A configurable system for automating the blood component manufacturing process.

Abstract

By using continuous flow centrifugation in a system that utilizes a programmable control unit, we provide apparatus, systems, and methods that can be used in whole blood collection and post-collection processing systems. [Solution] The configurable automated blood component production system includes durable hardware components 10 and a disposable fluid flow circuit. The hardware components 10 include a pump station 20, a centrifuge 22, and a control unit including a touchscreen 14. The fluid flow circuit includes a separation chamber housed in the centrifuge 22, a fluid flow control cassette mounted on a cassette nesting module 36, and a plurality of containers that are in fluid communication with the fluid flow cassette. The control unit 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.

Description

Technical Field

[0001] [Related Applications] This application claims the benefit of U.S. Provisional Application No. 62 / 994,343, filed Mar. 25, 2020, U.S. Provisional Application No. 63 / 029,877, filed May 26, 2020, and U.S. Provisional Application No. 63 / 056,757, filed Jul. 27, 2020, the entire disclosures of which are incorporated herein by reference.

[0002] The present disclosure generally relates to the storage, processing and / or manipulation of blood and blood components, and related novel devices, systems and methods associated with such storage, processing and / or manipulation.

Background Art

[0003] It is well known to collect whole blood from a donor using manual collection procedures, such as through blood donation or a donor's visit to a blood center or hospital. In such procedures, 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 can be used to assist or facilitate the collection of blood or blood components.

[0004] 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 in 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”).

[0005] 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.

[0006] 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 advancements in various aspects of devices, systems, and methods that can be used in whole blood collection and post-collection processing systems by using continuous flow centrifugation in a system that utilizes a programmable control unit that is pre-programmed to automatically perform selected back-lab processes and can also be programmed by the user to meet the user's specific needs and requirements. [Overview of the project]

[0007] There are several embodiments of the subject matter that may be embodied separately or together in the apparatus, systems, and methods described and / or claimed herein. 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 as described in the claims appended herein or in later amended claims, or the claiming of such embodiments separately or as a set in different combinations. For the purposes of this specification and claims, unless otherwise specified, “blood” is intended to include whole blood and blood components such as concentrated red blood cells, plasma, platelets, and white blood cells, with or without anticoagulants or additives.

[0008] The following summary is intended to provide readers with a general overview of the various potential aspects of this subject matter and is non-limiting and non-exclusive with respect to various possible aspects or combinations of aspects. Additional embodiments and features may be found in the detailed description and / or accompanying drawings herein.

[0009] This disclosure provides a configurable automated blood component manufacturing system comprising durable hardware components and a disposable fluid flow circuit. The durable hardware components comprise a pump station with multiple pumps, a centrifuge mounting station and drive unit, an optical system associated with the centrifuge mounting station and drive unit, a microprocessor-based control unit including a touchscreen for receiving operator input and displaying procedure parameters, hangers for suspending containers, a weighing scale associated with each hanger configured to transmit a signal to the control unit indicating the weight of the containers supported by the associated hangers, multiple tube clamps, and a cassette nesting module including multiple valves and pressure sensors. The disposable fluid flow circuit comprises a separation chamber configured to be housed in the centrifuge mounting station and drive unit, a fluid flow control cassette configured to be mounted on the cassette nesting module, the cassette having an external tube loop that can engage with a pump so that the fluid flow through the cassette is controlled by the operation of the pump and valves, and multiple containers, each fluidly communicating with the cassette by a tube segment associated with the container, with one or more of the tube segments configured to be received by one of the tube clamps. The control unit is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by the operator via input on the touchscreen, and the control unit is further configured to be programmed by the operator to perform additional blood processing procedures.

[0010] In a second embodiment, the blood processing apparatus comprises a reusable processing apparatus and a disposable fluid flow circuit. The reusable processing apparatus includes a pump system, a valve system, a centrifuge, and a control unit. The disposable fluid flow circuit includes a processing chamber that receives the fluid through the centrifuge, a red blood cell collection container, a plasma collection container, an additive solution container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit. The control unit performs a blood priming step in which the pump system transports whole blood from the blood source to the processing chamber and transports air in the fluid flow circuit to the plasma collection container. The centrifuge separates the whole blood in the processing chamber into plasma and red blood cells. The pump system and valve system work together to transport the separated plasma and red blood cells out of the processing chamber, recombine the separated plasma and red blood cells as recombined whole blood, and perform a separation establishment step in which the recombined whole blood is transported to the processing chamber without transporting the whole blood from the blood source to the processing chamber. The pump system transports whole blood from the blood source to the processing chamber until a total of one unit of whole blood has been transported from the blood source to the processing chamber. The centrifuge separates the whole blood in the processing chamber into plasma and red blood cells. The pump system and valve system work together to transport the separated plasma from the processing chamber to the plasma collection container and the separated red blood cells from the processing chamber. A collection stage is performed in which the additive solution is carried out from the additive solution container, the separated red blood cells and the additive solution are combined as a mixture and transported to the red blood cell collection container, the pump system and valve system work together to transport air from the plasma collection container to the processing chamber, the separated red blood cells are carried out from the processing chamber, the additive solution is carried out from the additive solution container, the separated red blood cells and the additive solution are further combined as a mixture and transported to the red blood cell collection container, a red blood cell recovery stage is performed in which the pump system and valve system work together to transport the additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution is delivered to the red blood cell collection container, and an air discharge stage is performed in which the pump system and valve system work together to carry air out from the red blood cell collection container.

[0011] In another embodiment, a method is provided for processing one unit of whole blood into erythrocyte products and plasma products. This method includes performing a blood priming step in which whole blood is transported from a blood source to a processing chamber of a fluid flow circuit in order to transport air in the fluid flow circuit into a plasma collection container of the fluid flow circuit. Next, 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 to the processing chamber without transporting the whole blood from the blood source to the processing chamber. Following the separation establishment stage, whole blood is transported from the blood source to the processing room until a total of one unit of whole blood is transported from the blood source to the processing room. In the processing room, a centrifuge is operated to separate the whole blood into plasma and red blood cells. The separated plasma is transported from the processing room to a plasma collection container, the separated red blood cells are transported out of the processing room, and the additive solution is transported from the additive solution container in the fluid flow circuit. The separated red blood cells and additive solution are combined as a mixture and transported to the red blood cell collection container in the fluid flow circuit. After the collection stage, air is transported from the plasma collection container into the processing room, the separated red blood cells are transported out of the processing room, the additive solution is transported out of the additive solution container, and the separated red blood cells and additive solution are combined as a mixture and transported to the red blood cell collection container. This is followed by an additive solution flushing stage, in which the additive solution is transported from the additive solution container to the red blood cell collection container until a target amount of additive solution is delivered to the red blood cell collection container. After the additive solution flushing step, an air evacuation step is performed to remove air from the red blood cell collection container.

[0012] In yet another aspect, the blood processing device includes a pump system, a centrifuge, and a control unit. The control unit operates the pump system to transport blood from the blood source to the centrifuge, and operates the centrifuge to separate the blood in the centrifuge into plasma, red blood cells, and a buffy coat between the separated plasma and red blood cells. The control unit is then configured to operate the pump system to transport the separated plasma and red blood cells out of the centrifuge, to operate the pump system to pump air into the centrifuge, and to remove and collect the buffy coat from the centrifuge.

[0013] In another aspect, the blood processing system includes a reusable processing unit and a disposable fluid flow circuit. The processing unit includes a pump system, a centrifuge, and a control unit. The fluid flow circuit, on the other hand, includes a processing chamber that receives the blood from the centrifuge, a buffy coat collection container, and several conduits that fluidly connect the components of the fluid flow circuit. The control unit operates the pump system to transport the blood from the blood source to the processing chamber and operates the centrifuge to separate the blood in the processing chamber into plasma, red blood cells, and a buffy coat between the separated plasma and red blood cells. The control unit then operates the pump system to transport the separated plasma and red blood cells out of the processing chamber and operates the pump system to pump air into the processing chamber and transport the buffy coat from the processing chamber to the buffy coat collection container.

[0014] In yet another embodiment, a method for collecting buffy coat products involves transporting blood from a blood source to a centrifuge, where the blood is separated in the centrifuge into plasma, red blood cells, and a buffy coat between the separated plasma and red blood cells. The separated plasma and red blood cells are removed from the centrifuge, and air is introduced into the centrifuge to remove and collect the buffy coat.

[0015] In another aspect, 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. The fluid flow circuit includes a processing chamber received by the centrifuge, a red blood cell source container, a washed red blood cell container, a waste container, and several conduits that fluidly connect the components of the fluid flow circuit. The control unit is configured to perform a priming step in which the pump system and valve system work together to transport air in the fluid flow circuit to the waste container. Next, the control unit performs a washing step in which the pump system and valve system work together to transport red blood cells from the red blood cell source container to the processing chamber, and the centrifuge separates the red blood cells into supernatant and washed red blood cells. The pump system and valve system work together to transport the supernatant from the processing chamber to the waste container and the washed red blood cells from the processing chamber to the washed red blood cell container. Next, the control unit performs a red blood cell recovery step in which the pump system and valve system work together to transport air from the waste container to the processing chamber and the washed red blood cells from the processing chamber to the washed red blood cell container. Subsequently, the pump system and valve system work together to perform an air discharge step in which air is carried out from the washed red blood cell container.

[0016] In yet another aspect, a method for washing red blood cells is provided. This method includes performing a priming step in which air in a fluid flow circuit is transported to a waste container of the fluid flow circuit. Subsequently, the red blood cells are transported to a processing chamber of the fluid flow circuit, and a centrifuge performs a washing step in which the red blood cells are separated into supernatant and washed red blood cells, the supernatant is transported from the processing chamber to a waste container of the fluid flow circuit, and the washed red blood cells are transported from the processing chamber to a washed red blood cell container of the fluid flow circuit. Next, an red blood cell recovery step is performed in which air from the waste container is transported into the processing chamber and the washed red blood cells are transported from the processing chamber to the washed red blood cell container. Subsequently, an air discharge step is performed in which air is carried out from the washed red blood cell container.

[0017] These and other aspects of this subject matter are described in the following detailed description of the attached drawings. [Brief explanation of the drawing]

