Red blood cell additive solution management and storage of red blood cell products

Abstract

A blood treatment system includes a durable hardware component and a disposable fluid flow circuit. The hardware component includes a controller configured to execute a procedure of separating red blood cells from whole blood and collecting red blood cells. The additive solution may be initially disposed in a red blood cell collection container of the fluid flow circuit, and the controller actuates a pump system of the hardware component to deliver the additive solution from the red blood cell collection container into an additive solution container of the fluid flow circuit. After separating red blood cells from blood and delivering it (along with at least a portion of the additive solution from the additive solution container) into a red blood cell collection container, the red blood cells and the additive solution in the red blood cell collection container may be delivered into a whole blood container for collection and storage.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 347,382 filed on May 31, 2022, the contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to separating and collecting red blood cells ("RBCs") from blood. More specifically, the present disclosure relates to apparatus and methods for managing red blood cell additive solutions and / or for storing red blood cell products using one or more containers that do not contain di-2-ethylhexyl phthalate ("DEHP"). Background Art

[0004] Blood and blood components are widely used in medical applications. Usually, whole blood collected from a donor is further processed. Usually, the blood is processed to obtain blood components, such as RBC, plasma and platelets. This can be done, for example, by collecting whole blood, then by filtering and then by centrifugation, by collecting whole blood, then by centrifugation and then by filtering, or by automatically collecting each component.

[0005] RBCs are usually separated from collected whole blood and later transfused to patients in need of RBCs. For example, RBCs can be administered to patients who have suffered blood loss due to trauma, as a follow-up to chemotherapy, or as part of a treatment for one or more blood-borne diseases. Unless administered immediately after collection and separation, red blood cells are usually stored for a period of time before transfusion. The storage period may vary from a few days to a few weeks.

[0006] Typically, materials and solutions based on plasticized polyvinyl chloride ("PVC") are used for collecting, handling, storing and transfusing blood and blood components. PVC is highly preferred for these applications, particularly for use in infusion systems, due to its properties. However, PVC is rather brittle and is therefore used together with plasticizers or extractables to ensure the required flexibility and softness of the material. Therefore, phthalates (hereinafter also referred to as "phthalates"), such as DEHP, are often used as plasticizers or extractables for PVC.

[0007] Although DEHP is an effective plasticizer or extractable agent for PVC, DEHP can leach from the container of the extracorporeal fluid flow circuit into the (biological or non-biological) fluid stored in the container. DEHP has been found to improve RBC quality (by reducing hemolysis) during storage, but some recipients of blood or blood components, such as pregnant women and newborns, are considered to be particularly sensitive to DEHP (and may have adverse health effects) due to the greater possibility of reaction. Therefore, although leaching of DEHP plasticizer from the materials used can have a positive impact on the quality of blood components, there is an increasing need to provide blood and blood components that are substantially free of DEHP (or more preferably substantially free of phthalates) to individuals in need. Summary of the invention

[0008] There are several aspects of the subject matter that can be embodied individually or together in the devices and systems described and claimed below. These aspects can be used alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the use of these aspects alone or to exclude the claiming of these aspects alone or in a combination different from the combination set forth in the claims attached hereto.

[0009] In one aspect, a blood processing system includes a reusable processing device and a disposable fluid flow circuit. The processing device has a pump system, a blood separation component, and a controller configured to perform a blood processing procedure. The disposable fluid flow circuit has a processing chamber received by the blood separation component, a red blood cell collection container containing an additive solution, an additive solution container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit. The controller is configured to actuate the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container, actuate the pump system to transfer blood from a blood source to the processing chamber, and actuate the blood separation component to separate red blood cells from the blood in the processing chamber. The controller then actuates the pump system to transfer at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and actuates the pump system to transfer at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0010] In another aspect, a method for separating red blood cells from whole blood is provided. The method includes transferring an additive solution from a red blood cell collection container to an additive solution container, transferring blood from a blood source to a processing chamber, and then separating red blood cells from the blood in the processing chamber. Transferring at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and transferring at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0011] On the other hand, a blood processing system includes a reusable processing device and a disposable fluid flow circuit. The processing device has a pump system, a blood separation component, and a controller configured to perform a blood processing procedure. The fluid flow circuit has a processing chamber received by the blood separation component, a red blood cell collection container, a whole blood container, and a plurality of conduits that fluidly connect the components of the fluid flow circuit. The controller is configured to actuate the pump system to transport blood from the whole blood container to the processing chamber, and then actuate the blood separation component to separate red blood cells from the blood in the processing chamber. The controller then actuates the pump system to transport at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and then actuates the pump system to transport the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0012] In another aspect, a method for separating red blood cells from whole blood is provided. The method includes transferring blood from a whole blood container into a processing chamber, and then separating red blood cells from the blood in the processing chamber. Next, transferring at least a portion of the separated red blood cells out of the processing chamber and into a red blood cell collection container, and then transferring the at least a portion of the separated red blood cells out of the red blood cell collection container and into a whole blood container.

