Systems and methods for processing whole blood into red blood cell, plasma and platelet products

Abstract

To provide systems and methods for processing whole blood into red blood cell, plasma and platelet products.SOLUTION: A processing device includes a pump system, a valve system, a centrifuge, and a controller. A fluid flow circuit is mounted on the device to execute a procedure in which whole blood is processed into a red blood cell product, a plasma product, and a platelet concentrate product. The blood is first separated into red blood cells, a buffy coat and plasma using the centrifuge, with the red blood cells and plasma being removed from the centrifuge, while the buffy coat remains in the centrifuge. The fluid remaining in the centrifuge is circulated through the centrifuge to form a homogenous mixture. Once the mixture is formed, it is separated in the centrifuge into platelet concentrate and red blood cells. A platelet product is then collected by using whole blood or previously collected red blood cells to push the platelet concentrate from the centrifuge to a collection container.SELECTED DRAWING: None

Description

Technical Field

[0001] The present disclosure relates to the separation of whole blood. More specifically, the present disclosure relates to the separation of whole blood into red blood cells, plasma, and platelet products.

Background Art

[0002] It is well known to collect whole blood from donors using manual collection procedures, such as through blood donations or visits by donors to blood centers or hospitals. In such procedures, the blood is typically collected by simply flowing it from the donor into a collection container (e.g., a flexible pouch or bag) under the influence of gravity and venous pressure. Various blood collection devices may be used to assist or facilitate the collection of blood or blood components.

[0003] The collection container in manual collection is often part of a larger pre-assembled arrangement of tubes and containers (sometimes called satellite containers) that are used when further processing the collected whole blood. More specifically, whole blood is typically first collected into a so-called primary collection container that also contains an anticoagulant, such as, but not limited to, a solution of sodium citrate, phosphate, and dextrose ("CPD").

[0004] After the initial collection, it is common practice to transport the collected whole blood to another facility or location, sometimes called a "back lab," for further processing to separate red blood cells, platelets, and plasma. This may involve performing additional steps such as cell washing and the preparation and collection of plasma cryoprecipitate. This process typically requires manually loading the primary collection container and associated tubing and satellite containers into a centrifuge to separate the whole blood into concentrated red blood cells and platelet-rich or platelet-poor plasma. The separated components are squeezed from the primary collection container into one or more satellite containers, and the red blood cells are combined with pre-filled additives or preservatives in one of the satellite containers. After the above steps, the blood components can be centrifuged again as needed, for example, to separate platelets from plasma. The entire process requires multiple large floor centrifuges and liquid presses. Because it involves the interaction of multiple operators, this process is labor-intensive, time-consuming, and prone to human error.

[0005] Therefore, efforts continue to automate the devices and systems used for post-collection processing of whole blood, and recently, the use of automated blood component separators for such post-collection processing has been proposed. The subject matter disclosed herein provides further advances in various embodiments of devices, systems, and methods that can be used in post-collection processing systems (also applicable to the processing of blood collected from living donors) by using continuous flow centrifugation to separate a unit of whole blood into red blood cells, plasma, and platelet products.

[0006] Unlike conventional methods (collecting multiple buffy coats, pooling them, and then separating them to produce platelet products), current methods and systems resuspend platelets from a single buffy coat in plasma and collect the platelet products. The platelet products can be easily pooled together with similarly obtained platelet products without the need for subsequent processing or potential platelet loss, as in the case of conventional buffy coat collection and pooling. The absence of subsequent processing (and potential platelet loss) may allow obtaining the desired amount of platelet products using fewer units of blood than required by conventional approaches. [Overview of the Initiative]

[0007] There are several embodiments of the subject matter that can be embodied separately or together in the apparatus and systems described and claimed below. These embodiments may be used alone or in combination with other embodiments of the subject matter described herein, and the description of these embodiments together is not intended to preclude the use of these embodiments separately or the claim of such embodiments separately or in different combinations within the claims attached herein.

[0008] In one embodiment, the blood processing system includes a reusable processing unit and a disposable fluid flow circuit. The processing unit includes a pump system, a valve system, a centrifuge, and a control unit, and the disposable fluid flow circuit includes a processing chamber that receives the blood from the centrifuge, an erythrocyte collection container, a platelet concentrate collection container, and a number of conduits that fluidly connect the components of the fluid flow circuit. The control unit is configured to instruct the pump system and the valve system to cooperate in transporting whole blood from the blood source to the processing chamber. The control unit is also configured to perform a separation establishment step in which the centrifuge operates to separate the whole blood in the processing chamber into plasma and erythrocytes, the pump system and the valve system cooperate in transporting the separated plasma and erythrocytes out of the processing chamber, recombining the separated plasma and erythrocytes as recombined whole blood, and transporting the recombined whole blood to the processing chamber. The control unit is further configured to perform a collection step, in which the pump system transports whole blood from the blood source to the processing chamber. The centrifuge separates the whole blood in the processing chamber into plasma, buffy coat, and erythrocytes. The pump system and valve system work together to transport at least a portion of the separated plasma out of the processing chamber and at least a portion of the separated red blood cells from the processing chamber to the red blood cell collection container, while the fluid containing the buffy coat remains in the processing chamber. The control unit then performs a platelet resuspension step, comprising a first step in which the centrifuge is deactivated and the pump system and valve system work together to circulate the fluid in the processing chamber through a fluid flow circuit to form a homogeneous mixture, and a second step in which the centrifuge is activated to separate the homogeneous mixture into concentrated platelets and red blood cells. The control unit then performs a platelet collection step in which the pump system and valve system work together to transport at least a portion of the whole blood from the blood source or the contents of the red blood cell collection container to the processing chamber and at least a portion of the concentrated platelets from the processing chamber to the concentrated platelet collection container.

[0009] In another embodiment, a method is provided for processing whole blood into erythrocyte products, plasma products, and platelet products. This method includes transporting whole blood from a blood source to a processing chamber of a fluid flow circuit. Next, a separation establishment step is performed in which a centrifuge is operated to separate the whole blood in the processing chamber into plasma and erythrocytes, the separated plasma and erythrocytes are transported out of the processing chamber and recombined as recombined whole blood, and the recombined whole blood is transported back into the processing chamber. Following the separation establishment step, a collection step is performed. In the collection step, whole blood is transported from the blood source to the processing chamber, a centrifuge is operated to separate the whole blood in the processing chamber into plasma, buffy coat, and erythrocytes. At least a portion of the separated plasma is transported out of the processing chamber, and at least a portion of the separated erythrocytes is transported out of the processing chamber and transported together with the fluid containing the buffy coat remaining in the processing chamber during the collection step to an erythrocyte collection container of a fluid flow circuit. Next, a platelet resuspension step is performed, which includes a first step in which the centrifuge is stopped and the fluid in the processing chamber is recirculated through a fluid flow circuit to form a homogeneous mixture, and a second step in which the centrifuge is activated to separate the homogeneous mixture into concentrated platelets and red blood cells. Finally, a platelet collection step is performed, in which at least a portion of the contents of the whole blood or red blood cell collection container from the blood source is transported into the processing chamber and at least a portion of the platelet concentrate is transported from the processing chamber to the platelet concentrate collection container in the fluid flow circuit.

[0010] In yet another aspect, the blood processing device includes a pump system, a valve system, a centrifuge, and a control unit. The control unit is configured to instruct the pump system and the valve system to cooperate in transporting whole blood from a blood source to a centrifuge. The control unit is also configured to perform a separation establishment step in which the centrifuge operates to separate the whole blood in the centrifuge into plasma and red blood cells, the pump system and the valve system cooperate in transporting the separated plasma and red blood cells out of the centrifuge, recombining the separated plasma and red blood cells as recombined whole blood, and transporting the recombined whole blood back to the centrifuge. The control unit is further configured to perform a collection step in which the pump system transports whole blood from a blood source to the centrifuge, the centrifuge separates the whole blood in the centrifuge into plasma, buffy coat, and red blood cells, and the pump system and the valve system cooperate in transporting at least a portion of the separated plasma out of the centrifuge and at least a portion of the separated red blood cells out of the centrifuge for collection, along with the fluid containing the buffy coat remaining in the centrifuge. Next, the control unit performs a platelet resuspension step, comprising a first step in which the centrifuge is stopped and the pump system and valve system work together to circulate the fluid in the centrifuge through the centrifuge to form a homogeneous mixture, and a second step in which the centrifuge operates to separate the homogeneous mixture into platelet concentrate and red blood cells. Subsequently, the control unit performs a platelet harvesting step in which the pump system and valve system work together to transport at least a portion of whole blood from a blood source or collected red blood cells to the centrifuge and at least a portion of the platelet concentrate out of the centrifuge for collection. [Brief explanation of the drawing]

[0011] [Figure 1] This is a perspective view of an exemplary reusable hardware component of a blood processing system configured to accept a disposable fluid flow circuit.

[0012] [Figure 2] Figure 1 is a plan view of an exemplary disposable fluid flow circuit for use in combination with the durable hardware components.

[0013] [Figure 3] Figure 2 is a schematic diagram of a fluid flow circuit attached to the processing apparatus in Figure 1 in order to complete a blood processing system according to one aspect of this disclosure.

[0014] [Figure 4] Figure 3 is a schematic diagram of a blood processing system performing the "blood priming" stage of an exemplary blood processing procedure.

[0015] [Figure 5] Figure 3 is a schematic diagram of a blood processing system performing the "separation and establishment" and "platelet resuspension" stages of an exemplary blood processing procedure.

[0016] [Figure 6] Figure 3 is a schematic diagram of a blood processing system performing the "collection" stage of an exemplary blood processing procedure, where the separated red blood cells have been reduced in white blood cells before collection.

[0017] [Figure 7] This is a schematic diagram of a variation of the "collection" stage in Figure 6, where the separated red blood cells have not been reduced in white blood cells before collection.

[0018] [Figure 8] Figure 3 is a schematic diagram of a blood processing system performing the "platelet collection" stage of an exemplary blood processing procedure, in which platelets are collected using whole blood, and the separated red blood cells are reduced in white blood cells before collection.

[0019] [Figure 9] This is a schematic diagram of a variation of the "platelet collection" stage in Figure 8, where the separated red blood cells have not been reduced in white blood cells before collection.

[0020] [Figure 10] This is a schematic diagram of a variation of the "platelet collection" stage in Figure 8, where platelets are collected using the collected red blood cells and whole blood pump.

[0021] [Figure 11] It is a variation of the "platelet collection" stage in FIG. 10 where the whole blood pump is not operating.

[0022] [Figure 12] It is a schematic diagram of the blood treatment system of FIG. 3 that executes the "red blood cell collection" stage of an exemplary blood treatment procedure, in which the collected red blood cells are leukocyte-reduced before collection.

[0023] [Figure 13] It is a schematic diagram of a variation of the "red blood cell collection" stage in FIG. 12, in which the separated red blood cells are not leukocyte-reduced before collection.

[0024] [Figure 14] It is a schematic diagram of the blood treatment system of FIG. 3 that executes the "additive solution flush" stage of an exemplary blood treatment procedure, and the additive solution is guided through a leukocyte reduction filter before entering the red blood cell collection container.

[0025] [Figure 15] It is a schematic diagram of a variation of the "additive solution flush" stage in FIG. 14, in which the additive solution enters the red blood cell collection container without passing through the leukocyte reduction filter.