[0018] [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. [Figure 2] Figure 1 is a plan view of an exemplary disposable fluid flow circuit for use in combination with the durable hardware components. [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. [Figure 4] Figure 3 is a schematic diagram of a blood processing system performing the "blood priming" stage of an exemplary blood processing procedure. [Figure 5] Figure 3 is a schematic diagram of a blood processing system performing the "separation and establishment" stage of an exemplary blood processing procedure. [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. [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. [Figure 8] Figure 3 is a schematic diagram of a blood processing system performing the "red blood cell recovery" stage of an exemplary blood processing procedure, where the separated red blood cells have been reduced in white blood cells before collection. [Figure 9] This is a schematic diagram of a variation of the "red blood cell collection" stage in Figure 8, where the separated red blood cells have not been reduced in white blood cells before collection. [Figure 10] Figure 3 is a schematic diagram of a blood processing system performing the "additive solution flush" step of an exemplary blood processing procedure, in which the additive solution is guided through a leukocyte reduction filter before entering the red blood cell collection container. [Figure 11] This is a schematic diagram of a variation of the “additive solution flush” stage in Figure 10, in which the additive solution enters the red blood cell collection container without passing through the leukocyte reduction filter. [Figure 12] Figure 3 is a schematic diagram of a blood processing system performing the "air removal" step of an exemplary blood processing procedure. [Figure 13]Schematic diagram of the blood treatment system of FIG. 3 that executes the "sealing" stage of an exemplary blood treatment procedure. [Figure 14] Schematic diagram of another embodiment of a fluid flow circuit attached to the processing device of FIG. 1 to complete a blood treatment system according to one aspect of the present disclosure. [Figure 15] Schematic diagram of the blood treatment system of FIG. 14 that executes the "blood priming" stage of an exemplary blood treatment procedure. [Figure 16] Schematic diagram of the blood treatment system of FIG. 14 that executes the "separation establishment" stage of an exemplary blood treatment procedure. [Figure 17] Schematic diagram of the blood treatment system of FIG. 14 that is executing the "collection" stage of an exemplary blood treatment procedure, and the separated red blood cells are leukocyte-reduced before collection. [Figure 18] Schematic diagram of a variation of the "collection" stage of FIG. 17, where the separated red blood cells are not leukocyte-reduced before collection. [Figure 19] Schematic diagram of the blood treatment system of FIG. 14 that is executing the "red blood cell recovery" stage of an exemplary blood treatment procedure, and the recovered red blood cells are leukocyte-reduced before collection. [Figure 20] Schematic diagram of a variation of the "red blood cell recovery" stage of FIG. 19, where the recovered red blood cells are not leukocyte-reduced before collection. [Figure 21] Schematic diagram of the blood treatment system of FIG. 14 that executes the "buffy coat collection" stage of an exemplary blood treatment procedure. [Figure 22] Schematic diagram of the blood treatment system of FIG. 14 that executes the "additive solution flush" stage of an exemplary blood treatment procedure, and the additive solution is directed through a leukocyte reduction filter before entering the red blood cell collection container. [Figure 23] Schematic diagram of a variation of the "additive solution flush" stage of FIG. 22, where the additive solution enters the red blood cell collection container without passing through the leukocyte reduction filter. [Figure 24] Schematic diagram of the blood treatment system of FIG. 14 that executes the "air discharge" stage of an exemplary blood treatment procedure. [Figure 25]Figure 14 is a schematic diagram of a blood processing system performing the "sealing" stage of an exemplary blood processing procedure. [Figure 26] This is a schematic diagram of another embodiment of a fluid flow circuit attached to the processing apparatus of Figure 1 in order to complete a blood processing system according to one aspect of the present disclosure. [Figure 27] Figure 26 is a schematic diagram of a blood processing system performing the "solution priming" stage of an exemplary blood processing procedure. [Figure 28] Figure 26 is a schematic diagram of a blood processing system performing the "blood priming" stage of an exemplary blood processing procedure without red blood cell dilution. [Figure 29] This is a schematic diagram of a variation of the "blood priming" stage in Figure 28, where red blood cells are diluted using a pre-washing solution. [Figure 30] Figure 26 is a schematic diagram of a blood processing system performing the "washing" step of an exemplary blood processing procedure without red blood cell dilution. [Figure 31] This is a schematic diagram of a variation of the "washing" stage in Figure 30, in which red blood cells are diluted using a pre-washing solution. [Figure 32] This is a schematic diagram of another variation of the "washing" stage in Figure 30, where washed red blood cells are diluted with a post-washing solution. [Figure 33] Figure 26 is a schematic diagram of a blood processing system performing the "red blood cell recovery" step of an exemplary blood processing procedure without red blood cell dilution. [Figure 34] This is a schematic diagram of a variation of the "red blood cell recovery" stage in Figure 33, in which washed red blood cells are diluted with a post-washing solution. [Figure 35] Figure 26 is a schematic diagram of the blood processing system, which performs a "dilution" step in which washed red blood cells are diluted with a post-washing solution. [Figure 36] Figure 26 is a schematic diagram of a blood processing system performing the "air removal" step of an exemplary blood processing procedure. [Figure 37] Figure 26 is a schematic diagram of a blood processing system performing the "sealing" stage of an exemplary blood processing procedure. [Modes for carrying out the invention]

[0019] 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.

[0020] Figure 1 shows a reusable or durable hardware component or processing unit for a configurable, automated blood processing system or blood component manufacturing system, generally denoted by reference numeral 10, while Figure 2 shows a disposable or single-use 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.

[0021] More specifically, the illustrated processing unit 10 includes a user input and output touchscreen 14, a pump station or pump system 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 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 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 pipes or conduits, and may incorporate an RF sealer to complete the heat sealing of the pipes or conduits positioned in the clamps in order to seal the pipes or conduits leading to the product container at the completion of the procedure.

[0022] 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 at the ends of the 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.

[0023] 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.

[0024] 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.

[0025] 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, and 48. 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.

[0026] 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 may be an empty container for receiving red blood cells separated from whole blood, and container 48 may be an empty container for receiving plasma separated from whole blood. Figure 2 shows a whole blood container 44 (e.g., configured as a blood pack unit) as the 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.

[0027] 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.

[0028] 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 production of red blood cells and plasma from a single unit of whole blood (described in detail herein), buffy coat pooling and separation of the buffy coat into platelet products (described in U.S. Patent Application Publication 2018 / 0078582 incorporated herein by reference), addition of glycerol to red blood cells, red blood cell washing, platelet washing, and cryoprecipitate pooling and separation. The control unit can also perform post-processing steps.

[0029] 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.

[0030] 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.

[0031] [Collection of red blood cells and plasma products] In the exemplary procedure, the processing apparatus 10 and the fluid flow circuit 12 are used in combination to process one unit of whole blood into erythrocyte products and plasma products. 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 4-13 show different stages of the exemplary procedure. As shown in Figures 3-13, one of the clamps, clamp 24b, is not used for the production of erythrocyte and plasma products (but is used in other procedures as described herein), and other illustrated components of the processing apparatus 10 are used.

[0032] In this specification, this is referred to as the “blood priming” stage, and 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, which prime the fluid flow circuit using a separately provided fluid (e.g., anticoagulant or saline). The blood source is shown in Figure 4 as a whole blood container 44, but may instead be a living donor. Therefore, it should be understood that the term “whole blood” may refer to blood containing anticoagulant or blood without anticoagulant.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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. In such a configuration, air exiting the processing chamber 52 via the red blood cell outlet port is directed through the associated line L4 and pressure sensor 40b to line L5 and then to line L6. Valve 38a is open, and air flowing through line L14 merges with air flowing through line L3 (i.e., air exiting the processing chamber 52 via the plasma outlet port). The combined air flows through line L7, opening clamp 24c and entering the plasma collection container 48. In Figures 4-12, arrows on the containers should be understood to represent the direction of fluid flow between the container and the conduits connected to the containers. For example, line L7 is shown as being connected to the top of the plasma collection container 48, and the downward arrow (as in Figure 4) represents 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 flow of fluid exiting the whole blood container 44.

[0037] 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.

[0038] 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).

[0039] Since the blood source contains 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.

[0040] 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, the clamp 24c is closed, but the valve 38a remains open, directing the plasma from line L3 to line L6. The separated red blood cells exit the processing chamber 52 via the red blood cell outlet port and associated line L4. 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.

[0041] 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 L6 mixes with the red blood cells flowing through line L5 at the junction of the two lines L5 and L6 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 separated again into plasma and red blood cells.

[0042] 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.

[0043] 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.

[0044] 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:

[0045] Theoretical plasma pump velocity = whole blood pump velocity - ((whole blood hematocrit × whole blood pump velocity) / hematocrit of separated red blood cells) [Equation 1]

[0046] 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 at the target position, but instead tends to "flutter" around the theoretical velocity.

[0047] 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 source into the fluid flow circuit 12 until a total of one unit of whole blood has been drawn into the fluid flow circuit 12.

[0048] 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 and red blood cells. Most of the platelets in the whole blood remain in the processing chamber 52 along with some white blood cell populations (such as mononuclear cells), while larger white blood cells such as granulocytes can exit along with the packed red blood cells.

[0049] 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.

[0050] With respect to the separated red blood cells, they exit the processing chamber 52 via the red blood cell exit port and associated line L4. An additive pump 20 is operated by the control unit to draw an additive solution (in one exemplary embodiment, ADSOL®, but may be other red blood cell additives) from the additive solution container 42 via line L10. 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] Regardless of whether the collected red blood cells have undergone (or are partially undergone) leukocyte reduction, the collection phase continues until one unit of whole blood is taken 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 (from which one unit of whole blood is initially provided) 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 if 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 if 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.

[0055] Once a total of one unit of whole blood is drawn into the fluid flow circuit 12, the control unit proceeds to the “red blood cell retrieval” stage shown in Figure 8. During the red blood cell retrieval stage, air from the plasma collection container 48 (which was transported there during the blood priming stage) is used to retrieve the contents of the processing chamber 52 (which may mainly consist of red blood cells) and reduce product loss.

[0056] In the illustrated embodiment, the whole blood pump 16 is deactivated 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).

[0057] The additive pump 20 continues its operation, 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 L10. The mixture flows into line L5 and continues to flow through line L5. If the valve system is configured as shown in Figure 6 at the end of the collection stage (to guide the flow through the leukocyte reduction filter 62), then, as shown in Figure 8, valves 38a, 38b, and 38c remain closed and valve 38d is open in order to send the mixture to line L11 for leukocyte reduction. On the other hand, if the valve system is configured as shown in Figure 7 at the end of the collection stage (to bypass the leukocyte reduction filter 62), then, as shown in Figure 9, valves 38a, 38c, and 38d may remain closed and valve 38b is open in order to pass the mixture through lines L8 and L13 to bypass the leukocyte reduction filter 62. As described above regarding the collection stage, the control unit can change the configuration of the valve system from the configuration shown in Figure 8 to the configuration in Figure 9 during the red blood cell recovery stage to stop the leukocyte reduction of the mixture (for example, if the pressure of the leukocyte reduction filter 62 becomes too high).

[0058] 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 collection stage continues until all air is removed from the plasma collection container 48. In one exemplary embodiment, the weight of the plasma collection container 48 may be monitored by a weighing scale, and an empty plasma collection container 48 is detected when the weight is below a threshold. Other approaches may also be employed to determine when to terminate the red blood cell collection stage, such as using an optical sensor 34 to detect plasma flowing through line L3.

[0059] Once the red blood cell retrieval stage is complete, the procedure moves to the "additive solution flush" stage. During the additive solution flush stage, the additive solution from the additive solution container 42 is delivered into the red blood cell collection container 46 until a target amount of additive solution is present in 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 that the plasma pump is stopped to prevent the plasma from being removed from the plasma collection container 48 (although the additive pump 20 may also 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 shown in Figure 8), the additive solution flush stage proceeds as shown in Figure 10. 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 shown in Figure 9), the additive solution flush stage proceeds as shown in Figure 11. If the additive solution is pumped through the leukocyte reduction filter 62 during the additive solution flushing stage (as shown in Figure 10), the additive solution flowing through line L11 flushes the residual red blood cells in the leukocyte reduction filter 62 into the red blood cell collection container 46 (in addition to achieving an appropriate volume of additive solution for red blood cell products).

[0060] 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.

[0061] Once the additive solution flushing stage is complete, the system moves to the “air purging” stage, as shown in Figure 12. During the air purging stage, the red blood cell collection container 46 is “burped” to remove all residual air for preservation (just as air was removed from the plasma collection container 48 during the red blood cell collection stage). This is done by reversing the direction of operation of the additive pump 20, closing valve 38d (if it was not already closed at the end of the additive solution flushing stage), and opening valve 38b (if it was 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 into line L13 through the open valve 38b. The air continues through lines L8, L5, and L10, and the air ends up in the additive solution container 42. Figure 12 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).

[0062] The air removal stage continues until all air is removed from the red blood cell collection container 46, which is determined by detecting a change in the weight of the red blood cell collection container 46 (for example, using a weighing scale).

[0063] Once the air venting stage is complete, any of a number of post-processing stages can be performed. For example, Figure 13 shows a “sealed” stage in which all clamps and valves are closed and all pumps are shut down. Line L12 connected to the red blood cell collection container 46 and line L7 connected to the plasma collection container 48 are sealed and optionally cut for storage of plasma and red blood cell products. If lines L7 and L12 are cut, the plasma collection container 48 and red blood cell collection container 46 can be preserved, but the rest of the fluid flow circuit 12 is discarded. Lines L7 and L12 can be sealed (and optionally cut) according to any suitable approach, which may include, for example, sealing by RF sealers incorporated into or associated with clamps 24a and 24c. In another embodiment, the fluid flow circuit 12 may be removed from the processing apparatus 10, and lines L7 and L12 are sealed (and optionally cut) using a dedicated sealing device.

[0064] [Collection of red blood cells, plasma, and buffy coat products] As described above, by providing a plasma outlet port in the processing chamber 52, spaced apart from the blood inlet port and located downstream thereof, the interface between the separated plasma and red blood cells in the processing chamber 52 can develop into a platelet and mononuclear cell-containing layer called a buffy coat. Although the buffy coat is not collected in the procedure shown in Figures 4-13, according to variations of that procedure, the processing device 10 can be used in combination with a appropriately configured fluid flow circuit to process one unit of whole blood into separate red blood cell products, plasma products, and buffy coat products.

[0065] An exemplary fluid flow circuit is shown in Figure 14, which also shows selected components of the processing unit 10. Due to the similarity between the fluid flow circuits in Figure 3 and Figure 14, the components of the fluid flow circuit in Figure 14 that correspond to the components of the fluid flow circuit in Figure 3 described above are identified using the same reference numerals, while components of new or different configurations are identified using new reference numerals. In short, the main difference between the fluid flow circuit in Figure 3 and the fluid flow circuit in Figure 14 is that line L6 in the fluid flow circuit in Figure 3 is replaced in the fluid flow circuit in Figure 14 by a pair of lines L14 and L15, where a third line L16 merges at a joint leading from the joint to the buffy coat collection container 64. The clamp 24b of the processing unit 10 is not used in the fluid flow circuit in Figure 3, but will be associated with line L16 in the fluid flow circuit in Figure 14 and will be used during the exemplary procedure. This will be described in detail below.