[0013]

[0011] These and other aspects of the inventive subject matter are set forth in the following detailed description of the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 is a perspective view of an exemplary reusable hardware component of a blood processing system configured to receive a disposable fluid flow circuit;

[0015] Figure 2 is used with Figure 1 A plan view of an exemplary disposable fluid flow circuit for use in conjunction with the durable hardware components;

[0016] Figure 3 Is installed to Figure 1 A processing device to complete the blood processing system according to one aspect of the present disclosure Figure 2 A schematic diagram of a fluid flow circuit;

[0017] Figure 4 yes Figure 3 A schematic diagram of a blood processing system performing an "additive solution transfer" phase of an exemplary blood processing procedure;

[0018] Figure 5 yes Figure 3 Schematic diagram of a blood processing system performing a "blood priming" phase of an exemplary blood processing procedure;

[0019] Figure 6 yes Figure 3 Schematic diagram of a blood processing system performing a "set up separation" phase of an exemplary blood processing procedure;

[0020] Figure 7 yes Figure 3 A schematic diagram of a blood processing system of performing a "collection" phase of an exemplary blood processing procedure, wherein separated RBCs are leukoreduced prior to collection;

[0021] Figure 8 yes Figure 7 Schematic diagram of a variation of the "collection" phase of , wherein the separated red blood cells are not leukoreduced prior to collection;

[0022] Fig. 9 yes Figure 3 A schematic diagram of a blood processing system of performing a "red blood cell recovery" phase of an exemplary blood processing procedure, wherein separated red blood cells are leukoreduced prior to collection;

[0023] Fig.10 yes Fig. 9 Schematic diagram of a variation of the "red blood cell recovery" stage of , wherein the separated red blood cells are not leukoreduced prior to collection;

[0024] Fig.11 yes Figure 3 A schematic diagram of a blood processing system of performing an "additive solution flush" phase of an exemplary blood processing procedure, wherein an additive solution is directed through a leukocyte reduction filter prior to entering a red blood cell collection container;

[0025] Fig.12 yes Fig.11 Schematic diagram of a variation of the "additive solution flush" stage of FIG. 1 , wherein the additive solution enters the red blood cell collection container without passing through the leukocyte reduction filter;

[0026] Fig.13 yes Figure 3 Schematic diagram of a blood processing system performing the "red blood cell transfer" and "air evacuation" phases of an exemplary blood processing procedure; and

[0027] Fig.14 yes Figure 3 Schematic diagram of a blood processing system performing a "sealing" phase of an exemplary blood processing procedure. DETAILED DESCRIPTION

[0028] The embodiments disclosed herein are for the purpose of providing 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. Therefore, the specific designs and features disclosed herein should not be interpreted as limiting the subject matter defined in the appended claims.

[0029] The embodiments disclosed herein are for the purpose of providing an exemplary description of the present subject matter. However, they are only exemplary and not exclusive, and the present subject matter can be embodied in various forms. Therefore, the specific details disclosed herein should not be interpreted as limiting the subject matter defined in the appended claims.

[0030] Figure 1 A reusable or durable hardware component or processing device, generally indicated at 10, of a configurable automated blood processing system or blood component manufacturing system is depicted, and Figure 2 A disposable or single-use fluid flow circuit is depicted, generally indicated at 12, to be used in conjunction with a processing device 10 for processing collected whole blood. The illustrated processing device 10 and fluid flow circuit 12 are generally constructed as described in PCT Patent Application Publication No. WO 2021 / 194824 A1 (which PCT Patent Application Publication is hereby incorporated by reference herein), but it should be understood that the processing device 10 and the associated fluid flow circuit 12 may be constructed in different ways without departing from the scope of the present disclosure.

[0031] The illustrated processing apparatus 10 includes associated pumps, valves, sensors, displays, and other equipment, described in more detail below, for configuring and controlling fluid flow through the fluid flow circuit 12. The blood processing system may be directed by a controller integrated with the processing apparatus 10, the controller including a programmable microprocessor to automatically control the operation of the pumps, valves, sensors, etc. The processing apparatus 10 may also include wireless communication capabilities to enable data to be transmitted from the processing apparatus 10 to an operator's quality management system.