[0026] [Figure 16] It is a schematic diagram of the blood treatment system of FIG. 3 that executes the "air discharge" stage of an exemplary blood treatment procedure.

[0027] [Figure 17] It is a schematic diagram of the blood treatment system of FIG. 3 that executes the "sealing" stage of an exemplary blood treatment procedure.

Embodiments for Carrying Out the Invention

[0028] The embodiments disclosed herein are intended to provide a description of the subject matter, and it should be understood that the subject matter can be embodied in various other forms and combinations not shown in detail. Accordingly, specific designs and features disclosed herein should not be construed as limiting the subject matter as defined in the appended claims.

[0029] Figure 1 shows a reusable hardware component or processing unit of a blood processing system, generally denoted by reference numeral 10, while Figure 2 shows a disposable fluid flow circuit, generally denoted by reference numeral 12, used in conjunction with the processing unit 10 for processing collected whole blood. The illustrated processing unit 10 includes associated pumps, valves, sensors, displays, and other devices for configuring and controlling the fluid flow through the fluid flow circuit 12, which are described in more detail below. The blood processing system may be directed by a control unit integrated with the processing unit 10, which includes a programmable microprocessor for automatically controlling the operation of pumps, valves, sensors, etc. The processing unit 10 may also include wireless communication capabilities that enable the transfer of data from the processing unit 10 to an operator's quality control system.

[0030] More specifically, the illustrated processing unit 10 includes a user input and output touchscreen 14, a pump station including a first pump 16 (e.g., for pumping whole blood), a second pump 18 (e.g., for pumping plasma), and a third pump 20 (e.g., for pumping additive solutions), a centrifuge-mounted station and drive unit 22 (sometimes referred to herein as the “centrifuge”), and clamps 24a–c. The touchscreen 14 allows the user to interact with the processing unit 10, as well as monitor procedural parameters such as flow rate, container weight, and pressure. The pumps 16, 18, and 20 (collectively referred herein as part of the “pump system” of the processing unit 10) are illustrated as peristaltic pumps that accept tubing or conduits and can move fluid through the associated conduits at various speeds depending on the procedure being performed. An exemplary centrifuge-mounted station / drive unit is found in U.S. Patent No. 8,075,468 (see Figures 26–28), which is incorporated herein by reference. The clamps 24a-c (collectively referred to herein as part of the “valve system” of the processing apparatus 10) can open and close fluid paths through tubes or conduits, and may incorporate an RF sealer to complete the heat sealing of the tubes or conduits positioned in the clamps in order to seal the tubes or conduits leading to the product container at the end of the procedure.

[0031] Aseptic connection / docking devices can also be incorporated into one or more of the clamps 24a-c. Aseptic connection devices can use any of several different operating principles. Known aseptic connection devices and systems include, for example, radiant energy systems that melt the facing membrane of a fluid flow conduit, as in U.S. Patent No. 4,157,723; heated wafer systems that use a wafer to cut and thermally bond or splice tube segments together while the ends remain molten or semi-molten, as in U.S. Patents No. 4,753,697, 5,158,630, and 5,156,701; and systems that use a removable closure film or web sealed to the ends of tube segments, as described in, for example, U.S. Patent No. 10,307,582. Alternatively, sterile connections may be formed by compressing or pinching sealed tube segments, heating and cutting sealed ends, and joining the tube to similarly processed tube segments, as described in, for example, U.S. Patents 10,040,247 and 9,440,396. All of the above patents are incorporated in their entirety by reference. Other sterile connection devices based on other operating principles may also be used without departing from the scope of this disclosure.

[0032] The processing apparatus 10 also includes hangers 26a-d (each potentially associated with a weighing scale) for suspending various containers of disposable fluid circuits 12. The hangers 26a-d are preferably mounted on a vertically movable support 28 to improve the portability of the processing apparatus 10. An optical system including a laser 30 and a photodetector 32 is associated with the centrifuge 22 to determine and control the position of interfaces between separated blood components within the centrifuge 22. An exemplary optical system is shown in U.S. Patent Application Publication No. 2019 / 0201916, incorporated herein by reference. An optical sensor 34 is also provided for optically monitoring one or more conduits entering and leaving the centrifuge 22.

[0033] One side of the processing unit 10 includes a nesting module 36 for seating a flow control cassette 50 (Figure 2) of the fluid flow circuit 12 (described in more detail below). The cassette nesting module 36 is configured to accept various disposable cassette designs so that the system can be used to perform various types of procedures. Embedded within the illustrated cassette nesting module 36 are four valves 38a-d (collectively referred to herein as part of the “valve system” of the processing unit 10) for opening and closing the fluid flow path in the flow control cassette 50, and three pressure sensors 40a-c that can measure pressure at various locations in the fluid flow circuit 12.

[0034] Referring to Figure 2, the illustrated fluid flow circuit 12 includes a flow control cassette 50 and a processing / separation chamber 52 configured to house a centrifuge 22, along with several containers 42, 44, 46, 48, and 64. These are all interconnected by conduit or piping segments to enable continuous flow centrifugation. The flow control cassette 50 routes the fluid flow through three tubular loops 54, 56, and 58, each loop positioned to engage with a specific one of the pumps 16, 18, and 20. Conduits or tubes may extend through the cassette 50, or the cassette 50 may have pre-formed fluid channels that guide the fluid flow.

[0035] In the fluid flow circuit 12 shown in Figure 2, container 42 may be pre-filled with an additive solution, container 44 may be filled with whole blood and connected to the fluid flow circuit 12 when in use, container 46, container 48 may be an empty container for receiving red blood cells separated from whole blood, container 48 may be an empty container for receiving plasma separated from whole blood, and container 64 may be an empty container for receiving platelet concentrate separated from whole blood. Figure 2 shows a whole blood container 44 (e.g., configured as a blood pack unit) as a blood source, but the blood source being a living donor is within the scope of this disclosure as detailed herein. The fluid flow circuit may optionally include an air trap 60 (Figure 3) through which whole blood flows before it enters the separation chamber and / or a leukocyte reduction filter 62 through which red blood cells flow before they enter the red blood cell collection container 46.

[0036] The processing chamber 52 may be preformed to a desired shape and configuration by injection molding from a rigid plastic material, as shown and described in U.S. Patent No. 6,849,039, which is incorporated herein by reference. The specific shape of the processing chamber 52 may vary depending on the elements being separated, and this disclosure is not limited to the use of a particular chamber design. For example, it is within the scope of this disclosure that the processing chamber 52 be configured to be formed from a material that is flexible rather than a material that is rigid overall. When the processing chamber 52 is formed from a material that is flexible overall, the shape of the processing chamber 52 is determined by the centrifuge 22. An exemplary processing chamber and associated centrifuge formed from a flexible material is described in U.S. Patent No. 6,899,666, which is incorporated herein by reference.

[0037] In accordance with this disclosure, the control unit of the processing apparatus 10 is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by the operator via input to the touchscreen 14, and is configured to be further programmed by the operator to perform additional blood processing procedures. The control unit can be pre-programmed to substantially automate a wide variety of procedures, including but not limited to the generation of red blood cells and plasma from a single unit of whole blood (as described in PCT application number PCT / US21 / 22750), buffy coat pooling and separation into platelet products (as described in U.S. Patent Application Publication 2018 / 0078582 incorporated herein by reference), and platelet collection (as described in more detail herein). The control unit can also perform post-processing steps.

[0038] A pre-programmed blood processing procedure operates the system with pre-set settings for flow rate and centrifugal force, and a programmable control unit may be configured to receive input from the operator regarding one or more of the flow rate and centrifugal force for a standard blood processing procedure in order to override the pre-programmed settings.

[0039] Furthermore, the programmable control unit is configured to receive input from the operator via the touchscreen 14 in order to operate the system and perform non-standard blood processing procedures. More specifically, the programmable control unit may be configured to receive input for setting non-standard blood processing procedures, including flow rate and centrifugal force.

[0040] In the exemplary procedure, the processing apparatus 10 and the fluid flow circuit 12 can be used in combination to process whole blood into erythrocyte products, plasma products, and platelet products. The amount of whole blood to be processed varies, and in one embodiment, a single unit of blood is processed. Figure 3 is a schematic diagram of the fluid flow circuit 12 attached to the processing apparatus 10, showing selected components of the fluid flow circuit 12 and selected components of the processing apparatus 10. Figures 4-17 show different stages of the exemplary procedure.

[0041] In this specification, referred to as the “blood priming” stage, in the initial stage shown in Figure 4, selected components of the fluid flow circuit 12 are primed using blood from a blood source. This is in contrast to typical apheresis devices that prime the fluid flow circuit using a separately provided fluid (e.g., anticoagulant or saline), although priming the fluid flow circuit 12 using a more common priming fluid is also within the scope of this disclosure. The blood source is shown in Figure 4 as a whole blood container 44, but may instead be a living donor. Thus, it should be understood that the term “whole blood” may refer to blood containing anticoagulant or blood without anticoagulant.

[0042] During the blood priming phase, whole blood is drawn into the fluid flow circuit from the blood source (whole blood container 44 in the embodiment of Figure 4) via line L1 by the operation of a first pump 16 (which may be called the “whole blood pump”). A valve 38c is closed, and the blood is guided through the pressure sensor 40c to line L2. The blood passes through the air trap 60, the pressure sensor 40a (which measures the pressure in the processing chamber 52), and the optical sensor 34 before flowing into the processing chamber 52 located in the centrifuge 22 of the processing device 10.

[0043] The centrifuge 22 may remain stationary during the blood priming phase, or it may be controlled by the control unit of the processing device 10 to rotate at a low rotational speed (e.g., about 1,000 to 2,000 rpm). It may be advantageous for the centrifuge 22 to rotate during the blood priming phase to generate sufficient g-force to ensure that the air in the processing chamber 52 (including air already present in the processing chamber 52, along with air moved into the processing chamber 52 from lines L1 and / or line L2 by the blood flow) is pushed towards the low g (radially inward) wall of the processing chamber 52. Higher centrifuge rotational speeds, such as 4,500 rpm (which is necessary for steady-state separation, as described later), may be undesirable because air block (where air accumulates and cannot be pushed out of the processing chamber 52, causing a pressure increase) is more likely to occur at higher g-forces.

[0044] Blood entering the processing chamber 52 moves towards the high-g (radially outward) wall of the processing chamber 52, and air moves towards the low-g wall. The plasma outlet port of the processing chamber 52 is associated with the low-g wall of the processing chamber 52, and most of the air exits the processing chamber 52 through the plasma outlet port and associated line L3, but some air also exits the processing chamber 52 through the red blood cell outlet port associated with the high-g wall of the processing chamber 52.

[0045] Valves 38b and 38d are closed, while the second pump 18 (sometimes called the "plasma pump") is operating and the third pump 20 (sometimes called the "additive pump") is deactivated. This causes the air exiting the processing chamber 52 through the red blood cell outlet port to flow through the associated line L4 and pressure sensor 40b, into line L5, and then into line L14. Valve 38a is open, but clamp 24b is closed, so the air flowing through line L14 flows and then merges with the air flowing through line L3 (i.e., the air exiting the processing chamber 52 through the plasma outlet port). The combined air flows through line L7, opening clamp 24c, and enters the plasma collection container 48.