[0066] Figures 15–25 show different steps of an exemplary procedure for collecting red blood cells, plasma, and buffy coat products. Many of the steps shown in Figures 15–25 are similar to the steps described above in the procedures shown in Figures 4–13. Such steps are described below with reference to the corresponding steps in the procedures in Figures 4–13. Please understand that such steps proceed according to the above descriptions of the corresponding steps in the procedures in Figures 4–13 unless otherwise specified.

[0067] The illustrated procedure, shown in Figure 4, begins with the “blood priming” stage (Figure 15), which corresponds to the blood priming stage described above, in which selected components of the fluid flow circuit are primed using blood from a blood source. As described in the explanation of the procedure in Figures 4-13 above, the blood source is shown in Figure 15 as a whole blood container 44, but a living donor may be used instead.

[0068] 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 15) via line L1 by the operation of the whole blood pump 16. The 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, and the optical sensor 34 before flowing into the processing chamber 52 located in the centrifuge 22 of the processing device 10. According to the above description of the blood priming phase in Figure 4, the centrifuge 22 may remain stationary during the blood priming phase in Figure 15 or may rotate at a low speed (e.g., about 1,000 to 2,000 rpm).

[0069] Blood entering the processing chamber 52 moves towards the high-g (radially outward) wall of the processing chamber 52, while air moves towards the low-g wall. Most of the air exits the processing chamber 52 through the plasma outlet port and associated line L3, but some air may also exit the processing chamber 52 through the red blood cell outlet port and associated line L4.

[0070] Valves 38b and 38d are closed, the plasma pump 18 is activated, and the additive pump 20 is deactivated. As a result, the air leaving the processing chamber 52 is directed through the red blood cell outlet port, through the associated line L4 and pressure sensor 40b, to line L5, and then to line L14. While valve 38a is open, clamp 24b is closed, and the air flowing through line L14 flows into line L15, and then merges with the air flowing through line L3 (i.e., the air leaving the processing chamber 52 through the plasma outlet port). The combined air flows through line L7 and the open clamp 24c and enters the plasma collection container 48. The blood priming phase continues until non-air fluid is detected in both lines L3 and L4.

[0071] The next stage (shown in Figure 16) is the "separation establishment" stage, which corresponds to the separation establishment stage shown in Figure 5 and described above. According to the above description of the established separation stage in Figure 5, 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, with a buffy coat in between (for example, in the range of about 4,500 to 5,500 rpm), and the whole blood pump 16 continues to operate (however, no additional blood is drawn from the blood source into the fluid flow circuit).

[0072] The separated plasma exits the processing chamber 52 via the plasma outlet port and associated line L3. During this stage, clamps 24b and 24c are closed, but valve 38a remains open, allowing the plasma to flow from line L3 to line L15 and then 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. As described above with respect to the procedures in Figures 4-13, there is no pump associated with line L4 (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). However, it is also within the scope of this disclosure that 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.

[0073] The additive pump 20 is inactive at this stage, thereby directing 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 L14 to form recombined whole blood. Valve 38d is closed, and the recombined whole blood is sent to line L8. Valve 38b is also closed, and the recombined whole blood is guided 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 separated again into plasma and red blood cells with a buffy coat in between.

[0074] The separation establishment phase continues, preferably with the interface between the separated plasma and separated red blood cells and the buffy coat in the processing chamber 52 at the target position, until steady-state separation is achieved. Exemplary approaches for moving the interface to the target position in the processing chamber 52 are described above in more detail with respect to the establishment phase in Figure 5.

[0075] Once steady-state separation is established, the control unit terminates the separation establishment phase and proceeds to the “collection” phase (Figure 17), which corresponds to the collection phase described above, as shown in Figure 6. 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 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 source into the fluid flow circuit until a total of one unit of whole blood has been drawn into the fluid flow circuit. As in the separation establishment phase, the buffy coat remains in the processing chamber 52 during the collection phase.

[0076] More specifically, during the collection phase, valve 38c is closed and the whole blood pump 16 draws additional blood from the blood source into line L1. The whole blood pump 16 draws the blood from the blood source from line L1 into 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.

[0077] 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.

[0078] The separated red blood cells 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 (which may be ADSOL® or some other red blood cell additive) 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 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 17 (as described above for the collection stage in Figure 6). 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 18 (as described above for the collection stage in Figure 7). It is also within the scope of this disclosure that the mixture is routed through a leukocyte reduction filter 62 at the start of the collection stage so that only a portion of the collected red blood cells are reduced in leukocytes, and that the valve system is reconfigured during the collection stage so that the mixture bypasses the leukocyte reduction filter 62.

[0079] The collection phase continues until one unit of whole blood is drawn from the blood source into the fluid flow circuit. When 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. 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 has been drawn into the fluid flow circuit.

[0080] Once a total of one unit of whole blood has been drawn into the fluid flow circuit, the control unit moves the procedure to the "red blood cell retrieval" stage, as shown in Figure 19. During the red blood cell retrieval stage, air from the plasma collection container 48 (which was delivered here during the blood priming stage) is used to retrieve any separated red blood cells remaining in the processing chamber 52 without removing the buffy coat from the processing chamber 52.

[0081] In the illustrated embodiment, the whole blood pump 16 is deactivated while the plasma pump 18 is operated in the reverse direction (with respect to its 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, thus moving the separated red blood cells in the processing chamber 52 into line 4 via the red blood cell outlet port on the high-g side. During this stage, the centrifuge 22 can 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.

[0082] The additive pump 20 continues its operation, drawing the additive solution from the additive solution container 42 through line L10 and mixing it with the red blood cells flowing through line L4 at the junction of the two lines L4 and L10. The mixture flows into line L5 and continues to flow through line L5. If the valve system is configured as shown in Figure 17 at the end of the collection stage (to guide the flow through the leukocyte reduction filter 62), valves 38a, 38b, and 38c remain closed and valve 38d is open, as shown in Figure 19, to guide the mixture to line L11 for leukocyte reduction. On the other hand, if the valve system is configured as shown in Figure 18 at the end of the collection stage (to bypass the leukocyte reduction filter 62), valves 38a, 38c, and 38d may remain closed and valve 38b is open, as shown in Figure 20, to bypass the leukocyte reduction filter 62 by passing the mixture through lines L8 and L13. As described above regarding the collection stage, the control unit can change the configuration of the valve system from the configuration shown in Figure 19 to the configuration shown in Figure 20 during the red blood cell collection stage in order to stop the leukocyte reduction of the mixture (for example, if the pressure of the leukocyte reduction filter 62 becomes too high).

[0083] Regardless of whether the mixture is filtered, it flows through the open clamp 24a into line L12 and into the red blood cell collection container 46. The red blood cell recovery stage continues until the red blood cells are removed from the processing chamber 52. This can be determined in any of a number of ways without departing from the scope of the present disclosure. In one embodiment, the red blood cell recovery stage continues until a predetermined volume of fluid (corresponding to the volume of red blood cells remaining in the processing chamber 52) is carried out of the processing chamber 52. This volume can be calculated, for example, by determining the volume of red blood cells present in one unit of whole blood (which may be determined based on the hematocrit of the blood) and then subtracting the volume of red blood cells already carried into the red blood cell collection container 46 (which may be determined based on the weight of the red blood cell container and additive solution container 42 at the end of the recovery stage). In another embodiment, the red blood cell recovery stage may continue until an optical sensor 34 detects a non-red blood cell fluid (e.g., buffy coat) flowing through line L4.

[0084] At the end of the red blood cell recovery stage in Figures 19 and 20, some air remains in the plasma collection container 48. At least some of the air remaining in the plasma collection container 48 is used in the “buffy coat collection” stage (shown in Figure 21) to transport the buffy coat in the processing chamber 52 into the buffy coat collection container 64 as a buffy coat product. Due to the air being transported through the processing chamber 52 during the buffy coat collection stage, the centrifuge 22 can continue to operate at a relatively low speed (e.g., in the range of approximately 1,000–2,000 rpm, as during the red blood cell recovery stage) to reduce the risk of air clogging.

[0085] To transition from the red blood cell retrieval stage to the buffy coat collection stage, clamp 24b is opened and clamp 24a is closed. One of valves 38b and 38d is opened at the end of the red blood cell retrieval stage, and the other is closed (depending on whether the mixture of red blood cells and additive solution is delivered through or around the leukocyte reduction filter 62). Whichever of the two valves 38b and 38d is open at the end of the red blood cell retrieval stage is closed when transitioning to the buffy coat collection stage, and both valves 38b and 38d are closed during the buffy coat collection stage. The additive pump 20 is also stopped when transitioning to the buffy coat collection stage.

[0086] With the various clamps, valves, and pumps configured as shown in Figure 21, the plasma pump 18 continues to draw air from the plasma collection container 48 into the processing chamber 52 via lines L7 and L3. Similar to the red blood cell recovery stage, the air enters the processing chamber 52 on the low-g side and moves from the low-g wall to the high-g wall as additional air is delivered to the processing chamber 52. This causes any remaining buffy coat in the processing chamber 52 to move through the red blood cell outlet port on the high-g side to line L4. The buffy coat is then directed from line L4 to line L5 and then to line L14. From line L14, the buffy coat is sent to line L16, through the open clamp 24b, and into the buffy coat collection container 64 as a buffy coat product.

[0087] The buffy coat collection step continues until the buffy coat is removed from the processing chamber 52. This can be determined in any of a number of ways without departing from the scope of the present disclosure. In one embodiment, the buffy coat collection step continues until a predetermined volume of fluid (corresponding to the volume of buffy coat or interface in the processing chamber 52) is carried out of the processing chamber 52. This volume can be calculated, for example, by subtracting the volume of plasma and red blood cells recovered at the end of the red blood cell recovery step from the volume of processed blood. In another embodiment, the buffy coat collection step may continue until the optical sensor 34 detects a non-buffy coat fluid (e.g., air) flowing through line L4.

[0088] Once the buffy coat collection stage is complete, the procedure moves to the “additive solution flush” stage (Figures 22 and 23). During the additive solution flush stage (as described above with respect to the additive solution flush stage in Figures 10 and 11), the additive solution from the additive solution container 42 is transferred to the red blood cell collection container 46 until the additive solution in the red blood cell collection container 46 reaches the target volume.

[0089] To transition from the buffy coat collection stage to the additive solution flush stage, clamp 24b is closed, clamp 24a is opened, plasma pump 18 is stopped, and additive pump 20 is restarted. Furthermore, depending on which of the two valves 38b and 38d was open at the end of the red blood cell collection stage, one of valves 38b and 38d is opened to allow the additive solution to be carried through the leukocyte reduction filter 62 (Figure 22) or around the leukocyte reduction filter 62 (Figure 23). Typically, if valve 38d was open at the end of the red blood cell collection stage (as in Figure 19), it is opened at the start of the additive solution flush stage (as in Figure 22) to allow red blood cells to be collected. This allows any red blood cells remaining in the leukocyte reduction filter 62 to be collected by the additive solution carried through the leukocyte reduction filter 62. Similarly, if valve 38b was open at the end of the red blood cell retrieval stage (as shown in Figure 20), it is opened at the start of the additive solution flush stage (as shown in Figure 23) to direct the additive solution around the leukocyte reduction filter 62. However, if the control unit determines that it is desirable to start bypassing 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 retrieval stage (as shown in Figure 19), and that valve 38b is opened and valve 38d is closed at the start of the additive solution flush stage (as shown in Figure 23). Furthermore, it is within the scope of this disclosure that the valve system is positioned as shown in Figure 22 at the start of the additive solution flush stage (to direct the additive solution towards the leukocyte reduction filter 62) and transitioned to the configuration shown in Figure 23 before the end of the additive solution flush stage (to allow the additive solution to bypass the leukocyte reduction filter 62).

[0090] The additive solution flushing phase continues until the target amount of additive solution has been added to the red blood cell collection container 46. Once the additive solution flushing phase is complete, the system moves to the “air purging” phase, as shown in Figure 24. During the air purging phase, the red blood cell collection container 46 is “burped” to remove all residual air for preservation (just as air was removed from the plasma collection container 48 during the red blood cell collection and buffy coat collection phases). 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 phase), and opening valve 38b (if it is not already open at the end of the additive solution flushing phase). The additive pump 20 draws air from the red blood cell collection container 46 to the additive solution container 42, as described above for the air purging phase in Figure 12. Figure 24 shows the air being purged 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.