[0032] More specifically, the illustrated processing device 10 includes: a user input and output touch screen 14; a pump station or system, the pump station or system including a first pump 16 (for pumping, for example, whole blood), a second pump 18 (for pumping, for example, plasma) and a third pump 20 (for pumping, for example, an additive solution); a centrifuge mounting station and a drive unit 22 (the drive unit 22 may be referred to herein as a "centrifuge"); and clamps 24a to 24c. Although blood separation is described herein as being achieved via centrifugation, it should be understood that the present disclosure is not limited to blood separation via centrifugation, but includes any suitable method and blood separation component for separating blood into two or more components. For example, in one embodiment, the centrifuge can be replaced with a rotating membrane blood separation component of the type described in U.S. Patent Application Publication No. 2019 / 0201916, which is hereby incorporated by reference herein.

[0033] Touch screen 14 enables user interaction with processing device 10 and monitoring of program parameters such as flow rate, container weight, pressure, etc. Pump 16, pump 18 and pump 20 (collectively referred to herein as part of the "pump system" of processing device 10) are illustrated as peristaltic pumps that can receive pipes or conduits and move fluids through associated conduits at various rates depending on the program being executed. An exemplary centrifuge mounting station / drive unit is shown in U.S. Patent No. 8,075,468 (see Figures 26 to 28), which is incorporated herein by reference. Clamps 24a to 24c (collectively referred to herein as part of the "valve system" of processing device 10) can open and close the fluid path through the pipe or conduit and can be combined with RF sealants to complete the heat sealing of the pipe or conduit placed in the clamp when the program is completed, thereby sealing the pipe or conduit leading to the product container.

[0034] Aseptic connection / docking devices may also be incorporated into one or more of the clamps 24a to 24c. Aseptic connection devices may employ any of several different operating principles. For example, known aseptic connection devices and systems include radiant energy systems that melt the facing membrane of a fluid flow conduit, such as in U.S. Pat. No. 4,157,723; heated wafer systems that employ wafers for cutting pipe sections and thermally bonding or splicing the pipe sections together while the ends remain molten or semi-molten, such as in U.S. Pat. Nos. 4,753,697, 5,158,630, and 5,156,701; and systems that employ removable closure membranes or nets that are sealed to the ends of pipe sections, such as described in U.S. Pat. No. 10,307,582. Alternatively, a sterile connection can be formed by compressing or clamping a sealed tubing segment, heating and cutting the sealed end, and joining the tubing to a similarly treated tubing segment, such as in U.S. Patent Nos. 10,040,247 and 9,440,396. All of the above patents are incorporated by reference in their entirety. Sterile connection devices based on other operating principles may also be employed without departing from the scope of the present disclosure.

[0035] The processing device 10 also includes hangers 26a to 26d (the hangers can each be associated with a scale) for hanging various containers of the disposable fluid circuit 12. The hangers 26a to 26d are preferably mounted to a support 28 that can be vertically translated to enhance the transportability of the processing device 10. An optical system including a laser 30 and a photodetector 32 is associated with the centrifuge 22 for determining and controlling the position of the interface between the separated blood components in the centrifuge 22. An exemplary optical system is shown in U.S. Patent Application Publication No. 2019 / 0201916. An optical sensor 34 is also provided to optically monitor one or more conduits entering and exiting the centrifuge 22.

[0036] The surface of the processing device 10 includes a nesting module 36 for housing a flow control cassette 50 ( Figure 2 ). The cartridge nesting module 36 is configured to receive a variety of disposable cartridge designs so that the system can be used to perform different types of procedures. The illustrated cartridge nesting module 36 has embedded therein four valves 38a-38f (collectively referred to herein as part of the "valve system" of the processing device 10) for opening and closing the fluid flow path within the flow control cartridge 50 and three pressure sensors 40a-40c capable of measuring pressure at different locations of the fluid flow circuit 12.

[0037] Reference Figure 2, the illustrated fluid flow circuit 12 includes a plurality of containers 42, 44, 46, and 48, as well as a flow control cartridge 50 and a processing / separation chamber 52 configured to be received in a centrifuge 22, all of which are interconnected by conduits or tubing segments to allow for continuous flow centrifugation. The flow control cartridge 50 routes the fluid to flow through three tubing loops 54, 56, 58, wherein each loop is positioned to engage a specific one of the pumps 16, 18, 20. The conduits or tubing may extend through the cartridge 50, or the cartridge 50 may have a preformed fluid flow path that directs the flow of the fluid.

[0038] exist Figure 2 In the fluid flow circuit 12 shown in FIG. 1 , 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 RBC separated from whole blood, and container 48 may be an empty container for receiving plasma separated from whole blood. Figure 2 A whole blood container 44 (e.g., configured as a blood pack unit) is shown as the blood source, but it is also within the scope of the present disclosure that the blood source is a living donor, as will be described in more detail herein. Additionally, although container 42 can be pre-filled with an additive solution, it is also within the scope of the present disclosure that container 42 is empty and one of the other containers is pre-filled with an additive solution, wherein all or a portion of the additive solution is delivered to container 42 during the blood processing process (as will be described in more detail herein). The fluid flow circuit can optionally include: an air collector 60 ( Figure 3 ), whole blood flows through an air collector 60 before entering the processing chamber 52; and / or a leukocyte reduction filter 62, red blood cells flow through a leukocyte reduction filter 62 before entering the red blood cell collection container 46.