[0046] In Figures 4-17, the arrows on the containers should be understood to represent the direction of fluid flow between the container and the conduit connected to it. For example, line L7 is shown connected to the top of the plasma collection container 48, and the downward arrow (as in Figure 4) represents the downward fluid flow into the plasma collection container 48. In contrast, line L1 is shown connected to the bottom of the whole blood container 44, and the downward arrow (as in Figure 4) represents the downward fluid flow out of the whole blood container 44.

[0047] The airflow exiting the processing chamber 52 through one of the outlet ports is monitored by an optical sensor 34, which determines the optical density of the fluid flowing through the monitored line and can distinguish between air and non-air fluid in lines L3 and L4. When non-air fluid is detected in both lines L3 and L4, the control unit of the processing device 10 terminates the blood priming phase and moves to the next stage of the procedure. The amount of blood drawn from the blood source into the fluid flow circuit 12 during the blood priming phase varies depending on many factors (e.g., the amount of air in the fluid flow circuit 12), but can be around 50-100 mL. The blood swell phase may take 1-2 minutes.

[0048] The next stage (shown in Figure 5) is referred to herein as the “separation establishment” stage. When non-air fluid is detected in lines L3 and L4, the rotation speed of the centrifuge 22 is increased to a speed sufficient to separate the blood into concentrated red blood cells and platelet-poor plasma (e.g., approximately 4,500–5,500 rpm). To produce platelet-poor plasma products, it may be advantageous for the processing chamber 52 to be configured with a plasma outlet port located downstream of the blood inlet port at a distance from it, rather than being located adjacent to the blood inlet port. Such a configuration allows platelets to settle into a separate layer between the plasma and red blood cells (commonly called the “buffy coat”) before the plasma is removed from the processing chamber 52, thus making it possible to deplete the platelets from the separated plasma. With respect to the whole blood pump 16, it continues to operate, but no additional blood is drawn from the blood source into the fluid flow circuit 12 during the separation establishment stage (as described later).

[0049] In embodiments where the blood source includes only a single unit of whole blood (approximately 500 mL) (in the case of a whole blood container) or provides it (in the case of a living donor), the system must operate with a finite fluid volume. To avoid product loss or quality issues, the plasma and red blood cells, which are initially separated from the blood in the processing chamber 52 and then removed from the processing chamber 52, are not directed to their respective collection containers, but instead are mixed together to form recombined whole blood and recirculated back into the processing chamber 52.

[0050] More specifically, during the separation establishment phase, the separated plasma exits the processing chamber 52 via the plasma outlet port and associated line L3. During this phase, clamps 24b and 24c are closed, but valve 38a remains open, directing the plasma from line L3 to line L14. The separated red blood cells exit the processing chamber 52 via the red blood cell outlet port and associated line L4, while the buffy coat remains inside the processing chamber 52. In the illustrated embodiment, there is no pump associated with line L4 so that the red blood cells exit the processing chamber 52 at a rate equal to the difference between the rate of the whole blood pump 16 and the rate of the plasma pump 18. In alternative embodiments, there may be a pump associated with the red blood cell outlet line instead of the plasma outlet line, or a first pump associated with the plasma outlet line and a second pump associated with the red blood cell outlet line.

[0051] The additive pump 20 is not operating during this stage, so it sends red blood cells from line L4 to line L5. The plasma flowing through line L14 mixes with the red blood cells flowing through line L5 at the junction of the two lines L5 and line L14 to form recombined whole blood. Valve 38d is closed, and the recombined whole blood is directed to line L8. Valve 38b is also closed, and the recombined whole blood is directed from line L8 to line L9, passing through the open valve 38c. The whole blood pump 16 draws the recombined whole blood from line L9 to line L2 (rather than drawing additional blood from the blood source to the fluid flow circuit 12), and the recombined blood passes through the air trap 60, pressure sensor 40a, and optical sensor 34 before returning to the processing chamber 52, where it is again separated into plasma, buffy coat, and red blood cells.

[0052] The separation establishment phase continues until steady-state separation is achieved, which may take approximately 1 to 2 minutes. As used herein, the term “steady-state separation” refers to a state in which blood is separated into its components within the processing chamber 52 and the radial position of the interface between the separated components within the processing chamber 52 is maintained at least substantially (rather than moving radially inward or outward). The interface position may be determined and controlled according to any suitable approach, including the use of an interface detector of the type described in U.S. Patent Application Publication No. 2019 / 0201916.

[0053] Preferably, steady-state separation is achieved when the interface between the separated components in the processing chamber 52 is at a target position. The target position corresponds to the position of the interface where the separation efficiency is optimized, and the exact position varies depending on many factors (e.g., whole blood hematocrit). However, in exemplary embodiments, the target position of the interface may be the position of the interface when approximately 52% of the thickness or width (radially) of the channel defined by the processing chamber 52 is occupied by red blood cells. In the illustrated embodiment, the position of the interface in the processing chamber 52 can be adjusted by changing the flow rate of the plasma pump 18, increasing the flow rate to draw more separated plasma from the processing chamber 52 (thus reducing the thickness of the plasma layer in the processing chamber 52) and moving the interface toward a low g wall, or drawing less plasma from the processing chamber 52 (thus increasing the thickness of the plasma layer in the processing chamber 52) and moving the interface toward a high g wall.

[0054] In an exemplary procedure, the control unit of the processing apparatus 10 controls the whole blood pump 16 to operate at a constant speed, and the plasma pump 18 initially operates at the same speed, rapidly increasing the thickness of the red blood cell layer in the processing chamber 52 and moving the interface toward the low g wall. The speed of the plasma pump 18 is gradually decreased as the thickness of the red blood cell layer increases and the position of the interface approaches the target position. As described above, this means that the target position of the interface depends on the hematocrit of the whole blood, and the speed of the plasma pump 18 (which controls the position of the interface) may also depend on the hematocrit of the whole blood. In one embodiment, this relationship can be expressed as follows:

[0055] Theoretical plasma pump velocity = whole blood pump velocity - ((whole blood hematocrit × whole blood pump velocity) / hematocrit of separated red blood cells) [Equation 1]

[0056] The hematocrit of whole blood may be measured by the optical sensor 34 before or during the procedure, and the hematocrit of separated red blood cells may be determined during the procedure by the optical sensor 34 monitoring line L4. In practice, the plasma pump velocity does not usually remain at the theoretical velocity once steady-state separation is achieved at the interface of the target position, but instead tends to "flutter" around the theoretical velocity.

[0057] The control unit of the processing unit 10 performs the separation establishment phase, and once steady-state separation is established, regardless of the specific method by which steady-state separation is achieved, the control unit terminates the separation establishment phase and proceeds to the “collection” phase shown in Figure 6 below. At the start of the collection phase, the centrifuge 22, whole blood pump 16, and plasma pump 18 all continue to operate at the same speed they were operating at the end of the separation establishment phase. However, the valve system of the processing unit 10 is adjusted to direct the separated plasma and red blood cells to their respective collection containers (rather than recombining them and recirculating them through the centrifuge 22), while additional blood is drawn from the blood supply into the fluid flow circuit 12 until a total of one unit or other target volume of whole blood is drawn into the fluid flow circuit 12.

[0058] More specifically, during the collection phase, valve 38c is closed, which causes the whole blood pump 16 to draw additional blood from the blood source (which is the whole blood container 44 in the illustrated embodiment, but could be a living donor) into line L1. The whole blood pump 16 draws the blood from the blood source from line L1 to line L2, and the blood passes through the air trap 60, pressure sensor 40a, and optical sensor 34 before flowing into the processing chamber 52, where it is separated into plasma, red blood cells, and buffy coat. Most of the platelets in the whole blood remain in the processing chamber 52 as part of the buffy coat along with some white blood cell populations (such as mononuclear cells), while larger white blood cells such as granulocytes may exit along with the packed red blood cells. In addition to the buffy coat, the fluid remaining in the processing chamber 52 may also contain some plasma and some red blood cells.

[0059] At least a portion of the separated plasma exits the processing chamber 52 via the plasma outlet port and associated line L3. Valve 38a is closed, which directs the plasma from line L3 to line L7, through the open clamp 24c, and into the plasma collection container 48.

[0060] With respect to the separated red blood cells, at least some of them exit the processing chamber 52 via the red blood cell exit port and associated line L4. The additive pump 20 is operated by the control unit to draw the additive solution (in one exemplary embodiment, ADSOL®, but may be other red blood cell additives) from the additive solution container 42 via line L10. The red blood cells flowing through line L4 are mixed with the additive solution flowing through line L10 at the junction of the two lines L4 and line L10, forming a mixture that flows into line L5 and continues to flow through line L5. The mixture is ultimately directed to the red blood cell collection container 46, but may first be carried through a leukocyte reduction filter 62 (if provided), as shown in Figure 6. Even if a leukocyte reduction filter 62 is provided, the valve system may be controlled, as shown in Figure 7, to allow the mixture to bypass the leukocyte reduction filter 62 and enter the red blood cell collection container 46 without leukocyte reduction. It is also within the scope of this disclosure that the mixture is routed through the leukocyte reduction filter 62 at the start of the collection step, and that the valve system is reconfigured during the collection step so that the mixture bypasses the leukocyte reduction filter 62 so that only a portion of the collected red blood cells are leukocyte-reduced.

[0061] In the configuration shown in Figure 6 (where the mixture is leukocyte-reduced), valves 38a, 38b, and 38c are closed, and valve 38d is open, allowing the mixture to flow from line L5 to line L11. The mixture flows through the open valve 38d and the leukocyte-reducing filter 62 and enters line L12. The leukocyte-reduced mixture then flows through the open clamp 24a and enters the red blood cell collection container 46.

[0062] In the configuration shown in Figure 7 (where the mixture is not leukocyte-reduced), valves 38a, 38c, and 38d are closed, and valve 38b is open, allowing the mixture to flow from line L5 to line L8, and then to line L13. The mixture flows through the open valve 38b to line L12, bypassing the leukocyte-reduced filter 62. The non-leukocyte-reduced mixture then flows through the open clamp 24a and into the red blood cell collection container 46.

[0063] As described above, the mixture may be routed to pass through the leukocyte reduction filter 62 at the start of the collection phase (as shown in Figure 6), and the valve system may be reconfigured during the collection phase so that the mixture bypasses the leukocyte reduction filter 62 (as shown in Figure 7) so that only a portion of the collected red blood cells are leukocyte-reduced. In one embodiment, a pressure sensor 40b monitors the pressure of the leukocyte reduction filter 62. If the pressure sensor 40b detects that the pressure of the leukocyte reduction filter 62 has risen above a predetermined pressure threshold (which may indicate blockage of the filter), the control unit may reconfigure the valve system so that the mixture bypasses the leukocyte reduction filter 62 (from the configuration in Figure 6 to the configuration in Figure 7). The system may then warn the operator that the red blood cell product is not leukocyte-reduced.

