting one or more pumps of a blood component separation machine; detecting a flow rate of a fluid through the blood component separation machine; detecting that the flow rate of the fluid is below a predetermined threshold; and in response to detecting that the flow rate of the fluid is below the predetermined threshold, adjusting a rate of one or more pumps of the blood component separation machine.

2. The method of claim 1, wherein, The detecting that the flow rate of the fluid is below a predetermined threshold comprises detecting a collapsed vein.

3. The method of claim 1, wherein, The detecting that the flow rate of the fluid is below a predetermined threshold comprises detecting a color of the fluid using a sensor.

4. The method of claim 3, wherein, The sensor detects one or more of red, blue, or green.

5. The method of claim 1, wherein, The detecting that the flow rate of the fluid is below a predetermined threshold comprises detecting a flow rate of the fluid using a sensor.

6. The method of claim 1, wherein, The detecting that the flow rate of the fluid is below a predetermined threshold comprises detecting a pressure of the fluid flow using a sensor.

7. The method of claim 1, wherein, The detecting that the flow rate of the fluid is below a predetermined threshold comprises detecting a temperature of the fluid using a sensor.

8. The method of claim 1, wherein, The adjusting a rate of one or more pumps of the blood component separation machine comprises sending a control signal to the one or more pumps.

9. The method of claim 1, wherein, The adjusting a rate of one or more pumps of the blood component separation machine comprises changing a power applied to the one or more pumps.

10. The method of claim 1, wherein, The adjusting a rate of one or more pumps of the blood component separation machine comprises turning off the one or more pumps.

Images