[0039] The processing chamber 52 can be preformed into the desired shape and configuration by injection molding of a rigid plastic material, as shown and described in U.S. Patent No. 6,849,039, which is incorporated herein by reference. The specific geometry of the processing chamber 52 can vary depending on the elements to be separated, and the present disclosure is not limited to the use of any particular chamber design. For example, it is within the scope of the present disclosure that the processing chamber 52 is composed of a generally flexible material rather than a generally rigid material. When the processing chamber 52 is formed of a generally flexible material, the processing chamber 52 relies on the centrifuge 22 to define the shape of the processing chamber 52. Exemplary processing chambers and associated centrifuges formed of flexible materials are described in U.S. Patent No. 6,899,666, which is incorporated herein by reference.

[0040] In an exemplary embodiment, the controller of the processing device 10 is preprogrammed to automatically operate the system to perform one or more standard blood processing procedures selected by the operator through input to the touch screen 14, and the controller is configured to be further programmed by the operator to perform additional blood processing procedures. The controller can be preprogrammed to substantially automate various procedures, including, but not limited to: production of RBCs and plasma from a single unit of whole blood (as will be described in more detail herein), buffy coat pooling, separation of buffy coats into platelet products (as described in U.S. Patent Application Publication No. 2018 / 0078582, which is hereby incorporated by reference), addition of glycerol to RBCs, RBC washing, platelet washing, and cryoprecipitate pooling and separation.

[0041] The preprogrammed blood processing program operates the system at preset flow rate and centrifugal force settings, and the programmable controller can also be configured to receive input from an operator regarding one or more of the flow rate and centrifugal force for a standard blood processing program to override the preprogrammed settings.

[0042] In addition, the programmable controller is configured to receive input from an operator via touch screen 14 for operating the system to perform non-standard blood processing procedures. More specifically, the programmable controller can be configured to receive input for settings of non-standard blood processing procedures, including flow rate and centrifugal force.

[0043] In an exemplary procedure, the processing device 10 and the fluid flow circuit 12 may be used in combination to process an amount (eg, one unit) of whole blood into a red blood cell product and a plasma product. Figure 3 is a schematic diagram of a fluid flow circuit 12 mounted to a treatment device 10, wherein selected components of the fluid flow circuit 12 and selected components of the treatment device 10 are shown. Figures 4 to 14 Different stages of an exemplary blood processing procedure are shown.

[0044] As described above, it is within the scope of the present disclosure that the additive solution container 42 is pre-filled with the additive solution, or that the additive solution container 42 is empty and some other container is pre-filled with the additive solution. For example, in the illustrated embodiment, the additive solution container 42 is empty (or at least substantially empty) and the red blood cell collection container 46 is pre-filled with the additive solution (e.g., ). The advantage of this configuration is that it allows the use of a non-DEHP plasticized container (i.e., red blood cell collection container 46) to store the RBCs produced during the blood separation process, while the additive solution container 42 can be formed of a material that includes DEHP. This method reduces the time and cost of performing a blood separation procedure compared to conventional methods.

[0045] More specifically, the additive solution is usually contained in a dedicated additive solution container. The container filled with the additive solution may not be sterilized by radiation, so that the additive solution container must be arranged separately from the rest of the associated fluid flow circuit (which is sterilized via radiation) and sterilized separately (e.g., using steam). Once the additive solution container is sterilized, the additive solution container is connected in a sterile manner to one of the conduits of the fluid flow circuit only before using the fluid flow circuit.

[0046] Similar to containers filled with additive solutions, containers formed of materials that do not contain DEHP (such as citrate plasticized materials) are also incompatible with radiation sterilization and therefore also require aseptic connection to the associated fluid flow circuit after sterilization. Therefore, when the fluid flow circuit is provided with a non-DEHP red blood cell collection container and an additive solution container pre-filled with an additive solution, it is necessary to aseptically connect these two containers to the rest of the fluid flow circuit, which increases the time and cost of any blood separation procedure. On the other hand, if the additive solution is initially provided in a non-DEHP red blood cell collection container 46, only one aseptic connection (the aseptic connection of the non-DEHP red blood cell collection container 46) is required because the empty additive solution container 42 (which can be formed of a material including DEHP) can be pre-attached to the fluid flow circuit 12 and radiated sterilized together with the fluid flow circuit 12. It should be clear that this reduces the time and cost of performing a blood separation procedure.