[0064] Regardless of whether the collected red blood cells have undergone (or are only partially undergone) leukocyte reduction, the collection phase continues until a target amount of whole blood (which may be one unit of whole blood or any other amount) is taken up into the fluid flow circuit 12 from the blood source. If a whole blood container 44 is used as the blood source (as in the illustrated embodiment), the collection phase ends when the whole blood container 44 (which is initially supplied with one unit of whole blood) is empty, by various approaches that may be used to determine when the whole blood container 44 is empty. For example, in one embodiment, a pressure sensor 40c monitors the hydrostatic pressure of the whole blood container 44. An empty whole blood container 44 may be detected when the hydrostatic pressure measured by the pressure sensor 40c is below a threshold. Alternatively (or additionally), the weight of the whole blood container 44 may be monitored by a weighing scale, and an empty whole blood container 44 may be detected when the weight is below a threshold. In the case of a living donor (or when two or more units of blood are supplied to the whole blood container 44), the volumetric flow rate of the whole blood pump 16 can be used to determine when one unit of whole blood was drawn into the fluid flow circuit 12.

[0065] At the end of the collection stage, the buffy coats are isolated in the processing chamber 52 and can be easily collected. The buffy coats can then be pooled with 3-4 additional buffy coats (4-5 in total) and further separated to produce clean platelet products. However, it may be advantageous to instead collect platelets (concentrated platelets) from the processing chamber 52 in a way that does not require further (secondary) processing to produce platelet products. By collecting platelet concentrates instead of buffy coats, no further platelet loss occurs during the secondary procedures required after pooling multiple buffy coats. Because of the reduced platelet loss, it may be possible to process fewer units of blood to produce platelet products. This may include platelet products formed by combining concentrated platelets from 3-4 units of blood, rather than requiring 4-5 units to produce equivalent platelet products using pooled buffy coats.

[0066] To collect the platelet concentrate, the control unit terminates the collection phase and moves to the “platelet resuspension” phase. In one exemplary embodiment, the platelet resuspension phase has two distinct stages: the fluid in the processing chamber 52 (including the buffy coat) is mixed in the first stage to form a homogeneous fluid, and then in the second stage the fluid is separated into platelet concentrate and red blood cells. The two-stage platelet resuspension phase is described in more detail below, but this is merely illustrative and it should be understood that the platelet resuspension phase may have different stages or different numbers of stages as is within the scope of this disclosure.

[0067] In the first stage of the exemplary two-stage platelet resuspension stage, the pump and valve systems return to the state they were in during the separation establishment stage, as shown in Figure 5. The fluid flow is guided along the same path through the fluid flow circuit 12 between the separation establishment stage and the first stage of the platelet resuspension stage, although it will be understood that the composition of the fluid moving through the fluid flow circuit 12 is not the same. Furthermore, the centrifuge 22 rotates at different speeds between the separation establishment stage and the first stage of the platelet resuspension stage (as described later), so that the fluid is separated during the separation establishment stage but mixed during the first stage of the platelet resuspension stage.

[0068] More specifically, to transition from the collection phase to the first phase of the platelet resuspension phase, clamps 24a and 24c are closed (along with valves 38b and 38d) to prevent further collection of the separated plasma and separated red blood cells. The whole blood pump 16 and plasma pump 20 remain operating, but the additive pump 20 is stopped, valves 38a and 38c are opened, and the fluid circulates through the processing chamber 52 as described above with respect to the separation establishment phase. In this first phase of the platelet resuspension phase, the whole blood pump 16 may rotate faster than the plasma pump 18 (which may operate at 80 mL / min in the same example) (at 100 mL / min in one example). The difference in operating speeds between the two pumps 16,18 is the speed at which the fluid exits the processing chamber 52 through line L4 (i.e., 20 mL / min in the example).

[0069] The centrifuge 22 operates during the separation establishment phase (and subsequent collection phase), but does not operate during the first phase of the platelet resuspension phase, thus preventing the processing chamber 52 from rotating. This allows the fluid within the processing chamber 52 (including the buffy coat) to circulate and mix, eventually forming a homogeneous mixture. The homogeneous mixture has a hematocrit in the range of approximately 40–60% and a platelet concentration of approximately 2000 e3 / μL, and the exact composition of the mixture depends in part on the composition of the whole blood being processed.

[0070] The first stage of the resuspension phase can be continued for a predetermined time known to effectively mix the fluid. Alternatively, the first stage can be continued until the optical sensor 34 detects a homogeneous mixture in lines L2, L3, and L4 and determines that the resuspension was effective. In either case, after confirming that a suitable homogeneous mixture has been formed, the control unit proceeds to the second stage of the resuspension phase.

[0071] During the second stage of platelet resuspension (the pump and valve system can be configured as in the first stage and as shown in Figure 5), the centrifuge 22 begins to rotate to facilitate the separation of a homogeneous fluid. The centrifuge 22 rotates at a "hard spin" (approximately 4,500 to 5,500 rpm) during the separation establishment and collection stages, but rotates more slowly during the second stage of platelet resuspension (for example, in the range of 2,000 to 3,000 rpm, which can be considered a "soft spin"). A slower rotation speed allows for the separation of a homogeneous fluid into plasma and red blood cell fractions, but does not generate enough g to cause platelet sedimentation, so platelets may remain in the plasma fraction and form a platelet concentrate. The flow rates of the separated fluid fractions exiting the processing chamber 52 via lines L3 and L4 may remain the same as during the first stage of the platelet resuspension step, or they may be set to different levels, either of which may include flow rates that are adjusted (if necessary) stepwise until the fluid exiting the processing chamber 52 via line L3 no longer contains red blood cells.

[0072] Through the second stage of platelet resuspension, the platelet concentrate exiting the processing chamber 52 via line L3 and the red blood cells exiting via line L4 are recombined in line L8 and recirculated through the processing chamber 52 by the whole blood pump 16. The second resuspension stage can continue for a predetermined time known to allow complete resuspension of platelets into the platelet concentrate, or until the optical sensor 34 detects the platelet content of the fluid flowing through line L3 and allows for a transition to the next stage.

[0073] The next step in the procedure is the “platelet collection” step, during which concentrated platelets (including resuspended platelets) are extruded or transported from the processing chamber 52 and collected in the concentrated platelet collection container 64. This can be achieved in one of a number of ways, including using either whole blood from a whole blood source 44 (two variations of such an approach are shown in Figures 8 and 9) or red blood cells separated from a red blood cell collection container 46 (two variations of such an approach are shown in Figures 10 and 11).

[0074] When collecting concentrated platelets using whole blood, clamps 24a and 24b are opened and valves 38a and 38c are closed. Collecting concentrated platelets using whole blood also collects red blood cells. This means that either valve 38b or valve 38d is opened depending on whether or not red blood cells are to be reduced to white blood cells (Figure 8) or not (Figure 9). In either case, whole blood from the blood supply source 44 is delivered to the processing chamber 52 via lines L1 and L2 by the whole blood pump 16. The whole blood pump 16 and the plasma pump 18 (which also operates during the platelet collection stage) can be set to a predetermined constant speed, or the whole blood pump 16 can operate at a constant speed while the operating speed of the plasma pump 18 is changed by the control unit based on input from the interface detector. The centrifuge 22 can continue to rotate the processing chamber 52 at the same speed as during the second stage of the platelet resuspension stage, allowing red blood cells and white blood cells, rather than platelets, to settle from the plasma fraction to produce a platelet concentrate.

[0075] As the newly introduced whole blood separates into red blood cells and plasma (platelet concentrate) in the processing chamber 52, the fresh plasma from the whole blood acts to force the platelet concentrate or upstream plasma fraction (including resuspended platelets) out of the chamber 52 via line L3, through line L6 and the open clamp 24b, into the platelet concentrate collection container 64. Throughout the platelet collection stage, the interface position (thickness of the red blood cell bed) may also be increased by the control unit to further promote the reduction of platelet concentrate from the processing chamber 52.

[0076] With respect to the separated red blood cells, at least some of them exit the processing chamber 52 via the red blood cell exit port and associated line L4. The additive pump 20 is operated by the control unit to draw the additive solution from the additive solution container 42 via line L10, and the red blood cells flowing through line L4 are mixed with the additive solution at the junction of lines L4 and L10 to form a mixture. This flows into line L5 and continues to flow through line L5. As shown in Figure 8, the mixture is eventually directed to the red blood cell collection container 46 and flows through a leukocyte reduction filter 62 (if provided), if applicable. As described above with respect to the collection stage, even if a leukocyte reduction filter 62 is provided, the valve system may be controlled so that the mixture bypasses the leukocyte reduction filter 62 and enters the red blood cell collection container 46 without leukocyte reduction, as shown in Figure 9. This also includes sending the mixture through the leukocyte reduction filter 62 at the start of the platelet collection stage, and the valve system being reconfigured so that the mixture bypasses the leukocyte reduction filter 62 during the platelet collection stage so that only a portion of the collected red blood cells are reduced in leukocytes.

[0077] Regardless of whether red blood cells are reducing the white blood cell count, the platelet collection phase can continue until an action or status triggers termination. For example, the control unit may be configured to terminate the platelet collection phase when the whole blood container 44 is empty, when the optical sensor 34 determines that the platelet concentration in the plasma fraction flowing through line L3 is below a predetermined threshold (indicating that the plasma fraction has moved from the platelet concentrate to the plasma separated from the newly introduced whole blood), when the interface detector detects the interface at the target position, when the optical sensor 34 detects the presence of red blood cells in line L3 (indicating that the whole plasma fraction has been discharged), or in any combination of these events.

[0078] Alternatively, as described above, platelet concentrates can be collected using collected red blood cells instead of whole blood (for example, if all available blood from the blood source has been processed). Two variations of such an approach are shown in Figures 10 and 11. In the variation in Figure 10, the platelet concentrate is collected using the whole blood pump 16, while in the variation in Figure 11, the whole blood pump is not operating. In both variations, clamps 24a and 24b and valve 38b are opened and valve 38a is closed to transition from the platelet resuspension stage to the platelet collection stage. Clamp 38c remains open when the whole blood pump 16 is operating (variation in Figure 10), but is closed when the whole blood pump 16 is not operating (variation in Figure 11).

[0079] In the variation shown in Figure 10, red blood cells are removed from the red blood cell collection container 46 and moved into the processing chamber 52 via both lines L2 and L4. In the illustrated embodiment, the plasma pump 18 must be set to a speed greater than that of the whole blood pump 16 (as there is no pump associated with line L4) so ​​that red blood cells can enter the processing chamber 52 via line L4. The whole blood pump 16 and the plasma pump 18 are set to predetermined speeds (which may be the same as or different from the operating speed at the end of the platelet resuspension step), while the centrifuge 22 continues to rotate the processing chamber 52 at a calculated speed that allows red and white blood cells to settle from the plasma fraction to produce a platelet concentrate, but does not cause platelets to settle.

[0080] In the modified form of Figure 11 (where the whole blood pump 16 is inactive and valve 38c is closed), some of the red blood cells leaving the red blood cell collection container 46 enter the processing chamber 52 via line L4. The plasma pump 18 can be set to any appropriate speed, either the same as or different from the operating speed at the end of the platelet resuspension stage. As with other variations of the platelet collection stage, the centrifuge 22 continues to rotate the processing chamber 52 at a calculated speed to produce a platelet concentrate.

[0081] In both variations, the red blood cells entering the processing chamber 52 act to increase the thickness of the red blood cell bed, and thus discharge the platelet concentrate from the chamber 52 to the platelet concentrate collection container 64 via line L3, line L6, and the open clamp 24b. When used, the platelet collection step using red blood cells can be terminated on conditions similar to those described above for variations using whole blood to collect platelet concentrate (for example, when the red blood cell collection container 46 is empty and / or when the optical sensor 34 detects the presence of red blood cells in line L3).