[0091] The air removal stage continues until all air is removed from the red blood cell collection container 46. Once the air removal stage is complete, any of several post-processing stages can be performed. For example, Figure 25 shows the “sealing” stage, in which all clamps and valves are closed and all pumps are stopped. Line L12 connected to the red blood cell collection container 46, line L7 connected to the plasma collection container 48, and line L16 connected to the buffy coat collection container 64 are sealed and cut as needed for the storage of plasma, red blood cells, and buffy coat products. Although it is possible to remove air from the buffy coat collection container 64 before sealing line L16 (for example, using a variation of the air removal stage in Figure 24), this is usually not necessary, as it is most common for the collected buffy coat to be pooled together with other buffy coats. The pooled buffy coat is processed to produce platelet products.

[0092] [Washing of red blood cell products] One possible post-transfusion step is the "washing" of red blood cell products. Red blood cells are often stored for extended periods before transfusion. In this case, the cells are usually "washed" before transfusion to remove the supernatant suspension (and therefore undesirable extracellular material) from the cells while maintaining cellular integrity and functionality, thereby reducing the likelihood of an immune response in the recipient.

[0093] Figure 26 shows an exemplary fluid flow circuit for washing red blood cell products (along with selected components of the processing apparatus 10). Figures 27–37 show different stages of an exemplary red blood cell washing procedure. It should be understood that the fluid flow circuit and the procedures in Figures 26–37 are illustrative only, and the fluid flow circuit and procedures for washing red blood cells can be configured in different ways without departing from the scope of this disclosure. It should also be understood that this method may be performed using pre-set parameters, or it may be configurable to allow the user to customize their own washing protocol. The procedure described herein exemplifies a standard, pre-set washing process.

[0094] The fluid flow circuit in Figure 26 includes an erythrocyte source container 66. In one embodiment, a sealed erythrocyte collection container 46 obtained using one of the procedures described herein can be connected to another fluid flow circuit to provide a source container 66. In another embodiment, erythrocytes can exit the erythrocyte collection container 46 and be transported into the erythrocyte source container 66 of a separate fluid flow circuit. However, it should be understood that the washing procedure described herein is not limited to erythrocytes obtained according to one of the procedures described herein, and the erythrocytes to be washed can be obtained in a variety of ways without departing from the scope of this disclosure.

[0095] The illustrated procedure begins with a priming stage in which the fluid flow circuit is primed using either a washing solution (Figure 27) or stored red blood cells (Figures 28 and 29). The stage in Figure 27 is referred to herein as the “solution priming” stage. This is an optional stage, and the system can function without solution priming, instead by priming the fluid flow circuit using only red blood cells from the red blood cell source container 66, as described below (and shown in Figures 28 and 29). The application of the solution priming stage may depend on any of many factors, including user preference, the quality of the red blood cell product, the type of solution used, and the specific configuration of the fluid flow circuit. Before starting the procedure, the operator may be presented with the choice of performing the initial solution priming stage or starting by priming the fluid flow circuit using stored red blood cells instead.

[0096] The illustrated fluid flow circuit includes two solution containers 68 and 70, the solutions stored in the two containers 68 and 70 being the same or different (the solutions are collectively referred to herein as “washing solutions” and the containers as “washing solution containers”). In the procedures described herein, the two washing solutions are different and used at different stages of the procedure. When the solution priming stage is performed, the solution stored in washing solution container 68 (this solution is collectively referred to herein as “pre-washing solution” and this container as “pre-washing solution container”) is used to dilute the red blood cells for washing (described below) and to prime the fluid flow circuit. In exemplary embodiments, the pre-washing solution may be saline solution, but it should be understood that other fluids can be used as pre-washing solutions without departing from the scope of this disclosure. The liquid stored in washing solution container 70 (the solution is collectively referred to herein as “post-washing solution” and the container as “post-washing solution container”) can ultimately be used to dilute or store the washed red blood cell product. In exemplary embodiments, the post-wash solution may be ADSOL®, but it should be understood that other fluids (e.g., some other red blood cell additive solution) can be used as the post-wash solution without departing from the scope of this disclosure.

[0097] If a solution priming stage is required, valve 38b is opened and the pre-wash solution is drawn from the pre-wash solution container 68 into line L17 by pump 20 (referred to as the "wash solution pump" in this procedure). Clamp 24a is closed and the pre-wash solution is sent to line L18. Valve 38d is closed and valve 38c is opened, allowing the pre-wash solution to flow from line L18 to line L19 and then to the confluence of lines L19, L20, and L21.

[0098] Pump 16 (referred to as the “source pump” in this description of the procedure) and pump 18 (referred to as the “waste pump” in this description of the procedure) are both operating during the solution priming phase. Portions of the prewash solution are sent from line L19 to lines L20 and L21. A portion of the prewash solution directed to line L20 flows through the air trap 60 and pressure sensor 40c to the red blood cell source container 66, while a portion of the prewash solution directed to line L21 enters the processing chamber 52 (located within the centrifuge 22 of the processing unit 10) through the pressure sensor 40a and optical sensor 34. The percentage of prewash solution sent to lines L20 and L21 depends on the relative speeds of pumps 16 and 18. Typically, the waste pump 18 is operated at a faster speed than the source pump 18, directing more prewash solution to line L21 than to L20. This can be advantageous because it tends to remove more air from the passages through which the prewash solution flowing into line L21 passes.

[0099] As in the blood priming stage described above, the centrifuge 22 may remain stationary during the solution priming stage, 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). As explained above, it may be advantageous for the centrifuge 22 to rotate during the blood priming stage 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 L17, L18, L19, and / or L21 by the flow of the pre-wash solution) is forced toward the low g-wall of the processing chamber 52. However, as also explained above, higher centrifuge rotational speeds may be undesirable because air blocks are more likely to occur with higher g-forces.

[0100] The pre-wash solution entering the processing chamber 52 moves towards the high-g wall of the processing chamber 52, and the air moves towards the low-g wall. The supernatant outlet port of the processing chamber 52 (corresponding to the outlet port called the "plasma outlet port" in the description of the procedure above) is associated with the low-g wall of the processing chamber 52, and most of the air exits the processing chamber 52 through the supernatant outlet port and associated line L22, although some air may also exit the processing chamber 52 through the red blood cell outlet port associated with the high-g wall of the processing chamber 52.

[0101] Valve 38a is open and clamp 24b is closed, directing air exiting the processing chamber 52 via the red blood cell outlet port to the junction with the associated lines L23, L24, and L22. At the junction, the air flowing through line L24 merges with the air flowing through line L22 (i.e., the air exiting the processing chamber 52 via the supernatant outlet port). The combined air flows through line L25 and the open clamp 24c into the waste container 72.

[0102] The airflow exiting the processing chamber 52 through either outlet port 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 L22 and L23. When non-air fluid is detected in both lines L22 and L23, and when it is detected that a portion of the pre-wash solution directed to line L20 has reached the red blood cell source container 66 (for example, by a slight increase in weight measured by an associated weighing scale), the control unit of the processing apparatus 10 terminates the solution priming phase and moves to the next stage of the procedure. If a portion of the fluid flow circuit is primed before other portions, the pumps 16, 18 associated with the primed portion of the fluid flow circuit may be stopped until the end of the solution priming phase.

[0103] Figures 28 and 29 show two variations of the “blood priming” stage. The illustrated stage is called the “blood priming” stage, but it can be seen that the fluid flow circuit is primed using erythrocyte products rather than whole blood. In the variation in Figure 28, the fluid flow circuit is primed using erythrocyte products without adding prewash solution to the erythrocyte products upstream of the processing chamber 52, whereas Figure 29 illustrates a variation in which the fluid flow circuit is primed using erythrocyte products, and prewash solution is added to the erythrocyte products upstream of the processing chamber 52, which tends to dilute the supernatant and improve the washout rate. The variation in Figure 28 is advantageous when the objective of the procedure is simply to reduce the volume of the product, while the variation in Figure 29 is advantageous when the objective of the procedure is to wash away contaminants. Before commencing the procedure, the operator may be presented with the option to dilute the erythrocyte products in the blood priming stage.

[0104] In both variations, red blood cells are drawn from the red blood cell source container 66 to the fluid flow circuit via line L20 by the operation of the source pump 16. The red blood cells pass through the pressure sensor 40c and air trap 60 before reaching the junction of lines L19, L20, and L21. In the embodiment of Figure 28, valve 38c is closed, thereby guiding the red blood cells to line L21, through the pressure sensor 40a and optical sensor 34, into the processing chamber 52. In the embodiment of Figure 29, valve 38c is open along with valve 38b, and clamp 24a and valve 38d are closed. The washing solution pump 20 is operated to draw the pre-wash solution from the pre-wash solution container 68 via line L17, through lines L18 and L19, to the junction of lines L19, L20, and L21, where the pre-wash solution is mixed with the red blood cells being pumped via line L20. The diluted red blood cells flow into the processing chamber 52 via line L21, pressure sensor 40a, and optical sensor 34.

[0105] The rotational speed of the centrifuge 22 may depend on whether a solution priming phase has been performed. If a solution priming phase has not been performed, the centrifuge 22 may remain stationary during the blood priming phase, or it may be controlled by the control unit of the processing unit 10 to rotate at a low rotational speed (e.g., about 1,000-2,000 rpm), which is advantageous for the reasons mentioned above. On the other hand, if a solution priming phase has been performed, the centrifuge 22 may be controlled to operate at a higher rotational speed (e.g., about 4,500-5,000 rpm), which may be equal to the rotational speed during the subsequent "washing" phase (described in more detail). As explained above, performing a solution priming phase first reduces the risk because the red blood cells flowing into the processing chamber 52 replace the washing solution rather than the air, but increasing the rotational speed when priming the fluid flow circuit is not desirable because it increases the likelihood of air blockage.

[0106] Red blood cells (diluted or undiluted) entering the processing chamber 52 move toward the high g wall of the processing chamber 52, moving air (if the blood priming phase is the initial phase) or washing solution (if the blood priming phase follows the solution priming phase) toward the low g wall. Most of the air (or washing solution) exits the processing chamber 52 through the supernatant outlet port and associated line L22, although some air (or washing solution) may also exit the processing chamber 52 through the red blood cell outlet port and associated line L23. Valve 38a is open, but clamp 24b is closed. This directs the air (or washing solution) exiting the processing chamber 52 through the red blood cell outlet port through associated line L23, through line L24, and to the junction with line L22. At the junction, the air (or washing solution) flowing through line L24 merges with the air (or washing solution) flowing through line L22 (i.e., the air or washing solution exiting the processing chamber 52 through the supernatant outlet port). The combined air (or cleaning solution) flows through line L25 and the open clamp 24c into the waste container 72. The fluid flow exiting the processing chamber 52 through the outlet port is monitored by an optical sensor 34 to determine when to terminate the blood priming phase.

[0107] After the fluid flow circuit is primed, the procedure proceeds to the “washing” stage, in which the red blood cells are centrifuged and the supernatant suspension is removed from the cells. The centrifuge 22 is operated at a speed sufficient to separate the red blood cell product into washed red blood cells and supernatant, and this speed may be in the range of, for example, about 4,500 to 5,500 rpm. As mentioned above, if the solution priming stage is omitted, the centrifuge 22 may be operating at a relatively low rotational speed during the blood priming stage, in which case the rotational speed of the centrifuge 22 will increase when transitioning to the washing stage. Also as mentioned above, if the solution priming stage is performed, the centrifuge 22 may be operating at a relatively high rotational speed during the blood priming stage, in which case the rotational speed of the centrifuge 22 may remain the same when transitioning to the washing stage.

[0108] Figures 30-32 show three variations of the washing step; Figure 30 shows an embodiment in which the red blood cells are not diluted; Figure 31 shows an embodiment in which the washing solution is added to the red blood cells upstream of the processing chamber 52 (to dilute the supernatant and improve the washout rate); and Figure 32 shows an embodiment in which the washed red blood cells are mixed with the washing solution after leaving the processing chamber 52 (to "volume up" the washed red blood cells). The variation of Figure 30 is advantageous if the objective of the procedure is simply to reduce the volume of the product; the variation of Figure 31 is advantageous if the objective of the procedure is to wash away contaminants; the variation of Figure 32 may be advantageous if additional storage is required. The variation in Figure 32 can be used in combination with one of the other variations, which may include starting the washing phase with the variation in Figure 30 before moving to the variation in Figure 32 (to initiate the "volume-up" of the washed red blood cells), or rapidly switching between the variations in Figure 31 and Figure 32 throughout the washing phase (to dilute the supernatant and initiate the "volume-up" of the washed red blood cells).