[0047] Once the red blood cell collection container 46 (which may be formed of a citrate plasticized material or any other suitable non-DEHP material) filled with the additive solution is attached to the rest of the fluid flow circuit 12, the initial step of the blood processing procedure may be performed to transfer the additive solution from the red blood cell collection container 46 to the additive solution container 42. When this "additive solution transfer" phase (e.g., Figure 4 Once completed, the blood processing procedure can proceed as usual.

[0048] During the additive solution transfer phase, the additive solution is sucked out from the red blood cell collection container 46 via line L12 by operating the third pump 20 (which may be referred to as an "additive pump"). The clamp 24b and valve 38b are opened, while the other clamps and valves are closed, which directs the additive solution from line L12 into and through line L13, then into and through line L8, then into and through line L5, and then through line L10 and into the additive solution container 42. It should be understood that during Figures 4 to 14 In the figure, the arrow on the container indicates the direction of fluid flow between the container and the conduit connected to the container. For example, the line L12 is shown as being connected to the top of the red blood cell collection container 46 so that the upward arrow (such as Figure 4 ) indicates that fluid flows upward from the red blood cell collection container 46. In contrast, line L10 is shown connected to the bottom of the additive solution container 42 so that the upward arrow (as shown in FIG. Figure 4 ) indicates that the fluid flows upward into the additive solution container 42.

[0049] although Figure 4 The additive solution is shown disposed about the leukocyte reduction filter 62, but it is within the scope of the present disclosure to pump the additive solution through the leukocyte reduction filter 62 instead (by closing valve 38b and opening valve 38d). In either case, the additive solution transfer phase can continue until all or a specified amount of the additive solution has been transferred from the red blood cell collection container 46 to the additive solution container 42, which can be determined by measuring the weight of either or both of the containers 42 and 46, by monitoring the operation of the additive pump 20 (to ensure that the appropriate volume of fluid has been transferred from the red blood cell collection container 46), or by any other suitable method.

[0050] Once the additive solution is in the additive solution container 42 (whether initially disposed in the additive solution container 42 or delivered to the additive solution container 42 during an additive solution transfer phase), the procedure may proceed to what is referred to herein as the "blood priming" phase. Figure 5 ), selected components of the fluid flow circuit 12 are primed with blood from a blood source. Figure 5 4. The whole blood container 44 is shown in FIG. 4, but may alternatively be a living donor. Thus, it should be understood that the term "whole blood" may refer to blood including or not including anticoagulation fluid.

[0051] During the blood priming stage, whole blood is pumped from a blood source ( ) via line L1 by operating a first pump 16 (the first pump 16 may be referred to as a “whole blood pump”). Figure 5 The whole blood container 44 in the embodiment of the present invention is drawn into the fluid flow circuit 12. Valves 38c and 38f are closed, thereby directing the blood through the pressure sensor 40c and into and through the pipeline L2. The blood passes through the air collector 60, the pressure sensor 40a (which measures the pressure of 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.

[0052] The centrifuge 22 may be stationary during the blood priming phase, or may alternatively be controlled by a controller of the processing device 10 to rotate at a low rotation rate (e.g., approximately 1000 rpm to 2000 rpm). It may be advantageous for the centrifuge 22 to rotate during the blood priming phase in order to generate sufficient gravity to ensure that the air in the processing chamber 52 (including air already present in the processing chamber 52, and air moved into the processing chamber 52 from lines L1 and / or L2 by blood flow) is forced close to the low gravity (radially inner) wall of the processing chamber 52. Higher centrifuge rotation rates, such as 4500 rpm (which is required for steady-state separation, as described below) may be undesirable because air pockets (air is trapped in the air pockets and may not be forced out of the processing chamber 52, thereby causing a pressure increase) are more likely to occur at higher gravity.

[0053] Blood entering the processing chamber 52 will move toward the high gravity (radially outer) wall of the processing chamber 52, thereby forcing the air to approach the low gravity wall. The plasma outlet port of the processing chamber 52 is associated with the low gravity wall of the processing chamber 52, so that most of the air will leave the processing chamber 52 via the plasma outlet port and associated line L3, although some air may also leave the processing chamber 52 via the red blood cell outlet port associated with the high gravity wall of the processing chamber 52.

[0054] Valves 38b and 38d are closed, while the second pump 18 (which may be referred to as a "plasma pump") is enabled and the additive pump 20 is disabled. This arrangement will direct the air leaving the processing chamber 52 via the red blood cell outlet port through the associated line L4 and pressure sensor 40b into line L5, and then into line L6. Valve 38a is opened so that the air flowing through line L6 will meet the air flowing through line L3 (i.e., the air leaving the processing chamber 52 via the plasma outlet port). The combined air will flow through line L7 and the open clamp 24c into the plasma collection container 48.