[0082] In any variation of the platelet collection stage, the optical sensor 34 can estimate the platelet concentration in the fluid within the platelet concentrate collection container 64. The platelet concentration can be multiplied by the volume of the fluid within the platelet concentrate collection container 64 (which can be determined, for example, using a weighing scale) to estimate the amount of platelets in the platelet concentrate collection container 64. This information can be used to enable efficient pooling of large quantities of platelet concentrate. For example, if three concentrated platelet collection containers with estimated platelet counts of 1.1e11, 1.3e11, and 0.9e11 are available, the platelet product can be formed by pooling only these three volumes of concentrated platelets. On the other hand, if three concentrated platelet collection containers with estimated platelet counts of 0.7e11, 0.8e11, and 0.8e11 are available, an additional amount of concentrated platelets (ideally, those with relatively low platelet counts, such as 0.8e11) will also be needed to achieve the therapeutic dose threshold of 3.0e11. Thus, it can be seen that the ability to estimate platelet counts for pooling purposes enables significant procedural and financial benefits.

[0083] After the platelet resuspension and platelet collection steps, the control unit moves the procedure to the "red blood cell recovery" step. During the red blood cell recovery step, air from the plasma collection container 48 (transported during the blood priming step) is used to recover red blood cells from the processing chamber 52, reducing product loss. Figure 12 shows a variation of the red blood cell recovery step where the recovered red blood cells are leukocyte-depleted, while Figure 13 shows a variation where they are not leukocyte-depleted.

[0084] In both variations shown, the whole blood pump 16 is deactivated (if not already deactivated, as in the platelet collection stage variation shown in Figure 11) while the plasma pump 18 is operated in the reverse direction (with respect to the direction of operation up to this stage of the procedure). This draws air from the plasma collection container 48 into line L7. With valve 38a closed and clamp 24c open, the air passes through line L7, through line L3, and into the processing chamber 52 via the plasma outlet port. As the air flows through the plasma outlet port, it enters the processing chamber 52 on the low-g side. Once additional air is introduced into the processing chamber 52, the air moves from the low-g wall to the high-g wall, and thus the liquid contents move through the red blood cell outlet port on the high-g side into line L4. During this stage, the centrifuge 22 may be operated at a slower speed (e.g., in the range of approximately 1,000–2,000 rpm) to reduce the risk of air blockage (as during the blood priming stage).

[0085] The additive pump 20 is activated (it is activated in the modified platelet collection stage shown in Figures 8 and 9, but not yet activated), drawing the additive solution from the additive solution container 42 through line L10, and mixing it with the contents of the processing chamber 52 flowing through line L4 at the junction of the two lines L4 and line L10. The mixture flows into line L5 and continues to flow through line L5. Depending on whether the fluid is leukocyte-reduced (Figure 12) or not (Figure 13), the valve system is positioned in an appropriate configuration to direct the mixture towards the red blood cell collection container 46. As described above with respect to the collection stage, the control unit can change the configuration of the valve system from the configuration shown in Figure 12 to the configuration in Figure 13 during the red blood cell collection stage to stop leukocyte-reducing of red blood cells (for example, if the pressure of the leukocyte-reducing filter 62 becomes too high).

[0086] Regardless of whether the mixture is filtered, it flows into line L12, through the open clamp 24a, and into the red blood cell collection container 46. The red blood cell recovery stage continues until the red blood cells are reduced from the processing chamber 52. This can be determined in any of a number of ways without departing from the scope of this disclosure. In one embodiment, the red blood cell recovery stage continues until a predetermined amount of fluid (corresponding to the amount of red blood cells remaining in the processing chamber 52) is carried out of the processing chamber 52. This amount can be calculated by determining the amount of red blood cells present in the processed blood volume (one unit in one embodiment), which can be determined, for example, based on the hematocrit of the blood. The amount of red blood cells already transported to the red blood cell collection container 46 (which can be determined based on the weight of the red blood cell collection container 46 and the additive solution container 42 at the end of the platelet collection stage) is subtracted from the calculated amount to calculate the amount of red blood cells remaining in the processing chamber 52. In another embodiment, the red blood cell recovery step can be continued until the optical sensor 34 detects a non-red blood cell fluid (e.g., air) flowing through line L4.

[0087] Once the red blood cell retrieval stage is complete, the procedure moves to the “additive solution flush” stage, with two variations shown in Figures 14 and 15. During the additive solution flush stage, the additive solution from the additive solution container 42 is transported to the red blood cell collection container 46 until a target amount of additive solution enters the red blood cell collection container 46. The only change in the transition from the red blood cell retrieval stage to the additive solution flush stage is to deactivate the plasma pump 18 to prevent plasma from being reduced from the plasma collection container 48 (although it is also possible for the additive pump 20 to operate at a different speed). Thus, if the valve system is configured to direct the flow through the leukocyte reduction filter 62 at the end of the red blood cell retrieval stage (as in Figure 12), the additive solution flush stage proceeds as shown in Figure 14. On the other hand, if the valve system is configured to bypass the leukocyte reduction filter 62 at the end of the red blood cell retrieval stage (as in Figure 13), the additive solution flush stage proceeds as shown in Figure 15. If the additive solution is pumped through the leukocyte reduction filter 62 during the additive solution flushing stage (as shown in Figure 14), the additive solution flowing through line L11 flushes any remaining red blood cells in the leukocyte reduction filter 62 into the red blood cell collection container 46 (in addition to achieving an appropriate amount of additive solution for red blood cell production). However, if the control unit determines that it is desirable to initiate a bypass of the leukocyte reduction filter 62, it is also within the scope of this disclosure that valve 38b is closed and valve 38d is opened at the end of the red blood cell collection stage (as shown in Figure 12), and that valve 38b is opened and valve 38d is closed at the beginning of the additive solution flushing stage (as shown in Figure 15). Furthermore, it is within the scope of this disclosure to configure the valve system as shown in Figure 14 at the start of the additive solution flushing stage (to direct the additive solution towards the leukocyte reduction filter 62) and transition to the configuration shown in Figure 15 before the end of the additive solution flushing stage (to allow the additive solution to bypass the leukocyte reduction filter 62).

[0088] The additive solution flushing stage continues until a target amount of additive solution is added to the red blood cell collection container 46. In one exemplary embodiment, the weight of the additive solution container 42 can be monitored by a weighing scale and has a specific change in weight corresponding to the target amount of additive solution delivered to the red blood cell collection container 46. Alternatively (or additionally), the weight of the red blood cell collection container 46 can be monitored by a weighing scale and has a specific change in weight corresponding to the target amount of additive solution delivered to the red blood cell collection container 46.

[0089] Once the additive solution flushing stage is complete, the system moves to the “air purging” stage as shown in Figure 16. During the air purging stage, the red blood cell collection container 46 is “burped” to reduce all residual air for preservation (just as air was purged from the plasma collection container 48 during the red blood cell recovery stage). This is done by reversing the direction of operation of the additive pump 20, closing valve 38d (if it is not already closed at the end of the additive solution flushing stage), and opening valve 38b (if it is not already open at the end of the additive solution flushing stage). The additive pump 20 draws air from the red blood cell collection container 46 through line L12 and open clamp 24a, and through line L13 and open valve 38b. The air continues through lines L8, L5, and L10, and the air ends up in the additive solution container 42. Figure 16 shows air being discharged from the red blood cell collection container 46 to the additive solution container 42, but it is within the scope of this disclosure that all or part of the air may be directed to different locations in the fluid flow circuit 12 (e.g., into the processing chamber 52 and / or into the whole blood container 44, if provided).

[0090] The air removal stage continues until all air is removed from the red blood cell collection container 46, which can be determined by detecting a change in the weight of the red blood cell collection container 46 (for example, using a weighing scale).

[0091] Once the air venting stage is complete, any of a number of post-processing stages can be performed. For example, Figure 17 shows the “sealed” stage, in which all clamps and valves are closed and all pumps are stopped (deactivated). Line L12 connected to the red blood cell collection container 46, line L7 connected to the plasma collection container 48, and line L6 connected to the platelet concentrate collection container 64 are sealed for the storage of the plasma, red blood cells, and platelet concentrate products and cut as needed. If lines L6, L7, and L12 are cut, the plasma collection container 48, platelet concentrate collection container 64, and red blood cell collection container 46 can be stored, but the rest of the fluid flow circuit 12 is discarded. Lines L6, L7, and L12 may be sealed (and optionally cut) according to any suitable approach, which may include, for example, being incorporated into clamps 24a, 24b, and 24c or being sealed by associated RF sealers. In another embodiment, the fluid flow circuit 12 is removed from the processing apparatus 10, and lines L6, L7, and L12 are sealed (and optionally cut) using a dedicated sealing device.

[0092] manner Appearance 1 A blood processing system comprising a reusable processing unit and a disposable fluid flow circuit, wherein the reusable processing unit includes a pump system, a valve system, a centrifuge, and a control unit, and the disposable fluid flow circuit includes a processing chamber received by the centrifuge, a red blood cell collection container, a platelet concentrate collection container, and a plurality of tubes fluidly connected to the components of the fluid flow circuit, the control unit commands the pump system and valve system to cooperate in transporting whole blood from a blood source to the processing chamber, the centrifuge operates to separate the whole blood in the processing chamber into plasma and red blood cells, transports the separated plasma and red blood cells from the processing chamber, recombines the separated plasma and red blood cells as recombined whole blood, and performs a separation establishment step in which the pump system and valve system cooperate in transporting the recombined whole blood to the processing chamber, the pump system transports whole blood from a blood source to the processing chamber, and the centrifuge separates the whole blood in the processing chamber into plasma, buffy coat A blood processing system configured to separate plasma into red blood cells, and to perform a platelet resuspension step comprising a first step in which the pump system and valve system cooperate to transport at least a portion of the separated plasma out of the processing chamber and at least a portion of the separated red blood cells from the processing chamber into a red blood cell collection container, leaving the fluid including the buffy coat in the processing chamber, and a second step in which the centrifuge is stopped and the pump system and valve system cooperate to circulate the fluid in the processing chamber through a fluid flow circuit to form a homogeneous mixture, and a second step in which the centrifuge operates to separate the homogeneous mixture into platelet concentrate and red blood cells, and a platelet collection step in which the pump system and valve system cooperate to transport whole blood from a blood source or at least a portion of the contents of a red blood cell collection container into the processing chamber to transport at least a portion of the platelet concentrate from the processing chamber into a platelet concentrate collection container.

[0093] Appearance 2 The blood processing system according to embodiment 1, wherein the fluid flow circuit includes a whole blood container containing one unit of whole blood, and the blood source is the whole blood container.

[0094] Appearance 3 The blood processing system according to embodiment 2, wherein the processing device includes a first pressure sensor configured to measure the hydrostatic pressure of a whole blood container, and the control unit is configured to terminate the collection step at least in part based on the hydrostatic pressure of the whole blood container.

[0095] Pattern 4 A blood processing system according to embodiment 2 or 3, wherein the processing device includes a first weighing scale configured to measure the weight of a whole blood container, and the control unit is configured to terminate the collection step partially based on the weight of the whole blood container.

[0096] Appearance 5 The blood processing system according to embodiment 1, wherein the blood source is a living donor.