[0109] The procedure most typically involves a transition from a specific blood priming stage to a specific washing stage, but it can also transition from any variation of the blood priming stage to any variation of the washing stage. For example, if the red blood cells are not diluted during the blood priming stage (as in Figure 28), it is most typical to transition to a washing stage where the red blood cells are not diluted upstream of the processing chamber 52 (e.g., as in Figure 30 or Figure 32). Similarly, if the red blood cells are diluted during the blood priming stage (as in Figure 29), it is most typical for the upstream dilution to continue during the washing stage (as in Figure 31). Before initiating the procedure, the operator may be given a choice of which variation of the washing stage to adopt, which may include the variation in Figure 32 and one combination of the variations in Figures 30 and 31. In another embodiment, the control unit may determine which variation of the blood priming and washing stages to adopt based on input provided by the operator and execute the procedure accordingly, or provide recommendations to the operator based on the input.

[0110] In the embodiment shown in Figure 30, red blood cells are drawn from the red blood cell source container 66 into the fluid flow circuit via line L20 by the operation of the supply source pump 16. The red blood cells pass through the pressure sensor 40c and air trap 60 before reaching the junction of lines L19, L20, and L21. The valve 38c is closed, guiding the red blood cells into line L21, passing through the pressure sensor 40a and optical sensor 34, and then into the processing chamber 52.

[0111] In the processing chamber 52, the supernatant suspension is separated from the red blood cells. In one embodiment, the optical system described above, including the laser 30 and the photodetector 32 (Figure 1), can be used to locate and control the position of the interface between the supernatant suspension and the red blood cells in the centrifuge 22. Alternatively, a system with a different configuration can be used to monitor the separation process and ensure that it is proceeding as desired. For example, the optical sensor 34 can monitor the outlet lines L22 and L23 to ensure that the separated fluid components are exiting the processing chamber 52 through the appropriate outlets.

[0112] The supernatant suspension exits the processing chamber 52 via the supernatant outlet port (and associated line L22), while the washed red blood cells exit the processing chamber 52 via the red blood cell outlet port (and associated line L23). Valves 38a and 38d are closed, and clamps 24b and 24c are opened, allowing the supernatant to be directed to the waste container 72 (via lines L22 and L25) and the washed red blood cells to be directed to the washed red blood cell container 74 (via lines L23, L26, and L27). There is no pump associated with line L23 so that the washed red blood cells exit the processing chamber 52 at a rate equal to the difference between the rate of the source pump 16 and the rate of the waste pump 18. In alternative embodiments, there may be a pump associated with the red blood cell outlet line instead of the supernatant outlet line, or a first pump associated with the supernatant outlet line and a second pump associated with the red blood cell outlet line.

[0113] The change in Figure 31 begins similarly to the change in Figure 30, with red blood cells being drawn into the junctions of lines L19, L20, and L21 by the operation of the source pump 16. Valve 38c is not closed (as in Figure 30), but is open along with valve 38b, with clamp 24a and valve 38d closed. The wash solution pump 20 operates to draw the pre-wash solution from the pre-wash solution container 68 through line L17, through lines L18 and L19, to the junction of lines L19, L20, and L21, where the pre-wash solution is mixed with the red blood cells being pumped through line L20. The diluted red blood cells flow into the processing chamber 52 via line L21, pressure sensor 40a, and optical sensor 34.

[0114] As shown in the embodiment of Figure 30, the supernatant suspension is separated from the red blood cells in the processing chamber 52, the supernatant suspension (including the pre-wash solution) is discharged from the processing chamber 52 via the supernatant outlet port (and associated line L22), and the washed red blood cells exit the processing chamber 52 via the red blood cell outlet port (and associated line L23). Valve 38a is closed and clamps 24b and 24c are opened, and the supernatant is led (via lines L22 and L25) to the waste container 72 and the washed red blood cells are led (via lines L23, L26, and L27) to the washed red blood cell container 74.

[0115] The modification in Figure 32 begins similarly to the modification in Figure 30, with red blood cells being drawn from the red blood cell source container 66 to the processing chamber 52, where the supernatant suspension is separated from the red blood cells and directed to the waste container 72. As in Figure 30, the washed red blood cells exit the processing chamber 52 through the red blood cell outlet port and flow through the associated line L23 to line L26. Unlike the embodiment in Figure 30, valve 38d is open along with clamp 24a. Valves 38b and 38c are closed, and the washing solution pump 20 is activated to draw the post-washing solution from the post-washing solution container 70 through line L28, through lines L18 and L29, to the confluence of lines L26 and L29. At the confluence, the post-washing solution is mixed with the washed red blood cells flowing through line L26, and the mixture flows into line L27 and into the washed red blood cell container 74. Figures 31 and 32 show different washing solutions used before and after washing red blood cells, but it should be understood that the same washing solution can be used as both a pre-wash and a post-wash solution.

[0116] Regardless of which variation of the washing phase is performed, the washing phase ends when the red blood cell source container 66 is empty, and different approaches may be used to determine when the red blood cell source container 66 is empty. For example, in one embodiment, a pressure sensor 40c monitors the hydrostatic pressure of the red blood cell source container 66. An empty red blood cell source container 66 may be detected when the hydrostatic pressure measured by the pressure sensor 40c is below a threshold. Alternatively (or additionally), the weight of the red blood cell source container 66 may be monitored by a weighing scale, and an empty red blood cell source container 66 may be detected when the weight is below a threshold.

[0117] Once the red blood cell source container 66 is empty, the procedure moves to the “red blood cell recovery” stage, in which the washed red blood cells are recovered from the processing chamber 52 using air from the waste container 72 (which was transported there during the priming stage). Figures 33 and 34 show two variations of the red blood cell recovery stage, with Figure 33 showing an embodiment in which the red blood cells in the processing chamber 52 are poured into the washed red blood cell container 74 without further dilution, and Figure 34 showing an embodiment that includes further dilution of the washed red blood cells using a washing solution.

[0118] The procedure may most typically involve a transition from a specific washing stage to a specific red blood cell recovery stage, but it can also transition from any variation of the washing stage to any variation of the red blood cell recovery stage. For example, if the washed red blood cells are not diluted at the end of the washing stage (as in Figures 30 and 31), it may most typically be that the washed red blood cells transition to the red blood cell recovery stage without being diluted downstream of the processing chamber 52 (as in Figure 33). Similarly, if the washed red blood cells are diluted at the end of the washing stage (as in Figure 32), it may most typically be that the downstream dilution continues in the red blood cell recovery stage (as in Figure 34). Before starting the procedure, the operator may choose which variation of the red blood cell recovery stage to adopt. This may include a combination of two variations (for example, a transition from the variation in Figure 34 to the variation in Figure 33 after sufficient washing solution has been delivered to the washed red blood cell container 74). In another embodiment, the control unit can determine which variation of the red blood cell recovery step to adopt based on input provided by the operator and execute the procedure accordingly, or provide recommendations to the operator based on the input.

[0119] In both variations, the source pump 16 is stopped and the waste pump 18 is operated in the reverse direction (with respect to its direction of operation up to this stage of the procedure). This draws air from the waste container 72 into line L25. Valve 38a remains closed, directing the air to the processing chamber 52 through line L25, line L22, and the supernatant outlet port. As the air flows through the supernatant 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, through line L23, and to line L26. During this stage, the centrifuge 22 can be operated at a slower speed (e.g., in the range of about 1,000-2,000 rpm) to reduce the risk of air blockage (as during the priming stage).

[0120] In the modified version of Figure 33, valve 38d is closed and clamp 24b is open, guiding the recovered red blood cells into line L27 and through line L27 into the washed red blood cell container 74. In the modified version of Figure 34, valve 38d is open along with clamp 24a, and valves 38c and 38d are closed. The washing solution pump 20 operates to draw the post-washing solution from the post-washing solution container 70 through line L28, through lines L18 and L29, to the confluence of lines L26 and L29. At the confluence, the post-washing solution mixes with the recovered red blood cells flowing through line L26, and the mixture flows into line L27 and into the washed red blood cell container 74. Figure 34 shows washed red blood cells diluted with a different washing solution than the one (optionally) used to prime the fluid flow circuit, but it should be understood that the same washing solution may be used for both.

[0121] The red blood cell retrieval step may continue until the optical sensor 34 detects air leaving the red blood cell exit port, until all air is removed from the waste container 72 (for example, as determined by a weighing scale associated with the waste container 72), or until a predetermined volume has moved. Other approaches may also be used to determine when to terminate the red blood cell retrieval step without departing from the scope of this disclosure.

[0122] An optional “dilution” step follows the red blood cell retrieval step. During the dilution step, washing solution is added to the washed red blood cells in the washed red blood cell container 74 until the target volume of washing solution is added to the washed red blood cell container 74. If sufficient washing solution has already been added during the washing and / or red blood cell retrieval steps, the dilution step may not be necessary. On the other hand, if additional dilution is required (most typically when the washing solution pump 20 was used in the early stages of the procedure to dilute the supernatant before the red blood cells enter the processing chamber 52), the dilution step may be necessary. Figure 35 shows an exemplary dilution step in which washed red blood cells are diluted with a washing solution different from the one used to prime the fluid flow circuit (optionally), but it should be understood that the same washing solution may be used for both, or that washing solutions from both washing solution containers 68 and 70 may be used.

[0123] In the embodiment of Figure 35, valves 38b and 38c remain closed, and clamps 24a and valve 38d are open (if not already open during the red blood cell recovery stage). Clamp 24b remains open, and clamp 24c is closed. The waste pump 18 is stopped (if not already operated during the red blood cell recovery stage) to draw the post-wash solution from the post-wash solution container 70 through line L28, and through lines L18, L29, and L27 to the washed red blood cell container 74, while the wash solution pump 20 is activated (if not already operated during the red blood cell recovery stage). This may continue until a predetermined volume of wash solution has been transferred, which can be detected by a weighing scale associated with one of the wash solution containers used during the dilution stage.

[0124] Once the dilution stage is complete, the system moves to the “air purging” stage, as shown in Figure 36. During the air purging stage, the washed red blood cell container 74 is “burped” to remove all residual air for storage. This is done by reversing the direction of operation of the washing solution pump 20, which causes the washing solution pump 20 to draw air from the washed red blood cell container 74 through line L27 and open clamp 24b, passing through line L29 and open valve 38d. The air continues through line L18, line L28, and open clamp 24a, and the air ends up in the post-wash solution container 70. Although Figure 36 shows the air being purged from the washed red blood cell container 74 to the post-wash solution container 70, 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 (e.g., pre-wash solution container 68 and / or waste container 72, if any).

[0125] The air removal stage continues until all air has been removed from the washed red blood cell container 74, which is determined by detecting the change in weight of the washed red blood cell container 74 (for example, by using a weighing scale).

[0126] Once the air discharge stage is complete, any of a number of post-processing stages can be performed. For example, Figure 37 shows the “sealed” stage, where all clamps and valves are closed and all pumps are stopped. Line L27, connected to the washed red blood cell collection container 74, is sealed to store the washed red blood cells and cut as necessary. If line L27 is cut, the washed red blood cell container 74 can be stored and the remainder of the fluid flow circuit is discarded. Line L27 can be sealed (and optionally cut) according to any suitable approach, which may include, for example, sealing by an integrated or associated RF sealer. In another embodiment, line L27 can be sealed (and optionally cut) using a dedicated sealing device to remove the fluid flow circuit from the processing unit 10.

[0127] [Pattern] Embodiment 1 The blood processing apparatus comprises a reusable processing apparatus and a disposable fluid flow circuit. The reusable processing apparatus includes a pump system, a valve system, a centrifuge, and a control unit. The disposable fluid flow circuit includes a processing chamber that receives the fluid through the centrifuge, a red blood cell collection container, a plasma collection container, an additive solution container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit. The control unit performs a blood priming step in which the pump system transports whole blood from the blood source to the processing chamber and transports air in the fluid flow circuit to the plasma collection container. The centrifuge separates the whole blood in the processing chamber into plasma and red blood cells. The pump system and valve system work together to transport the separated plasma and red blood cells out of the processing chamber, recombine the separated plasma and red blood cells as recombined whole blood, and perform a separation establishment step in which the recombined whole blood is transported to the processing chamber without transporting the whole blood from the blood source to the processing chamber. The pump system transports whole blood from the blood source to the processing chamber until a total of one unit of whole blood has been transported from the blood source to the processing chamber. The centrifuge separates the whole blood in the processing chamber into plasma and red blood cells. The pump system and valve system work together to transport the separated plasma from the processing chamber to the plasma collection container and the separated red blood cells from the processing chamber. A collection stage is performed in which the additive solution is carried out from the additive solution container, the separated red blood cells and the additive solution are combined as a mixture and transported to the red blood cell collection container, the pump system and valve system work together to transport air from the plasma collection container to the processing chamber, the separated red blood cells are carried out from the processing chamber, the additive solution is carried out from the additive solution container, the separated red blood cells and the additive solution are further combined as a mixture and transported to the red blood cell collection container, a red blood cell recovery stage is performed in which the pump system and valve system work together to transport the additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution is delivered to the red blood cell collection container, and an air discharge stage is performed in which the pump system and valve system work together to carry air out from the red blood cell collection container.