[0055] The air flow out of the processing chamber 52 via either outlet port is monitored by an optical sensor 34 that is capable of determining the optical density of the fluid flowing through the monitoring lines and discriminating between air fluid and non-air fluid in lines L3 and L4. When non-air fluid is detected in both lines L3 and L4, the controller of the processing device 10 will end the blood priming phase and proceed to the next phase of the procedure. The amount of blood drawn into the fluid flow circuit 12 from the blood source during the blood priming phase will vary depending on a number of factors (e.g., the amount of air in the fluid flow circuit 12), but may be approximately 50 to 100 milliliters. The blood priming phase may take approximately one to two minutes.

[0056] although Figure 5 While the fluid flow circuit 12 is illustrated as being primed with blood, it should be understood that the fluid flow circuit 12 may be primed with a separately provided fluid (eg, anticoagulant or saline) (as desired).

[0057] The next stage (such as Figure 6 ) is referred to herein as the "establish separation" stage. Once non-air fluid is detected in pipelines L3 and L4, the rotation rate of centrifuge 22 will be increased to a rate sufficient to separate the blood into concentrated red blood cells and platelet-poor plasma (e.g., the rate may be in the range of about 4500rpm to 5500rpm). In order to produce a plasma product with a low platelet content, it may be advantageous for the processing chamber 52 to be configured to have a plasma outlet port that is spaced apart from the blood inlet port and positioned downstream of the blood inlet port, rather than positioned adjacent to the blood inlet port. This configuration allows platelets to precipitate into different layers (commonly referred to as "buffy coats") between plasma and red blood cells before the plasma is removed from the processing chamber 52, thereby allowing the separated plasma to be platelet-deficient. As for the whole blood pump 16, the whole blood pump 16 continues to operate, but no additional blood is drawn into the fluid flow circuit 12 from the blood source during the establishment separation stage (as will be described).

[0058] If the blood source includes (in the case of a whole blood container) or only provides (in the case of a living donor) a limited amount (e.g., a single unit) of whole blood, the system must operate with limited fluid volumes. To avoid product loss or quality issues, the plasma and RBCs that are initially separated from the blood in and removed from the processing chamber 52 are not directed to their respective collection containers, but are mixed together to form reconstituted whole blood and recirculated back into the processing chamber 52.

[0059] More specifically, during the separation setup phase, separated plasma will exit the processing chamber 52 via the plasma outlet port and associated line L3. During this phase, the clamp 24c is closed, while the valve 38a remains open, thereby directing the plasma from line L3 into line L6. The separated RBCs 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 RBCs 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, a pump associated with the red blood cell outlet line may be provided instead of a pump associated with 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 may be provided.

[0060] The additive pump 20 is deactivated during this phase, thereby directing red blood cells from line L4 into line L5. The plasma flowing through line L6 mixes with the RBCs flowing through line L5 at the junction of the two lines L5 and L6 to form reconstituted whole blood. Valve 38d is closed, thereby introducing the reconstituted whole blood into line L8. Valve 38b is also closed, thereby introducing the reconstituted whole blood from line L8 into line L9 and through the open valve 38c. With the clamp 24a closed, the whole blood pump 16 draws the reconstituted whole blood from line L9 into line L2 (rather than drawing additional blood from the blood source into the fluid flow circuit 12), wherein the reconstituted blood passes through the air collector 60, the pressure sensor 40a, and the optical sensor 34 before flowing back into the processing chamber 52, where the reconstituted blood is again separated into plasma and RBCs.

[0061] The establishment separation phase continues until steady-state separation is achieved, which may take about one to two minutes. As used herein, the term "steady-state separation" refers to a state in which blood is separated into its components in the processing chamber 52, wherein the radial position of the interface between the separated components in the processing chamber 52 remains at least substantially unchanged (rather than moving radially inward or radially outward). The position of the interface can be determined and controlled according to any suitable method, including the use of an interface detector of the type described in U.S. Patent Application Publication No. 2019 / 0201916.

[0062] Preferably, steady-state separation is achieved by having the interface between the separated components in the processing chamber 52 at a target position. The target position may correspond to the position of the interface at which the separation efficiency is optimized, wherein the exact position varies according to many factors (e.g., the hematocrit of whole blood). However, in an exemplary embodiment, the target position of the interface may be the position of the interface when approximately 52% of the thickness or width of the channel (in the radial direction) 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 may be adjusted by changing the flow rate of the plasma pump 18, wherein the flow rate is increased to draw more separated plasma from the processing chamber 52 (which reduces the thickness of the plasma layer in the processing chamber 52) and moves the interface toward the low gravity wall, or the flow rate is reduced to draw less plasma from the processing chamber 52 (which increases the thickness of the plasma layer in the processing chamber 52) and moves the interface toward the high gravity wall.