[0097] Appearance 6 A blood processing system according to any one of embodiments 1 to 5, wherein the processing device includes an interface detector configured to determine the position of interfaces between separated blood components in a processing chamber, and the control unit is configured to terminate the separation establishment step when the interface detector determines that the interface is at a target position and the control unit determines that steady-state separation has been achieved.

[0098] Appearance 7 A blood processing system according to any one of embodiments 1 to 6, wherein the processing device includes a leukocyte reduction filter, and the pump system and valve system cooperate to transport at least a portion of the separated red blood cells through the leukocyte reduction filter before being transported into a red blood cell collection container during at least part of the collection stage.

[0099] Appearance 8 The blood processing system according to embodiment 7, wherein the processing device includes a second pressure sensor configured to measure the pressure of a leukocyte reduction filter, and the control unit is configured to control a valve system to direct at least a portion of the separated red blood cells to a red blood cell collection container without first passing through the leukocyte reduction filter, at least partially based on the pressure of the leukocyte reduction filter.

[0100] Appearance 9 A blood processing system according to any one of embodiments 1 to 8, wherein the processing device includes an optical sensor configured to monitor the fluid leaving the processing chamber, and the control unit is configured to terminate the platelet collection step when the optical sensor detects that the non-platelet concentrate fluid has left the processing chamber.

[0101] Appearance 10 A blood processing system according to any one of embodiments 1 to 9, wherein during the platelet collection stage, a pump system and a valve system cooperate to transport whole blood from the blood source into the processing chamber, a centrifuge operates to separate the whole blood in the processing chamber into platelet-rich plasma and red blood cells, and the platelet-rich plasma pushes at least a portion of the platelet concentrate out of the processing chamber into a platelet concentrate collection container.

[0102] Appearance 11 A blood processing system according to any one of embodiments 1 to 9, wherein, during the platelet collection stage, a pump system and a valve system cooperate to transport at least a portion of the contents of a red blood cell container into the processing chamber in order to push at least a portion of the platelet concentrate from the processing chamber into a platelet concentrate collection container.

[0103] Appearance 12 The blood processing system according to any one of embodiments 1 to 11, wherein the control unit is further configured to perform a blood priming step in which a pump system transports whole blood from a blood source to a processing chamber in order to transport air in the fluid flow circuit into a plasma collection container of the fluid flow circuit.

[0104] Appearance 13 The blood processing system according to embodiment 12, wherein the control unit is further configured to perform a red blood cell recovery step in which a pump system and a valve system cooperate to transport air from a plasma collection container into a processing chamber in order to transport separated red blood cells from the processing chamber into a red blood cell collection container.

[0105] Appearance 14 A blood processing system according to any one of embodiments 1 to 13, wherein the fluid flow circuit includes an additive solution container, and a pump system and a valve system cooperate to transport the additive solution from the additive solution to combine it with separated red blood cells transported into a red blood cell collection container.

[0106] Appearance 15 The blood processing system according to embodiment 14, wherein the control unit is further configured to perform an additive solution flushing step after the platelet collection step, in which the pump system and valve system cooperate to transport the additive solution from the additive solution container to the red blood cell collection container until a target amount of the additive solution is transported into the red blood cell collection container.

[0107] Appearance 16 The blood processing system according to any one of embodiments 1 to 15, wherein the control unit is further configured to perform an air removal step after the platelet collection step, in which the pump system and valve system cooperate to remove air from the platelet collection container.

[0108] Appearance 17 A blood processing system according to any one of embodiments 1 to 16, wherein the processing device includes a sealing system, and the control unit is configured to control the sealing system to seal a first tube connected to a red blood cell collection container and a second tube connected to a platelet concentrate collection container after a platelet collection step.

[0109] Appearance 18 A blood processing system according to any one of embodiments 1 to 17, wherein the centrifuge operates at a lower rate during the second stage of the platelet resuspension stage than during the collection stage.

[0110] Appearance 19 A blood processing system according to any one of embodiments 1 to 18, wherein the processing device includes an optical sensor configured to monitor a fluid leaving the processing chamber, and the control unit is configured to terminate the first stage of the platelet resuspension step when the optical sensor detects a homogeneous mixture leaving the processing chamber.

[0111] Appearance 20 A blood processing system according to any one of embodiments 1 to 19, wherein the processing device includes an optical sensor configured to monitor a fluid leaving the processing chamber, and the control unit is configured to terminate the second stage of the platelet resuspension step when the optical sensor detects a platelet concentrate having a target platelet concentration leaving the processing chamber.

[0112] Appearance 21 A method for processing whole blood into red blood cell products, plasma products and platelet products, comprising: transporting whole blood from a blood source to a processing chamber of a fluid flow circuit; operating a centrifuge to separate the whole blood in the processing chamber into plasma and red blood cells; transporting the separated plasma and red blood cells from the processing chamber and recombining them as recombined whole blood; and performing a separation establishment step in which the recombined whole blood is transported to the processing chamber; whole blood is transported from a blood source to the processing chamber; a centrifuge operates to separate the whole blood in the processing chamber into plasma, buffy coat, and red blood cells; at least a portion of the separated plasma is transported out of the processing chamber; and at least a portion of the separated red blood cells is transported from the processing chamber into a red blood cell collection container of a fluid flow circuit. A method for processing whole blood into erythrocyte products, plasma products and platelet products, comprising: a first step of performing a collection step in which a fluid containing a buffy coat remains in the processing chamber, and a platelet resuspension step comprising a first step of stopping the centrifuge to circulate the fluid in the processing chamber through a fluid flow circuit to form a homogeneous mixture, and a second step of performing a platelet resuspension step comprising a second step of operating the centrifuge to separate the homogeneous mixture into platelet concentrate and erythrocytes; and a platelet collection step comprising transporting whole blood from a blood source or at least a portion of the contents of an erythrocyte collection container to the processing chamber in order to transport at least a portion of the platelet concentrate from the processing chamber into a platelet concentrate collection container of a fluid flow circuit.

[0113] Appearance 22 The method according to embodiment 21, wherein the platelet collection step includes transporting whole blood from a blood source into a processing chamber, operating a centrifuge to separate the whole blood in the processing chamber into platelet-rich plasma and red blood cells, and pushing at least a portion of the platelet concentrate from the processing chamber into a platelet concentrate collection container.

[0114] Appearance 23 The method according to embodiment 21, wherein the platelet collection step includes transporting at least a portion of the contents of the red blood cell container into the processing chamber in order to push at least a portion of the platelet concentrate out of the processing chamber into the platelet concentrate collection container.

[0115] Pattern 24 The method according to any one of embodiments 21 to 23, wherein the fluid flow circuit includes a whole blood container containing one unit of whole blood, and the blood source is the whole blood container.

[0116] Appearance 25 The method according to embodiment 24, wherein the execution of the collection step includes measuring the hydrostatic pressure of the whole blood container and terminating the collection step at least in part based on the hydrostatic pressure of the whole blood container.

[0117] Appearance 26 The method according to aspect 24 or aspect 25, wherein the execution of the collection step includes measuring the weight of the whole blood container and terminating the collection step partially on the weight of the whole blood container.

[0118] Appearance 27 The method according to any one of embodiments 21 to 23, wherein the blood source is a living donor.

[0119] Appearance 28 The method according to any one of embodiments 21 to 27, wherein the execution of the separation establishment step includes determining the location of the interface between the separated blood components in the processing chamber and terminating the separation establishment step when it is determined that the interface is at the target location and steady-state separation has been achieved.

[0120] Appearance 29 The method according to any one of embodiments 21 to 28, wherein the execution of the collection step includes, for at least a portion of the collection step, transporting at least a portion of the separated red blood cells through a leukocyte reduction filter before they are transported into a red blood cell collection container.

[0121] Appearance 30 The method according to embodiment 29, wherein the execution of the collection step includes measuring the pressure of the leukocyte reduction filter and directing at least a portion of the separated red blood cells to a red blood cell collection container without first passing through the leukocyte reduction filter, at least partially based on the pressure of the leukocyte reduction filter.

[0122] Appearance 31 The method according to any one of embodiments 21 to 30, wherein the execution of the platelet collection step includes monitoring the fluid leaving the processing chamber and terminating the platelet collection step when it is detected that the fluid of the non-platelet concentrate has left the processing chamber.

[0123] Appearance 32 The method according to any one of embodiments 21 to 31, further comprising performing a blood priming step in which whole blood is transported from a blood source to a processing chamber of the fluid flow circuit in order to transport air in the fluid flow circuit into a plasma collection container of the fluid flow circuit.

[0124] Appearance 33 The method according to embodiment 32, further comprising performing a red blood cell recovery step in which air is transported from the plasma collection container into the processing chamber in order to transport the separated red blood cells from the processing chamber into a red blood cell container.

[0125] Appearance 34 The method according to any one of embodiments 21 to 33, further comprising transporting an additive solution from the additive solution in a fluid flow circuit to combine it with the separated red blood cells transported into a red blood cell collection container.

[0126] Appearance 35 The method according to embodiment 34, further comprising performing an additive solution flush step of transferring the additive solution from the additive solution container to the red blood cell collection container until a target amount of the additive solution is transferred to the red blood cell collection container.

[0127] Appearance 36 The method according to any one of embodiments 21 to 35, further comprising performing an air removal step of removing air from the platelet collection container.

[0128] Appearance 37 Furthermore, the method according to any one of embodiments 21 to 36, further comprising sealing a first tube connected to a red blood cell collection container and sealing a second tube connected to a platelet concentrate collection container after the platelet collection step.

[0129] Appearance 38 The method according to any one of embodiments 21 to 37, wherein the platelet resuspension step includes operating a centrifuge at a lower rate during the second step of the platelet resuspension step than during the collection step.

[0130] Appearance 39 The method according to any one of embodiments 21 to 38, further comprising monitoring the fluid leaving the processing chamber and terminating the first step of the platelet resuspension step when a homogeneous mixture leaving the processing chamber is detected.

[0131] Pattern 40 Furthermore, the blood processing system according to any one of embodiments 21 to 39, comprising monitoring the fluid leaving the processing chamber and terminating the second stage of the platelet resuspension step when a platelet concentrate having a target platelet concentration is detected leaving the processing chamber.

[0132] Appearance 41 A blood processing device comprising a pump system, a valve system, a centrifuge, and a control unit, wherein the control unit commands the pump system and valve system to cooperate in transporting whole blood from a blood source to a centrifuge, the centrifuge operates to separate the whole blood in the centrifuge into plasma and red blood cells, the separated plasma and red blood cells are transported out of the centrifuge, the separated plasma and red blood cells are recombined as recombined whole blood, and the pump system and valve system cooperate in transporting the recombined whole blood back to the centrifuge, the pump system transports whole blood from a blood source to the centrifuge, the centrifuge separates the whole blood in the centrifuge into plasma, buffy coat, and red blood cells, and the pump system and valve system transport at least a portion of the separated plasma out of the centrifuge, A blood processing apparatus configured to perform a platelet resuspension stage comprising a first stage in which the centrifuge stops operating and a pump system and valve system cooperate to transport at least a portion of the separated red blood cells from the centrifuge for collection and leave the fluid containing the buffy coat in the centrifuge, and the centrifuge stops operating and a pump system and valve system cooperate to circulate the fluid in the centrifuge through a fluid flow circuit to form a homogeneous mixture, and a second stage in which the centrifuge operates to separate the homogeneous mixture into platelet concentrate and red blood cells, and a platelet collection stage in which a pump system and valve system cooperate to transport whole blood from a blood source or at least a portion of the collected red blood cells to the centrifuge in order to transport at least a portion of the platelet concentrate from the centrifuge for collection.