[0128] Embodiment 2: The blood processing system of Embodiment 1, wherein the fluid flow circuit includes a whole blood container for containing one unit of whole blood, and the blood volume is the whole blood container.

[0129] Embodiment 3: A 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.

[0130] Embodiment 4 A blood processing system according to any one of Embodiments 2 to 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 based at least partially on the weight of the whole blood container.

[0131] Embodiment 5: The blood processing system of Embodiment 1, wherein the blood source is a living donor.

[0132] Embodiment 6: A blood processing system according to any one of the above embodiments, wherein the processing chamber is formed of a rigid material overall.

[0133] Embodiment 7 A blood processing system according to any one of Embodiments 1 to 5, wherein the processing chamber is formed entirely from a flexible material.

[0134] Embodiment 8 A blood processing system according to any one of the above embodiments, wherein the processing apparatus includes an optical sensor configured to monitor the fluid leaving the processing chamber, and the control unit is configured to terminate the blood priming stage when the optical sensor detects a non-air fluid leaving the processing chamber.

[0135] Embodiment 9: A blood processing system according to any one of the above embodiments, wherein the control unit is configured to control the centrifuge to maintain a static state during the blood priming stage.

[0136] Embodiment 10 A blood processing system according to any one of Embodiments 1 to 8, wherein the control unit is configured to control the centrifuge to rotate during the blood priming stage.

[0137] Embodiment 11 A blood processing system according to any one embodiment of the above, wherein the processing apparatus includes an interface detector configured to determine the position of the interface 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 when the control unit determines that steady-state separation has been achieved.

[0138] Embodiment 12 A blood processing system in any one of the above embodiments, wherein the processing device includes a leukocyte reduction filter, and a pump system and a valve system cooperate to transport the mixture through the leukocyte reduction filter before it is transported to a red blood cell collection container, for at least part of the collection stage.

[0139] Embodiment 13 A blood processing system according to Embodiment 12, wherein the processing apparatus 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 the mixture to a red blood cell collection container without first passing through the leukocyte reduction filter, at least in part based on the pressure of the leukocyte reduction filter.

[0140] Embodiment 14 The blood processing system of Embodiment 13, wherein the control unit is configured to control the valve system so that the mixture is guided through the leukocyte reduction filter at the start of the red blood cell recovery phase if the mixture is guided through the leukocyte reduction filter at the end of the collection phase, and is configured to control the valve system so that the mixture is guided to the red blood cell recovery container without first passing through the leukocyte reduction filter during the red blood cell recovery phase if the mixture is guided to the red blood cell recovery container without first passing through the leukocyte reduction filter at the end of the collection phase.

[0141] Embodiment 15 A blood processing system of any one of the preceding embodiments, wherein the control unit is configured to control the centrifuge to operate at a slower rate during the red blood cell recovery phase than during the collection phase.

[0142] Embodiment 16 A blood processing system according to any one of the preceding embodiments, wherein the processing device includes a second weighing scale configured to measure the weight of a plasma collection container, and the control unit is configured to terminate the red blood cell recovery step at least in part based on the weight of the plasma collection container.

[0143] Embodiment 17 A blood processing system according to any one of the preceding embodiments, wherein the processing apparatus includes a third weighing scale configured to measure the weight of an additive solution container, and the control unit is configured to terminate the additive solution flushing step at least in part based on the weight of the additive solution container.

[0144] Embodiment 18 A blood processing system according to any one of the preceding embodiments, wherein the processing apparatus includes a fourth weighing scale configured to measure the weight of a red blood cell collection container, and the control unit is configured to terminate the additive solution flushing step at least in part based on the weight of the red blood cell collection container.

[0145] Embodiment 19 A blood processing system according to any one of the preceding embodiments, wherein the processing device includes a fourth weighing scale configured to measure the weight of a red blood cell collection container, and the control unit is configured to terminate the air evacuation step at least in part based on the weight of the red blood cell collection container.

[0146] Embodiment 20 A blood processing system according to any one of the preceding embodiments, wherein the processing apparatus includes a sealing system, and the control unit is configured to control the sealing system to seal a first conduit connected to a red blood cell collection container and a second conduit connected to a plasma collection container at the end of the air discharge step.

[0147] Embodiment 21 A blood processing system of any one of the preceding embodiments, wherein the fluid flow circuit includes a buffy coat collection container, and between the separation establishment step and the collection step, whole blood is separated in the processing chamber into plasma, red blood cells and a buffy coat between the separated plasma and separated red blood cells, and the control unit is configured to perform a buffy coat collection step in which a pump system and a valve system cooperate to transport air from the plasma collection container to the processing chamber in order to carry the buffy coat out of the processing chamber and into the buffy coat collection container after the completion of the red blood cell recovery step and before performing the additive solution flush step.

[0148] Embodiment 22 A blood processing system according to Embodiment 21, wherein the processing apparatus includes an optical sensor configured to monitor the fluid leaving the processing chamber, and the control unit is configured to terminate the red blood cell recovery step when the optical sensor detects a non-red blood cell fluid leaving the processing chamber.

[0149] Embodiment 23 A blood processing system according to any one of Embodiments 21 to 22, wherein the processing apparatus includes an optical sensor configured to monitor the fluid leaving the processing chamber, and the control unit is configured to terminate the buffycoat collection step when the optical sensor detects a non-buffycoat fluid leaving the processing chamber.

[0150] Embodiment 24 A blood processing system in any one of Embodiments 21 to 23, wherein the processing apparatus includes a sealing system, and the control unit is configured to control the sealing system to seal a conduit connected to a buffy coat collection container at the end of the air discharge step.

[0151] Embodiment 25 A method for processing one unit of whole blood into red blood cell products and plasma products, wherein a blood priming step is performed in which whole blood is transported from a blood source to a processing chamber of a fluid flow circuit in order to transport air in the fluid flow circuit into a plasma collection container of the fluid flow circuit, a centrifuge is operated to separate the whole blood in the processing chamber into plasma and red blood cells, the separated plasma and red blood cells are transported out of the processing chamber and recombined as recombined whole blood, the recombined whole blood is transported to the processing chamber without transporting the whole blood from the blood source to the processing chamber, whole blood is transported from the blood source to the processing chamber until a total of one unit of 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 and red blood cells, the separated plasma is transported from the processing chamber to a plasma collection container, and the separated A method comprising: carrying red blood cells out of the processing chamber, carrying out the additive solution from the additive solution container of the fluid flow circuit, performing a collection step in which the separated red blood cells and additive solution are combined as a mixture and carried to a red blood cell collection container of the fluid flow circuit; carrying out a red blood cell recovery step in which air from the plasma collection container is carried into the processing chamber, carrying out the separated red blood cells out of the processing chamber, carrying out the additive solution from the additive solution container, carrying out the separated red blood cells and additive solution as a mixture and carried to a red blood cell collection container; performing an additive solution flush step in which the additive solution is carried from the additive solution container to the red blood cell collection container until a target amount of additive solution is carried to the red blood cell collection container; and performing an air discharge step in which air is discharged from the red blood cell collection container.

[0152] Embodiment 26 The method of Embodiment 25, wherein the fluid flow circuit includes a whole blood container for containing one unit of whole blood, and the blood source is the whole blood container.

[0153] Embodiment 27 The method of Embodiment 26, wherein performing the collection step includes measuring the hydrostatic pressure of the whole blood container, and the collection step is terminated at least in part based on the hydrostatic pressure of the whole blood container.

[0154] Embodiment 28 The method according to any one of Embodiments 26 to 27, wherein the collection step comprises measuring the weight of the whole blood container and terminating the collection step based at least in part on the weight of the whole blood container.

[0155] Embodiment 29: The method of Embodiment 25, wherein the blood source is a living donor.

[0156] Embodiment 30 The processing chamber is formed of a rigid material overall, according to any one of Embodiments 25 to 29.

[0157] Embodiment 31 The processing chamber is formed entirely of a flexible material, according to any one of Embodiments 25 to 29.

[0158] Embodiment 32 A method of any one of Embodiments 25 to 31, wherein performing the blood priming stage includes monitoring the fluid leaving the processing chamber, and terminating the blood priming stage when it is detected that a non-air fluid has left the processing chamber.

[0159] Embodiment 33 The method of any one of Embodiments 25 to 32, wherein the centrifuge remains stationary during the blood priming stage.

[0160] Embodiment 34 The centrifuge is rotated during the blood priming stage, according to any one of Embodiments 25 to 32.

[0161] Embodiment 35 A method of any one of Embodiments 25 to 34, wherein performing the separation establishment step includes determining the location of the interface between separated blood components in the processing chamber, and terminating the separation establishment step if it is determined that the interface is in the target location and steady-state separation has been achieved.

[0162] Embodiment 36 The method according to any one of Embodiments 25 to 35, wherein the execution of the collection step includes transporting the mixture through a leukocyte reduction filter for at least part of the collection step before the mixture is transported to a red blood cell collection container.

[0163] Embodiment 37 The method of Embodiment 36, wherein performing the collection step comprises measuring the pressure of the leukocyte reduction filter and directing the mixture to a red blood cell collection container without first passing through the leukocyte reduction filter, at least in part based on the pressure of the leukocyte reduction filter.

[0164] Embodiment 38 The method of Embodiment 37, wherein the execution of the red blood cell recovery step is such that the mixture is led through a leukocyte reduction filter at the beginning of the red blood cell recovery step if the mixture is led through a leukocyte reduction filter at the end of the red blood cell recovery step, and the mixture is led to the red blood cell container without first passing through a leukocyte reduction filter at the end of the red blood cell recovery step, and the mixture is led to the red blood cell container without first passing through a leukocyte reduction filter during the red blood cell recovery step.

[0165] Embodiment 39 The execution of the red blood cell recovery step is any one of Embodiments 25 to 38, wherein the centrifuge is operated at a slower rate during the red blood cell recovery step than during the collection step.

[0166] Embodiment 40 The method according to any one of Embodiments 25 to 39, wherein performing the red blood cell recovery step comprises measuring the weight of the plasma collection container and terminating the red blood cell recovery step based at least in part on the weight of the plasma collection container.

[0167] Embodiment 41 The method according to any one of Embodiments 25 to 40, wherein performing the additive solution flush step comprises measuring the weight of the additive solution container and terminating the additive solution flush step at least in part based on the weight of the additive solution container.

[0168] Embodiment 42 The method of performing the additive solution flush step is any one of Embodiments 25 to 41, comprising measuring the weight of the red blood cell collection container and terminating the additive solution flush step based at least in part on the weight of the red blood cell collection container.

[0169] Embodiment 43 The execution of the air evacuation step is any one of Embodiments 25 to 42, comprising measuring the weight of the red blood cell collection container and terminating the air evacuation step based at least in part on the weight of the red blood cell collection container.

[0170] Embodiment 44 A method of any one of embodiments 25 to 43, further comprising sealing a first conduit connected to a red blood cell collection container and sealing a second conduit connected to a plasma collection container at the end of the air evacuation step.

[0171] Embodiment 45 A method of any one of Embodiments 25 to 44, comprising: during the separation establishment step and the collection step, whole blood is separated in a processing vessel into plasma, red blood cells, and a buffy coat between the separated plasma and separated red blood cells; and after the completion of the red blood cell collection step, before performing the additive solution flush step, a buffy coat collection step is performed in which air from the plasma collection container is brought into the processing vessel in order to carry the buffy coat out of the processing vessel and into a buffy coat collection container.

[0172] Embodiment 46 The method of Embodiment 45, wherein performing the buffy coat collection step includes monitoring the fluid leaving the processing chamber, and terminating the red blood cell collection step when non-red blood cell fluid leaving the processing chamber is detected.

[0173] Embodiment 47 The method of any one of Embodiments 45 to 46, wherein performing the buffy coat sampling step includes monitoring the fluid leaving the processing chamber, and terminating the buffy coat sampling step when it is detected that a non-buffy coat fluid has left the processing chamber.

[0174] Embodiment 48 A method of any one of embodiments 45 to 47, further comprising sealing the conduit connected to the buffy coat collection container at the end of the air discharge step.

[0175] Embodiment 49 A blood processing apparatus comprising a pump system, a centrifuge, and a control unit, wherein the control unit is configured to operate the pump system to transport blood from a blood source to the centrifuge, to operate the centrifuge to separate the blood in the centrifuge into plasma, red blood cells, and a buffy coat between the separated plasma and separated red blood cells, to operate the pump system to transport the separated plasma and separated red blood cells out of the centrifuge, to operate the pump system to pump air into the centrifuge, and to remove and collect the buffy coat from the centrifuge.