[0063] In an exemplary procedure, the controller of the processing device 10 will control the whole blood pump 16 to operate at a constant rate, while the plasma pump 18 initially operates at the same rate, which will rapidly increase the thickness of the red blood cell layer within the processing chamber 52 and move the interface toward the low gravity wall. As the thickness of the red blood cell layer increases and the position of the interface approaches the target position, the rate of the plasma pump 18 is gradually reduced. As described above, the target position of the interface can depend on the hematocrit of the whole blood, which means that the rate of the plasma pump 18 (which controls the position of the interface) can also depend on the hematocrit of the whole blood. In one embodiment, this relationship can be expressed as follows:

[0064] Theoretical plasma pump rate = whole blood pump rate - ((whole blood hematocrit * whole blood pump rate) / hematocrit of separated red blood cells) [Equation 1]

[0065] The hematocrit of the whole blood can be measured before the procedure begins, or during the procedure by optical sensor 34, while the hematocrit of the separated RBCs can be determined during the procedure by monitoring line L4 by optical sensor 34. In practice, once steady-state separation is achieved and the interface is at the target position, the plasma pump rate will generally not remain at the theoretical rate, but instead the plasma pump rate will tend to "fluctuate" around the theoretical rate.

[0066] Regardless of the specific manner in which the controller of the processing device 10 executes the establishment separation phase and reaches a steady-state separation, once a steady-state separation is established, the controller will end the establishment separation phase and advance the process to the "collection" phase, such as Figure 7 At the beginning of the collection phase, the centrifuge 22, the whole blood pump 16, and the plasma pump 18 all continue to operate at the same rate at which they were operating at the end of the establishment separation phase. However, the valve system of the processing device 10 is adjusted to direct the separated plasma and red blood cells to their respective collection containers (rather than reconstituting the plasma and red blood cells and recycling the plasma and red blood cells through the centrifuge 22) while allowing additional blood to be drawn into the fluid flow circuit 12 from the blood source until a target amount (e.g., one unit) of whole blood is drawn into the fluid flow circuit 12.

[0067] More specifically, during the collection phase, valve 38c is closed and clamp 24a is opened, which causes whole blood pump 16 to draw additional blood from a blood source (which in the illustrated embodiment is whole blood container 44, but may be a living donor) into line L1. Whole blood pump 16 draws blood from the blood source from line L1 into line L2, where the blood passes through air collector 60, pressure sensor 40a, and optical sensor 34 before flowing into processing chamber 52, where the blood is separated into plasma and red blood cells. Most of the platelets in the whole blood will remain in processing chamber 52 along with some white blood cell populations (such as monocytes), while larger white blood cells, such as granulocytes, may leave with the concentrated red blood cells.

[0068] The separated plasma exits the processing chamber 52 via the plasma outlet port and associated line L3. Valve 38a is closed, thereby directing the plasma from line L3 into line L7, through the open clamp 24c, and into the plasma collection container 48.

[0069] As for the separated RBCs, the separated RBCs leave the processing chamber 52 via the red blood cell outlet port and the associated line L4. The additive pump 20 is operated by the controller to draw the additive solution from the additive solution container 42 via the line L10. The RBCs flowing through the line L4 are mixed with the additive solution flowing through the line L10 at the junction of the two lines L4 and L10 to form a mixture that continues to flow into and through the line L5. The mixture is ultimately directed to the red blood cell collection container 46, but may first be conveyed through the leukocyte reduction filter 62 (if provided), as shown in FIG. Figure 7 Even if a leukocyte reduction filter 62 is provided, the valve system can 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 FIG. Figure 8 It is also within the scope of the present disclosure to route the mixture through the leukoreduction filter 62 at the beginning of the collection phase, and reconfigure the valve system during the collection phase to allow the mixture to bypass the leukoreduction filter 62 so that only a portion of the collected RBCs are leukoreduced.

[0070] exist Figure 7 In the configuration of (where the mixture is leukocyte-reduced), valves 38a, 38b, and 38c are closed, and valve 38d is opened, thereby directing the mixture from line L5 into line L11. The mixture flows through the open valve 38d and the leukocyte-reducing filter 62 and into line L12. The leukocyte-reduced mixture then flows through the open clamp 24b and into the red blood cell collection container 46.

[0071] exist Figure 8In the configuration of (where the mixture is not leukoreduced), valves 38a, 38c, and 38d are closed, and valve 38b is opened, thereby directing the mixture from line L5 into line L8, and then into line L13. The mixture flows through the open valve 38b and into line L12, thereby bypassing the leukoreduction filter 62. The mixture that is not leukoreduced then flows through the open clamp 24b and into the red blood cell collection container 46.