[0133] Pattern 42 The blood processing apparatus according to embodiment 41, wherein the blood source is a whole blood container.

[0134] Appearance 43 A blood processing apparatus according to embodiment 42, comprising a first pressure sensor configured to measure the hydrostatic pressure of a whole blood container, wherein a control unit is configured to terminate the collection step at least in part based on the hydrostatic pressure of the whole blood container.

[0135] 44 A blood processing apparatus according to embodiment 42 or 43, comprising a first weighing scale configured to measure the weight of a whole blood container, wherein a control unit is configured to terminate the collection step partially on the weight of the whole blood container.

[0136] Appearance 45 The blood processing apparatus according to embodiment 41, wherein the blood source is a living donor.

[0137] Appearance 46 Furthermore, the blood processing apparatus according to any one of embodiments 41 to 45, further comprising an interface detector configured to determine the position of the interface between separated blood components in a centrifuge, wherein the control unit is configured to terminate the separation establishment step when the interface detector determines that the interface is at the target position and the control unit determines that steady-state separation has been achieved.

[0138] Appearance 47 A blood processing apparatus according to any one of embodiments 41 to 46, wherein the control unit is configured to instruct the pump system and valve system to cooperate in transporting at least a portion of the separated red blood cells, after they have been transported from the centrifuge during at least a portion of the collection stage, through a leukocyte reduction filter.

[0139] 48 The blood processing apparatus according to embodiment 47, further comprising a second pressure sensor configured to measure the pressure of the leukocyte reduction filter, wherein the control unit is configured to control a valve system to guide at least a portion of the red blood cells separated from the centrifuge without first passing through the leukocyte reduction filter, at least partially based on the pressure of the leukocyte reduction filter.

[0140] Appearance 49 Furthermore, the blood processing apparatus according to any one of embodiments 41 to 48, further comprising an optical sensor configured to monitor the fluid leaving the centrifuge, and the control unit configured to terminate the platelet collection step when the optical sensor detects that the non-platelet concentrate fluid is leaving the centrifuge.

[0141] Appearance 50 During the platelet collection stage, a pump system and a valve system cooperate to transport whole blood from a blood source into a centrifuge, the centrifuge operates to separate the whole blood into platelet-rich plasma and red blood cells, and the platelet-rich plasma pushes at least a portion of the platelet concentrate out of the centrifuge for collection, as described in any one of embodiments 41 to 49.

[0142] Appearance 51 A blood processing apparatus according to any one of embodiments 41 to 49, wherein, during the platelet collection stage, a pump system and a valve system cooperate to transport at least a portion of the collected red blood cells into the centrifuge in order to push at least a portion of the platelet concentrate out of the centrifuge for collection.

[0143] Appearance 52 The blood processing apparatus according to any one of embodiments 41 to 51, wherein the control unit is further configured to perform a blood priming step in which a pump system transports whole blood from a blood source to a centrifuge in order to transport air out of the centrifuge.

[0144] Appearance 53 The blood processing apparatus according to embodiment 52, wherein the control unit is further configured to perform a red blood cell recovery step in which a pump system and a valve system cooperate to transport air into the centrifuge for collection of separated red blood cells from the centrifuge.

[0145] Phenomenon 54 A blood processing apparatus according to any one of embodiments 41 to 53, wherein a pump system and a valve system cooperate to transport an additive solution for combination with separated red blood cells transported from a centrifuge.

[0146] Appearance 55 The blood processing apparatus according to embodiment 54, wherein the control unit is further configured to perform an additive solution flushing step after the platelet collection step, in which the pump system and valve system cooperate to deliver the additive solution until a target amount of the additive solution is added to the collected red blood cells.

[0147] Appearance 56 The blood processing apparatus according to any one of embodiments 41 to 55, wherein the control unit is further configured to perform an air removal step after the platelet collection step, in which the pump system and valve system cooperate to remove air from the collected red blood cells.

[0148] Appearance 57 The blood processing apparatus according to any one of embodiments 41 to 56, further comprising a sealing system, wherein the control unit is configured to control the sealing system to seal a first tube connected to a red blood cell collection container and a second tube connected to a platelet concentrate collection container after the platelet collection step.

[0149] Appearance 58 A blood processing apparatus according to any one of embodiments 41 to 57, wherein the centrifuge operates at a lower rate during the second stage of the platelet resuspension stage than during the collection stage.

[0150] Appearance 59 Furthermore, the blood processing apparatus according to any one of embodiments 41 to 58, comprising an optical sensor configured to monitor the fluid exiting the centrifuge, and a control unit configured to terminate the first stage of the platelet resuspension step when the optical sensor detects a homogeneous mixture exiting the centrifuge.

[0151] Appearance 60 The blood processing system according to any one of embodiments 41 to 59, further comprising an optical sensor configured to monitor the fluid exiting the centrifuge, wherein the control unit is configured to terminate the second stage of the platelet resuspension step when the optical sensor detects a platelet concentrate having a target platelet concentration exiting the centrifuge.

[0152] It will be understood that the embodiments and examples described above illustrate some applications of the principles of the subject matter. Numerous modifications can be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including combinations of features individually disclosed or claimed herein. For these reasons, the scope of this specification is not limited to the above description but is as set forth in the following claims, and the claims may cover the features of this specification, including combinations of features individually disclosed or claimed herein.

Claims

1. 1. A blood processing apparatus comprising: A pump system; A valve system; A centrifuge; A control unit. The control unit is commanding the pump system and the valve system to cooperate to transport whole blood from a blood source to the centrifuge; performing a separation establishing step in which the pump system and the valve system cooperate to operate the centrifuge to separate the whole blood within the centrifuge into plasma and red blood cells, transport the separated plasma and red blood cells from the centrifuge, recombine the separated plasma and red blood cells as recombined whole blood, and transport the recombined whole blood to the centrifuge; performing a collection step in which the pumping system transports the whole blood from the blood source to the centrifuge, the centrifuge separates the whole blood in the centrifuge into plasma, buffy coat, and red blood cells, the pumping system and the valve system cooperating to transport at least a portion of the separated plasma out of the centrifuge, transport at least a portion of the separated red blood cells from the centrifuge for collection, and leave a fluid containing the buffy coat in the centrifuge; performing a platelet resuspension step comprising a first step in which the centrifuge is stopped and the pump system and the valve system cooperate to circulate the fluid within the centrifuge through the centrifuge to form a homogenous mixture, and a second step in which the centrifuge is operated to separate the homogenous mixture into a platelet concentrate and red blood cells; and performing a platelet collection step in which the pump system and the valve system cooperate to transport whole blood from the blood source or at least a portion of collected red blood cells to the centrifuge to transport at least a portion of the platelet concentrate from the centrifuge for collection. Blood processing equipment.

2. 2. The blood processing device of claim 1, wherein the blood source is a whole blood container.

3. a first pressure sensor configured to measure a hydrostatic pressure of the whole blood container; the controller is configured to terminate the collection phase based at least in part on the hydrostatic pressure of the whole blood container. The blood processing apparatus of claim 2 .

4. a first weighing scale configured to measure a weight of the whole blood container; The controller is configured to terminate the collecting step based in part on a weight of the whole blood container. The blood processing apparatus according to claim 2 or 3.

5. 2. The blood processing apparatus of claim 1, wherein the source of blood is a living donor.

6. and an interface detector configured to determine a location of an interface between separated blood components within the centrifuge. the control unit is configured to terminate the separation establishment phase when the interface detector determines that the interface is at a target location and the control unit determines that steady state separation has been achieved.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

7. the controller is configured to command the pump system and the valve system to cooperate to transport at least a portion of the separated red blood cells through a leukoreduction filter after being transported from the centrifuge during at least a portion of the collection stage.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

8. a second pressure sensor configured to measure a pressure in the leukoreduction filter; the controller is configured to control the valve system to direct at least a portion of the separated red blood cells from the centrifuge without first passing through the leukoreduction filter based at least in part on the pressure of the leukoreduction filter.

8. The blood processing device of claim 7.

9. further comprising an optical sensor configured to monitor fluid exiting the centrifuge; the control unit is configured to terminate the platelet collection phase when the optical sensor detects non-platelet concentrate fluid exiting the centrifuge.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

10. A blood processing device as described in any one of claims 1 to 3 or claim 5, wherein the control unit is configured to control the pump system and the valve system to cooperate to transport whole blood from the blood source into the centrifuge during the platelet collection stage, and to control the centrifuge during the platelet collection stage to separate the whole blood into platelet-rich plasma and red blood cells, and to cause the platelet-rich plasma to push at least a portion of the platelet concentrate out of the centrifuge for collection.

11. A blood processing device as described in any one of claims 1 to 3 or claim 5, wherein the control unit is configured to control the pump system and the valve system to cooperate to transport at least a portion of the collected red blood cells into the centrifuge so as to push at least a portion of the platelet concentrate out of the centrifuge for collection during the platelet collection stage.

12. 6. The blood processing device of claim 1, wherein the controller is further configured to perform a blood prime phase in which the pump system transports whole blood from the blood source to the centrifuge to transport air out of the centrifuge.

13. 13. The blood processing device of claim 12, wherein the controller is further configured to perform a red blood cell recovery step in which the pump system and the valve system cooperate to deliver air into the centrifuge to transport separated red blood cells from the centrifuge for collection.

14. A blood processing device as described in any one of claims 1 to 3 or claim 5, wherein the control unit is configured to control the pump system and the valve system to work together to transport an additive solution for combination with separated red blood cells transported from the centrifuge.

15. 15. The blood processing device of claim 14, wherein the controller is further configured to perform an additive solution flush step after the platelet collection step, wherein the controller controls the pump system and the valve system to cooperate to deliver additive solution until a target amount of additive solution is added to the collected red blood cells.

16. 6. The blood processing device of claim 1, wherein the control unit is further configured to perform an air removal step after the platelet collection step, in which the pump system and the valve system cooperate to remove air from the collected red blood cells.

17. It also includes a sealing system. the control unit is configured to control the sealing system to seal a first tube connected to a red blood cell collection container and to seal a second tube connected to a platelet concentrate collection container after the platelet collection stage.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

18. 6. The blood processing apparatus of claim 1, wherein the centrifuge operates at a lower speed during the second of the platelet resuspension stages than during the collection stage.

19. further comprising an optical sensor configured to monitor fluid exiting the centrifuge; the control unit is configured to terminate the first stage of the platelet resuspension phase when the optical sensor detects a homogenous mixture exiting the centrifuge.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

20. further comprising an optical sensor configured to monitor fluid exiting the centrifuge; the control unit is configured to terminate the second stage of the platelet resuspension stage when the optical sensor detects a platelet concentrate exiting the centrifuge having a target platelet concentration.