[0176] Embodiment 50 A blood processing apparatus according to Embodiment 49, wherein the control unit is configured to control the centrifuge to operate at a slower speed when transporting the buffy coat out of the centrifuge than when transporting the separated plasma and separated red blood cells out of the centrifuge.

[0177] Embodiment 51 A blood processing apparatus according to any one of Embodiments 49 to 50, wherein separated plasma is transported out of the centrifuge via a plasma outlet, separated red blood cells are transported out of the centrifuge via a red blood cell outlet, air is transported to the centrifuge via a plasma outlet, and buffy coat is transported out of the centrifuge via a red blood cell outlet.

[0178] Embodiment 52 A blood processing apparatus according to any one of Embodiments 49 to 51, wherein the control unit is configured to continue operating the pump system to transport air to the centrifuge until a predetermined volume of fluid is discharged from the centrifuge.

[0179] Embodiment 53 A blood processing apparatus of any one of Embodiments 49 to 51, further comprising an optical sensor configured to monitor fluid exiting a centrifuge, wherein a control unit is configured to keep a pump system running to deliver air to the centrifuge until the optical sensor detects non-buffy-coated fluid exiting the centrifuge.

[0180] Embodiment 54 The blood processing apparatus according to any one of embodiments 49 to 53, wherein the blood processing apparatus is configured for use in combination with a fluid flow circuit including a plasma collection container, the control unit is configured to operate a pump system to transport air in the fluid flow circuit to the plasma collection container before operating a centrifuge to separate blood in the centrifuge, and the control unit is configured to operate the pump system to transport at least a portion of the air in the plasma collection container to the centrifuge and to carry out the buffy coat from the centrifuge for collection.

[0181] Embodiment 55 A blood processing system comprising a reusable processing unit including a pump system, a centrifuge, and a control unit, and a disposable fluid flow circuit including a processing chamber received by the centrifuge, a buffy coat collection container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit, wherein the control unit is configured to operate the pump system to transport blood from a blood source to the processing chamber, to operate the centrifuge to separate the blood in the processing chamber into plasma, red blood cells, and a buffy coat between the separated plasma and separated red blood cells, to operate the pump system to transport the separated plasma and separated red blood cells out of the processing chamber, and to operate the pump system to pump air into the processing chamber and transport the buffy coat from the processing chamber to the buffy coat collection container.

[0182] Embodiment 56: The blood processing system of Embodiment 55, wherein the control unit is configured to control the centrifuge to operate at a slower rate when transporting the buffy coat out of the processing chamber than when transporting the separated plasma and separated red blood cells out of the processing chamber.

[0183] Embodiment 57 A blood processing system according to any one of Embodiments 55 to 56, wherein separated plasma is transported out of the processing chamber via a plasma outlet port, separated red blood cells are transported out of the processing chamber via a red blood cell outlet port, air is transported out of the processing chamber via a plasma outlet port, and buffy coat is transported out of the processing chamber via a red blood cell outlet port.

[0184] Embodiment 58 A blood processing system in any one of Embodiments 55 to 57, wherein the control unit is configured to operate a pump system to continuously transport air into the processing chamber until a predetermined volume of fluid is discharged from the processing chamber.

[0185] Embodiment 59 A blood processing system according to any one of Embodiments 55 to 57, wherein the processing apparatus includes an optical sensor configured to monitor fluid leaving the processing chamber, and the control unit is configured to operate a pump system to continue transporting air into the processing chamber until the optical sensor detects non-buffycoat fluid leaving the processing chamber.

[0186] Embodiment 60 A blood processing system according to any one of Embodiments 55 to 59, wherein the fluid flow circuit includes a plasma collection container, and the control unit is configured to operate a pump system to transport air in the fluid flow circuit to the plasma collection container before operating a centrifuge to separate the blood in the processing chamber, and the control unit is configured to operate the pump system to transport at least a portion of the air in the plasma collection container into the processing chamber to transport the buffy coat from the processing chamber into a buffy coat collection container.

[0187] Embodiment 61 A method for collecting a buffy coat product, comprising: transporting blood from a blood source to a centrifuge; separating the blood in the centrifuge into plasma, red blood cells, and a buffy coat between the separated plasma and separated red blood cells; removing the separated plasma and separated red blood cells from the centrifuge; and feeding air into the centrifuge to remove the buffy coat from the centrifuge and collect it.

[0188] Embodiment 62 The method of Embodiment 61, wherein the centrifuge is operated at a slower speed when transporting the buffy coat from the centrifuge than when transporting the separated plasma and separated red blood cells from the centrifuge.

[0189] Embodiment 63 The method of any one of Embodiments 61 to 62, wherein the separated plasma is transported out of the centrifuge via the plasma outlet, the separated red blood cells are transported out of the centrifuge via the red blood cell outlet, air is transported into the centrifuge via the plasma outlet, and the buffy coat is transported out of the centrifuge via the red blood cell outlet.

[0190] Embodiment 64 A method of any one of Embodiments 61 to 63, wherein transporting air to a centrifuge includes transporting air to a centrifuge until a predetermined volume of fluid is expelled from the centrifuge.

[0191] Embodiment 65 The method of transporting air to a centrifuge is any one of Embodiments 61 to 63, comprising transporting air to the centrifuge until a non-buffycoated fluid is detected exiting the centrifuge.

[0192] Embodiment 66 The method according to any one of Embodiments 61 to 65, further comprising transporting air to a plasma collection container before separating the blood in a centrifuge, wherein transporting air to the centrifuge includes transporting at least a portion of the air in the plasma collection container into the centrifuge and transporting the buffy coat out of the centrifuge for collection.

[0193] Embodiment 67 A blood processing system comprising a reusable processing unit including a pump system, a valve system, a centrifuge, and a control unit, and a disposable fluid flow circuit including a processing chamber received by the centrifuge, an erythrocyte source container, a washed erythrocyte container, a waste container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit, wherein the control unit performs a priming step in which the pump system and the valve system cooperate to transport air in the fluid flow circuit to the waste container, and a washing step in which the pump system and the valve system cooperate to transport erythrocytes from the erythrocyte source container to the processing chamber. A blood processing system configured to perform the following steps: a centrifuge separates red blood cells into supernatant and washed red blood cells; a pump system and valve system work together to transport the supernatant from the processing chamber to a waste container; a pump system and valve system work together to transport air from the waste container to the processing chamber; a red blood cell recovery step is performed to transport washed red blood cells from the processing chamber to a washed red blood cell container; and a pump system and valve system work together to perform an air discharge step is performed to transport air from the washed red blood cell container.

[0194] Embodiment 68 A blood treatment system of Embodiment 67, wherein the fluid flow circuit includes a cleaning solution container, and the air in the fluid flow circuit is transported to a waste container using cleaning solution from the cleaning solution container during the priming stage.

[0195] Embodiment 69 The blood processing system according to any one of Embodiments 67 to 68, wherein air in a fluid flow circuit is transported into a waste container using red blood cells from a red blood cell source container.

[0196] Embodiment 70 A blood processing system according to Embodiment 69, wherein the fluid flow circuit includes a pre-wash solution container, and the control unit is configured to control a pump system and a valve system so as to mix red blood cells flowing toward the processing chamber with the pre-wash solution from the pre-wash solution container during the priming stage.

[0197] Embodiment 71 A blood processing system according to any one of Embodiments 67 to 70, wherein the processing apparatus includes an optical sensor configured to monitor a fluid leaving the processing chamber, and the control unit is configured to terminate the priming phase when the optical sensor detects a non-air fluid leaving the processing chamber.

[0198] Embodiment 72 A blood processing system according to any one of Embodiments 67 to 71, wherein the control unit is configured to control the centrifuge and keep it stationary during the priming phase.

[0199] Embodiment 73 A blood processing system in any one of Embodiments 67 to 71, wherein the control unit is configured to control the centrifuge to rotate during the priming stage.

[0200] Embodiment 74 A blood processing system in any one of Embodiments 67 to 73, wherein the fluid flow circuit includes a pre-wash solution container, and the control unit is configured to control a pump system and a valve system to mix red blood cells flowing toward the processing chamber with the pre-wash solution from the pre-wash solution container during the washing stage.

[0201] Embodiment 75 A blood processing system in any one of Embodiments 67 to 74, wherein the fluid flow circuit includes a post-washing solution container, and the control unit is configured to control a pump system and a valve system to mix the washed red blood cells flowing toward the washed red blood cell container with the post-washing solution from the post-washing solution container during the washing stage.

[0202] Embodiment 76 A blood processing system according to any one of Embodiments 67 to 75, wherein the processing apparatus includes a first pressure sensor configured to measure the hydrostatic pressure of a red blood cell source container, and the control unit is configured to terminate the washing step at least in part based on the hydrostatic pressure of the red blood cell source container.

[0203] Embodiment 77 A blood processing system according to any one of Embodiments 67 to 76, wherein the processing device includes a first weighing scale configured to measure the weight of a red blood cell source container, and the control unit is configured to terminate the washing step at least in part based on the weight of the red blood cell source container.

[0204] Embodiment 78 A blood processing system in any one of Embodiments 67 to 77, wherein the fluid flow circuit includes a post-washing solution container, and the control unit is configured to control a pump system and a valve system to mix the washed red blood cells flowing toward the washed red blood cell container with the post-washing solution from the post-washing solution container during the red blood cell recovery stage.

[0205] Embodiment 79 A blood processing system in any one of Embodiments 67 to 78, wherein the control unit is configured to control the centrifuge so that it operates at a slower rate during the red blood cell recovery stage than during the washing stage.

[0206] Embodiment 80 A blood processing system according to any one of Embodiments 67 to 79, wherein the fluid flow circuit includes a washing solution container, and the control unit is configured to perform a dilution step in which a pump system and a valve system cooperate to transport the washing solution from the washing solution container to the washed red blood cell container until a target amount of washing solution is delivered to the washed red blood cell container.

[0207] Embodiment 81 A blood processing system according to Embodiment 80, wherein the washing solution container includes a pre-washing solution container, and the pre-washing solution from the pre-washing solution container is transported to a washed red blood cell container during the dilution stage.

[0208] Embodiment 82: A blood processing system according to Embodiment 80, wherein the washing solution container includes a post-washing solution container, and the post-washing solution from the post-washing solution container is transported to a washed red blood cell container during the dilution stage.

[0209] Embodiment 83 A blood processing system according to Embodiment 80, wherein the washing solution container includes a pre-washing solution container and a post-washing solution container, and the pre-washing solution from the pre-washing solution container and the post-washing solution from the post-washing solution container are transported to a washed red blood cell container during the dilution stage.

[0210] Embodiment 84 A blood processing system in any one of Embodiments 67 to 83, wherein the processing apparatus includes a sealing system, and the control unit is configured to control the sealing system to seal the conduit connected to the washed red blood cell container at the end of the air discharge step.

[0211] Embodiment 85 A method for washing red blood cells, comprising: performing a priming step in which air in a fluid flow circuit is transported to a waste container of the fluid flow circuit; transporting red blood cells to a processing chamber of the fluid flow circuit; performing a washing step in which a centrifuge separates the red blood cells into supernatant and washed red blood cells; transporting the supernatant from the processing chamber to a waste container of the fluid flow circuit; transporting the washed red blood cells from the processing chamber to a washed red blood cell container of the fluid flow circuit; performing a red blood cell recovery step in which air from the waste container is transported into the processing chamber and the washed red blood cells are transported from the processing chamber to a washed red blood cell container; and performing an air discharge step in which air is carried out from the washed red blood cell container.

[0212] Embodiment 86 The method of Embodiment 85, wherein performing the priming step includes using a cleaning solution from a cleaning solution container of the fluid flow circuit to introduce air into a waste container.

[0213] Embodiment 87 The method according to any one of Embodiments 85 to 86, wherein the priming step is performed by using red blood cells from a red blood cell source container to carry air into a waste container.

[0214] Embodiment 88 The method of Embodiment 87, wherein the priming step is performed by mixing red blood cells flowing toward the processing chamber with a pre-wash solution from a pre-wash solution container of the fluid flow circuit.

[0215] Embodiment 89 A method of any one of Embodiments 85 to 88, wherein the execution of the priming phase includes monitoring the fluid leaving the processing chamber, and when it is detected that a non-air fluid is leaving the processing chamber, the priming phase is terminated.

[0216] Embodiment 90 The method according to any one of embodiments 85 to 89, wherein the centrifuge remains stationary during the priming stage.

[0217] Embodiment 91 A method of any one of Embodiments 85 to 89, wherein the centrifuge is rotated during the priming stage.

[0218] Embodiment 92 The method according to any one of Embodiments 85 to 91, wherein the washing step is performed by mixing red blood cells flowing toward the processing chamber with a pre-wash solution from a pre-wash solution container of the fluid flow circuit.

[0219] Embodiment 93 The washing step is performed by any one of Embodiments 85 to 92, comprising mixing the washed red blood cells flowing toward the washed red blood cell container with the washed solution from the washed solution container of the fluid flow circuit.

[0220] Embodiment 94 A method of any one of Embodiments 85 to 93, wherein performing the washing step includes measuring the hydrostatic pressure of the red blood cell source container and terminating the washing step at least in part based on the hydrostatic pressure of the red blood cell source container.

[0221] Embodiment 95 A method of any one of Embodiments 85 to 94, wherein performing the washing step includes measuring the weight of the red blood cell source container and terminating the washing step based at least in part on the weight of the red blood cell source container.

[0222] Embodiment 96 The execution of the red blood cell recovery step is any one of Embodiments 85 to 95, comprising mixing the washed red blood cells flowing toward the washed red blood cell container with the washed solution from the washed solution container of the fluid flow circuit.

[0223] Embodiment 97 The method according to any one of Embodiments 85 to 96, wherein the execution of the red blood cell recovery step includes operating the centrifuge at a slower rate during the red blood cell recovery step than during the washing step.

[0224] Embodiment 98 The method according to any one of Embodiments 85 to 97, further comprising performing a dilution step in which the washing solution from the washing solution container of the fluid flow circuit is delivered to the washed red blood cell container until a target amount of washing solution is delivered to the washed red blood cell container.

[0225] Embodiment 99 The method of Embodiment 98, wherein the washing solution container comprises a pre-washing solution container, and the dilution step includes transporting the pre-washing solution from the pre-washing solution container to a washed red blood cell container.

[0226] Embodiment 100 The method of Embodiment 98, wherein the washing solution container comprises a post-washing solution container, and the dilution step includes transporting the post-washing solution from the post-washing solution container to a washed red blood cell container.

[0227] Embodiment 101 The method of Embodiment 98, wherein the washing solution container includes a pre-washing solution container and a post-washing solution container, and the dilution step includes transporting the pre-washing solution from the pre-washing solution container and the post-washing solution from the post-washing solution container to a washed red blood cell container.

[0228] Embodiment 102 A method from any one of Embodiments 85 to 101, further comprising sealing the conduit connected to the washed red blood cell container at the end of the air removal step.

[0229] Embodiment 103 A configurable automated blood component manufacturing system comprises durable hardware components and a disposable fluid flow circuit. The durable hardware components comprise a pump station with multiple pumps, a centrifuge mounting station and drive unit, an optical system associated with the centrifuge mounting station and drive unit, a microprocessor-based control unit including a touchscreen for receiving operator input and displaying procedure parameters, hangers for suspending containers, a weighing scale associated with each hanger configured to transmit a signal to the control unit indicating the weight of the containers supported by the associated hangers, multiple tube clamps, and a cassette nesting module including multiple valves and pressure sensors. The disposable fluid flow circuit comprises a separation chamber configured to be housed in the centrifuge mounting station and drive unit, a fluid flow control cassette configured to be mounted on the cassette nesting module, the cassette having an external tube loop that can engage with a pump so that the fluid flow through the cassette is controlled by the operation of the pump and valves, and multiple containers, each fluidly communicating with the cassette by a tube segment associated with the container, with one or more of the tube segments configured to be received by one of the tube clamps. The control unit is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by the operator via input on the touchscreen, and the control unit is further configured to be programmed by the operator to perform additional blood processing procedures.

[0230] Embodiment 104 The system according to Embodiment 103, wherein the control unit is pre-programmed to perform one or more steps for generating red blood cells, plasma, and buffy coat from a single unit of whole blood; buffy coat pooling; separation of buffy coat into platelet products; addition of glycerol to red blood cells; red blood cell washing; platelet washing; and pooling and separation of cryoprecipitate.

[0231] Embodiment 105 The system according to Embodiment 103, wherein the programmable control unit is configured to receive input from an operator via a touchscreen in order to operate the system to perform non-standard blood processing procedures.

[0232] Embodiment 106 The system according to Embodiment 103, wherein a programmable control unit is configured to receive input from an operator regarding one or more of flow rate and centrifugal force for non-standard blood processing procedures.

[0233] Embodiment 107 The system according to Embodiment 103, wherein a pre-programmed blood processing procedure operates the system with preset settings for flow rate and centrifugal force, and a programmable control unit is configured to receive input from an operator regarding one or more of the speed and centrifugal force for a standard blood processing procedure that overrides the pre-programmed settings.

[0234] Embodiment 108 The system according to Embodiment 107, wherein a programmable control unit is configured to receive input from an operator to first accelerate to a first centrifugal force and / or a first flow rate over a first period, and then accelerate or decelerate to a second centrifugal force and / or a second flow rate over a second period.

[0235] It will be understood that the embodiments described above illustrate some examples of 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. A configurable automated blood component manufacturing system, Equipped with durable hardware components and disposable fluid flow circuits, The aforementioned durable hardware components are A pump station equipped with multiple pumps, Centrifuge mounting station and drive unit, The optical system associated with the centrifuge mounting station and drive unit, A microprocessor-based control unit including a touchscreen for receiving operator input and displaying procedure parameters, A hanger for hanging containers, A weighing scale associated with each hanger is configured to transmit a signal indicating the weight of the container supported by the associated hanger to the control unit, Multiple pipe clamps, It includes a cassette nesting module containing multiple valves and pressure sensors, The aforementioned disposable fluid flow circuit is A separation chamber configured to house the aforementioned centrifugal separator mounting station and drive unit, A fluid flow control cassette configured to be attached to the cassette nesting module, the cassette having an external tube loop that can engage with the pump, such that the fluid flow through the cassette is controlled by the operation of the pump and the valve, The present invention comprises a plurality of containers, each of which is in fluid communication with the cassette by a tubular segment associated with the respective container, and one or more of the tubular segments are configured to be received by one of the tubular clamps, The control unit 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. The control unit is further configured to be programmed by the operator to perform additional blood processing procedures in the system.

2. The system according to claim 1, wherein the control unit is pre-programmed to perform one or more steps for generating red blood cells, plasma, and buffy coat from a single unit of whole blood; buffy coat pooling; separation of buffy coat into platelet products; addition of glycerol to red blood cells; red blood cell washing; platelet washing; and pooling and separation of cryoprecipitate.

3. The system according to claim 1, wherein the programmable control unit is configured to receive input from the operator via the touchscreen in order to operate the system to perform non-standard blood processing procedures.

4. The system according to claim 3, wherein the programmable control unit is configured to receive input from the operator regarding one or more of the flow rate and centrifugal force for the non-standard blood processing procedure.

5. The system according to claim 1, wherein the pre-programmed blood processing procedure operates the system with preset settings for flow rate and centrifugal force, and the programmable control unit is configured to receive input from the operator regarding one or more of the speed and centrifugal force for the standard blood processing procedure that overrides the pre-programmed settings.

6. The system according to claim 5, wherein the programmable control unit is configured to receive input from the operator to first accelerate to a first centrifugal force and / or a first flow rate over a first period, and then accelerate or decelerate to a second centrifugal force and / or a second flow rate over a second period.

7. The aforementioned plurality of containers include a red blood cell collection container, a plasma collection container, and an additive solution container. The control unit, The pump station carries whole blood from the blood source to the separation chamber and performs a blood priming step that carries air in the fluid flow circuit to the plasma collection container. The centrifuge mounting station and drive unit separate the whole blood in the separation chamber into plasma and red blood cells, the pump station and the multiple valves cooperate to transport the separated plasma and red blood cells out of the separation chamber, the separated plasma and red blood cells are recombined to form recombined whole blood, and the recombined whole blood is transported to the separation chamber without transporting whole blood from the blood source to the separation chamber, thereby performing a separation establishment step. Until a total of one unit of whole blood is delivered from the blood source to the separation chamber, the pump station delivers the whole blood from the blood source to the separation chamber, the centrifuge mounting station and drive unit separate the whole blood in the separation chamber into plasma and red blood cells, the pump station and the multiple valves work together to deliver the separated plasma from the separation chamber to the plasma collection container, deliver the separated red blood cells from the separation chamber, deliver the additive solution from the additive solution container, and perform a collection step in which the separated red blood cells and additive solution are combined as a mixture and delivered into the red blood cell collection container. The pump station and the plurality of valves work together to transport air from the plasma collection container to the separation chamber, transport the separated red blood cells from the separation chamber, transport the additive solution from the additive solution container, and perform a red blood cell recovery step in which the separated red blood cells and the additive solution are subsequently combined as a mixture and transported to the red blood cell collection container. The pump station and the multiple valves work together to perform an additive solution flushing step, transporting the additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution is delivered to the red blood cell collection container. The system according to claim 1, wherein the pump station and the plurality of valves are configured to cooperate in performing an air discharge step of carrying air out of the red blood cell collection container.

8. The fluid flow circuit includes a buffy coat collection container. The whole blood is separated in the processing chamber during the separation establishment step and the collection step into plasma, red blood cells, and a buffy coat between the separated plasma and separated red blood cells. The system according to claim 7, wherein the control unit is configured to perform a buffy coat collection step, after the completion of the red blood cell collection step and before the execution of the additive solution flush step, in which the pump station and the plurality of valves cooperate to transport air from the plasma collection container into the separation chamber in order to transport the buffy coat from the separation chamber into the buffy coat collection container.

9. The control unit, The pump station is activated to transport blood from the blood source to the centrifuge mounting station and drive unit. The centrifuge mounting station and drive unit are operated to separate the blood in the centrifuge mounting station and drive unit into plasma, red blood cells, and a buffy coat between the separated plasma and the separated red blood cells. The pump station is activated to transport the separated plasma and separated red blood cells from the centrifuge mounting station and drive unit. The system according to claim 1, wherein the pump station is configured to operate to supply air to the centrifugal separator mounting station and drive unit, and the buffy coat is carried out from the centrifugal separator mounting station for collection.

10. The aforementioned plurality of containers include plasma collection containers, The control unit is configured to transport air in the fluid flow circuit into the plasma collection container before operating the pump station to operate the centrifuge mounting station and drive unit to separate the blood in the centrifuge mounting station and drive unit. The system according to claim 9, wherein the control unit is configured to operate the pump station to transport at least a portion of the air in the plasma collection container into the centrifuge mounting station and drive unit, and to transport the buffy coat from the centrifuge mounting station and drive unit for collection.

11. The aforementioned plurality of containers include a buffy coat collection container, The control unit, The pump station is activated to transport blood from the blood source to the separation chamber. To separate the blood in the separation chamber into plasma, red blood cells, and a buffy coat between the separated plasma and red blood cells, the centrifuge mounting station and drive unit are activated. The pump station is activated to transport the separated plasma and separated red blood cells out of the separation chamber. The system according to claim 1, wherein the pump station is operated to send air into the separation chamber and transport the buffy coat from the separation chamber to a buffy coat collection container.

12. The separated plasma is carried out from the separation chamber via the plasma outlet port. The separated red blood cells are transported out of the separation chamber via the red blood cell exit port. The air is delivered to the separation chamber via the plasma outlet port. The system according to claim 11, wherein the buffy coat is transported out of the separation chamber via the red blood cell exit port.

13. The aforementioned plurality of containers include a red blood cell source container, a washed red blood cell container, and a waste container. The control unit, The pump station and the plurality of valves work together to perform a priming step in which air in the fluid flow circuit is transported to the waste container. The pump station and the plurality of valves work together to transport red blood cells from the red blood cell source container to the separation chamber, the centrifuge mounting station and drive unit separate the red blood cells into supernatant and washed red blood cells, the pump station and the plurality of valves work together to transport the supernatant from the separation chamber to the waste container, and perform a washing step to transport the washed red blood cells from the separation chamber to the washed red blood cell container. The pump station and the multiple valves work together to transport air from the waste container to the separation chamber, and perform a red blood cell recovery step in which washed red blood cells are transported from the separation chamber to the washed red blood cell container. The system according to claim 1, wherein the pump station and the plurality of valves are configured to cooperate in performing an air discharge step of carrying air out of the washed red blood cell container.

14. The aforementioned plurality of containers include a washing solution container, The system according to claim 13, wherein the control unit is configured to perform a dilution step in which the pump station and the plurality of valves cooperate to transport the washing solution from the washing solution container to the washed red blood cell container until a target amount of washing solution is delivered to the washed red blood cell container.

15. A method for separating blood, using the system described in any one of claims 1 to 14.

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