6. The blood processing apparatus according to claim 1, wherein the blood is passed through a first passageway.

21. 1. A blood processing system comprising a reusable processing device and a disposable fluid flow circuit, The reusable processing device comprises: A pump system; A valve system; A centrifuge; a control unit; The disposable fluid flow circuit comprises: a processing chamber received by the centrifuge; A red blood cell collection container; a platelet concentrate collection container; a plurality of tubes fluidly connected to the components of the fluid flow circuit; The control unit is commanding the pump system and the valve system to cooperate to transport whole blood from a blood source to the processing chamber; performing a separation establishing step in which the pump system and the valve system cooperate to operate the centrifuge to separate the whole blood in the processing chamber into plasma and red blood cells, transport the separated plasma and red blood cells from the processing chamber, recombine the separated plasma and red blood cells as recombined whole blood, and transport the recombined whole blood to the processing chamber; performing a collection step in which the pumping system transports the whole blood from the blood source to the processing chamber, the centrifuge separates the whole blood in the processing chamber into plasma, buffy coat, and red blood cells, and the pumping system and the valve system cooperate to transport at least a portion of the separated plasma out of the processing chamber, transport at least a portion of the separated red blood cells from the processing chamber into the red blood cell collection container, and leave a fluid containing the buffy coat in the processing chamber; performing a platelet resuspension step, the platelet resuspension step comprising a first step in which the centrifuge is deactivated and the pump system and the valve system cooperate to circulate the fluid within the processing chamber through the fluid flow circuit to form a homogenous mixture, and a second step in which the centrifuge is activated to separate the homogenous mixture into a platelet concentrate and red blood cells; a platelet collection step in which the pump system and the valve system cooperate to transport whole blood from the blood source or at least a portion of the contents of the red blood cell collection container to the processing chamber to transport at least a portion of the platelet concentrate from the processing chamber into the platelet concentrate collection container.

22. the fluid flow circuit includes a whole blood container containing a unit of whole blood; the blood source is the whole blood container; 22. The blood processing system of claim 21.

23. the processing device includes a first pressure sensor configured to measure a hydrostatic pressure of the whole blood container; the controller is configured to terminate the collection phase based at least in part on the hydrostatic pressure of the whole blood container.

23. The blood processing system of claim 22.

24. the processing device includes a first weighing scale configured to measure a weight of the whole blood container; The controller is configured to terminate the collecting step based in part on a weight of the whole blood container.

24. A blood processing system according to claim 22 or claim 23.

25. 22. The blood processing system of claim 21, wherein the blood source is a living donor.

26. the processing device includes an interface detector configured to determine a location of an interface between separated blood components within the processing chamber; the control unit is configured to terminate the separation establishment phase when the interface detector determines that the interface is at a target location and the control unit determines that steady state separation has been achieved. A blood processing system according to any one of claims 21 to 23 or claim 25.

27. the treatment device includes a leukoreduction filter; the pump system and the valve system cooperate to transport at least a portion of the separated red blood cells through the leukoreduction filter prior to being transported into the red blood cell collection container during at least a portion of the collection step. A blood processing system according to any one of claims 21 to 23 or claim 25.

28. the processing device includes a second pressure sensor configured to measure a pressure in the leukoreduction filter; the controller is configured to control the valve system to direct at least a portion of the separated red blood cells to the red blood cell collection container without first passing through the leukoreduction filter based at least in part on the pressure of the leukoreduction filter.

28. The blood processing system of claim 27.

29. the processing device includes an optical sensor configured to monitor fluid exiting the processing chamber; the control unit is configured to terminate the platelet collection phase when the optical sensor detects non-platelet concentrate fluid exiting the processing chamber. A blood processing system according to any one of claims 21 to 23 or claim 25.

30. 26. The blood processing system of claim 21, wherein during the platelet collection phase, the pump system and the valve system cooperate to transport whole blood from the blood source into the processing chamber, and the centrifuge operates to separate the whole blood in the processing chamber into platelet-rich plasma and red blood cells, and the platelet-rich plasma pushes at least a portion of the platelet concentrate out of the processing chamber and into the platelet concentrate collection container.

31. 26. The blood processing system of claim 21, wherein the pump system and the valve system cooperate to transport at least a portion of the contents of the red blood cell container into the processing chamber during the platelet collection phase to force at least a portion of the platelet concentrate from the processing chamber into the platelet concentrate collection container.

32. 26. The blood processing system of claim 21, 22 or 23, wherein the controller is further configured to execute a blood prime phase in which the pump system transports whole blood from the blood source to the processing chamber to transport air in the fluid flow circuit into a plasma collection container of the fluid flow circuit.

33. 33. The blood processing system of claim 32, wherein the controller is further configured to execute a red blood cell recovery step in which the pump system and the valve system cooperate to transport air from the plasma collection container into the processing chamber to transport separated red blood cells from the processing chamber into the red blood cell collection container.

34. the fluid flow circuit includes an additive solution container; the pump system and the valve system cooperate to transport an additive solution from the additive solution for combination with the separated red blood cells transported into the red blood cell collection container. A blood processing system according to any one of claims 21 to 23 or claim 25.

35. 35. The blood processing system of claim 34, wherein the controller is further configured to perform an additive solution flush step after a platelet collection step, in which the pump system and the valve system cooperate to deliver additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution is delivered into the red blood cell collection container.

36. 26. The blood processing system of claim 21, wherein the control unit is further configured to perform an air removal step after the platelet collection step, in which the pump system and the valve system cooperate to remove air from the red blood cell collection container.

37. the processing device includes a sealing system; the control unit is configured to control the sealing system to seal a first tube connected to the red blood cell collection container and to seal a second tube connected to the platelet concentrate collection container after the platelet collection stage. A blood processing system according to any one of claims 21 to 23 or claim 25.

38. 26. The blood processing system of claim 21, 22 or 25, wherein the centrifuge operates at a lower speed during the second of the platelet resuspension stages than during the collection stage.

39. the processing device includes an optical sensor configured to monitor fluid exiting the processing chamber; the controller is configured to terminate the first stage of the platelet resuspension stage when the optical sensor detects a homogenous mixture exiting the processing chamber. A blood processing system according to any one of claims 21 to 23 or claim 25.

40. the processing device includes an optical sensor configured to monitor fluid exiting the processing chamber; the control unit is configured to terminate the second stage of the platelet resuspension stage when the optical sensor detects a platelet concentrate exiting the processing chamber and having a target platelet concentration. A blood processing system according to any one of claims 21 to 23 or claim 25.

41. 1. A method for processing whole blood into a red blood cell product, a plasma product, and a platelet product, comprising: conveying whole blood from a blood source to a processing chamber in a fluid flow circuit; performing a separation establishing step in which the centrifuge operates to separate the whole blood in the processing chamber into plasma and red blood cells, transporting the separated plasma and red blood cells from the processing chamber, recombining the separated plasma and red blood cells as recombined whole blood, and transporting the recombined whole blood to the processing chamber; performing a collection step in which the whole blood is transported from the blood source to the processing chamber, the centrifuge is operated to separate the whole blood in the processing chamber into plasma, buffy coat, and red blood cells, at least a portion of the separated plasma is transported out of the processing chamber, at least a portion of the separated red blood cells are transported from the processing chamber into the red blood cell collection container of the fluid flow circuit, and fluid including the buffy coat remains in the processing chamber; performing a platelet resuspension step comprising a first step in which the centrifuge is deactivated to circulate the fluid in the processing chamber through the fluid flow circuit to form a homogenous mixture, and a second step in which the centrifuge is activated to separate the homogenous mixture into a platelet concentrate and red blood cells; performing a platelet collection step of transporting whole blood from the blood source or at least a portion of the contents of the red blood cell collection container to the processing chamber for transporting at least a portion of the platelet concentrate from the processing chamber into the platelet concentrate collection container of the fluid flow circuit. A method for processing whole blood into a red blood cell product, a plasma product, and a platelet product.

42. 42. The method of claim 41, wherein the platelet harvesting step comprises transporting whole blood from the blood source into the processing chamber, operating the centrifuge to separate the whole blood in the processing chamber into platelet-rich plasma and red blood cells, and the platelet-rich plasma pushing at least a portion of the platelet concentrate out of the processing chamber and into the platelet concentrate collection container.

43. 42. The method of claim 41, wherein the platelet collecting step includes conveying at least a portion of the contents of the red blood cell container into the processing chamber to force at least a portion of the platelet concentrate from the processing chamber and into the platelet concentrate collection container.

44. the fluid flow circuit includes a whole blood container containing a unit of whole blood; the blood source is the whole blood container; 44. A method according to any one of claims 41 to 43.

45. The performing of the collecting step includes: measuring the hydrostatic pressure of the whole blood container; terminating the collecting step based at least in part on the hydrostatic pressure of the whole blood container.

45. The method of claim 44.

46. The performing of the collecting step includes: weighing the whole blood container; terminating the collecting step based in part on a weight of the whole blood container.

45. The method of claim 44.

47. 44. The method of any one of claims 41 to 43, wherein the blood source is a live donor.

48. The execution of the separation establishment step includes: determining a location of an interface between separated blood components within the processing chamber; terminating the establishing separation step when it is determined that the interface is at a target location and steady state separation has been achieved.

44. A method according to any one of claims 41 to 43.

49. The performing of the collecting step includes: conveying at least a portion of the separated red blood cells through a leukoreduction filter prior to being conveyed into the red blood cell collection container during at least a portion of the collecting step.

44. A method according to any one of claims 41 to 43.

50. The performing of the collecting step includes: Measuring the pressure in the leukoreduction filter; directing at least a portion of the separated red blood cells to the red blood cell collection container without first passing through the leukoreduction filter based at least in part on the pressure of the leukoreduction filter.

50. The method of claim 49.

51. The platelet collection step is carried out by monitoring fluid exiting the treatment chamber; terminating the platelet collection step upon detecting non-platelet concentrate fluid exiting the processing chamber.

44. A method according to any one of claims 41 to 43.

52. 44. The method of any one of claims 41 to 43, further comprising performing a blood prime step in which whole blood is transported from the blood source to the processing chamber of the fluid flow circuit to transport any air in the fluid flow circuit into a plasma collection container of the fluid flow circuit.

53. 53. The method of claim 52, further comprising performing a red blood cell recovery step in which air is conveyed from the plasma collection container into the processing chamber to transport separated red blood cells out of the processing chamber and into the red blood cell collection container.

54. further comprising conveying an additive solution from an additive solution container in the fluid flow circuit for combination with the separated red blood cells conveyed into the red blood cell collection container.

44. A method according to any one of claims 41 to 43.

55. 55. The method of claim 54, further comprising performing an additive solution flush step of delivering additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution has been delivered into the red blood cell collection container.

56. 44. The method of any one of claims 41 to 43, further comprising performing an air removal step of removing air from the red blood cell collection container.

57. 44. The method of any one of claims 41 to 43, further comprising, after the platelet harvesting step, sealing a first tube connected to the red blood cell collection container and sealing a second tube connected to the platelet concentrate collection container.

58. 44. The method of any one of claims 41 to 43, wherein the platelet resuspension step comprises operating the centrifuge at a lower speed during the second stage of the platelet resuspension step than during the collecting step.

59. further comprising: monitoring fluid exiting the processing chamber; terminating said first stage of said platelet resuspension steps upon detecting a homogenous mixture exiting said processing chamber.

44. A method according to any one of claims 41 to 43.

60. further comprising: monitoring fluid exiting the processing chamber; and terminating the second stage of the platelet resuspension step upon detecting a platelet concentrate having a target platelet concentration that exits the processing chamber.

44. A blood processing system according to any one of claims 41 to 43.

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