[0072] As described above, the mixture may be routed through a leukocyte reduction filter 62 (e.g., Figure 7 ), and during the collection phase the valve system is reconfigured to allow the mixture to bypass the leukocyte reduction filter 62 (as shown in FIG. Figure 8 ), so that only a portion of the collected red blood cells are leukoreduced. In one embodiment, pressure sensor 40b monitors the pressure of leukoreduction filter 62. If pressure sensor 40b detects that the pressure of leukoreduction filter 62 has risen above a predetermined pressure threshold (which may indicate filter clogging), the controller can reconfigure the valve system (from Figure 7 Configuration to Figure 8 configuration) so that the mixture bypasses the leukocyte reduction filter 62. The system can then remind the operator that the RBC product is not leukocyte-reduced.

[0073] Regardless of whether the collected RBCs have been leukoreduced (or only partially leukoreduced), the collection phase will continue until the target amount of whole blood is drawn from the blood source into the fluid flow circuit 12. In the case where a whole blood container 44 is used as the blood source (as in the illustrated embodiment), the collection phase will end when the whole blood container 44 (which can be filled with the target amount of whole blood) is empty, where different methods may be used to determine when the whole blood container 44 is empty. For example, in one embodiment, the pressure sensor 40c monitors the static pressure of the whole blood container 44. When the static pressure measured by the pressure sensor 40c is at or below a threshold, an empty whole blood container 44 can be detected. Alternatively (or additionally), the weight of the whole blood container 44 can be monitored by a scale, where an empty whole blood container 44 is detected when the weight is at or below a threshold. In the case of a living donor (or in the event that the whole blood container 44 is provided with more than a target amount of blood), the volumetric flow rate of the whole blood pump 16 can be used to determine when the target amount of whole blood has been drawn into the fluid flow circuit 12.

[0074] Once the target amount of whole blood has been drawn into the fluid flow circuit 12, the controller will switch the program to the "red blood cell recovery" phase. Fig. 9During the red blood cell recovery phase, air from the plasma collection container 48 (which was delivered thereto during the blood priming phase) is used to recover the contents of the processing chamber 52 (which may be primarily RBCs) to reduce product losses.

[0075] In the illustrated embodiment, the whole blood pump 16 is deactivated and the plasma pump 18 is operated in the opposite direction (relative to the direction of operation of the plasma pump 18 until this stage of the procedure). This draws air out of the plasma collection container 48 and into line L7. The valve 38a is closed and the clamp 24c is opened, thereby directing air through line L7, into and through line L3, and into the processing chamber 52 via the plasma outlet port. As the air flows through the plasma outlet port, the air will enter the processing chamber 52 at the low gravity side. As additional air is introduced into the processing chamber 52, the air will move from the low gravity wall toward the high gravity wall, thereby forcing any liquid contents through the red blood cell outlet port at the high gravity side and into line L4. During this stage, the centrifuge 22 can be operated at a slower rate (e.g., in the range of about 1000 rpm to 2000 rpm) to reduce the risk of air blockage (such as during the blood priming stage).

[0076] Additive pump 20 continues its operation, drawing additive solution from additive solution container 42 and through line L10 to mix with the contents of process chamber 52 flowing through line L4 at the junction of the two lines L4 and L10. The mixture continues to flow into and through line L5. If the valve system is pressed at the end of the collection phase Figure 7 38a, 38b and 38c may remain closed, while valve 38d is opened to direct the mixture into line L11 for leukocyte reduction, as shown in FIG. Fig. 9 On the other hand, if the valve system is pressed at the end of the collection phase Figure 8 In order to arrange the mixture in a configuration as shown in FIG. 1 (so as to bypass the leukocyte reduction filter 62), valves 38a, 38c and 38d can remain closed, while valve 38b is opened to direct the mixture through lines L8 and L13 to bypass the leukocyte reduction filter 62, as shown in FIG. Fig.10 As described above with respect to the collection phase, the controller can change the configuration of the valve system from Fig. 9 The configuration shown is changed to Fig.10 configured to stop leukoreduction of the mixture (e.g., if the pressure of the leukoreduction filter 62 becomes too great).

[0077] Regardless of whether the mixture is filtered or not, the mixture flows into line L12, through the open clamp 24b, and into the red blood cell collection container 46. The red blood cell recovery phase continues until all air is removed from the plasma collection container 48. In an exemplary embodiment, the weight of the plasma collection container 48 can be monitored by a scale, wherein an empty plasma collection container 48 is detected when the weight is at or below a threshold. Other methods can also be used to determine when to end the red blood cell recovery phase, such as using an optical sensor 34 to detect plasma flowing through line L3.

[0078] Once the red blood cell recovery phase is complete, the procedure will transition to the "additive solution flush" phase. During the additive solution flush phase, additive solution from additive solution container 42 is transferred to red blood cell collection container 46 until a target amount of additive solution is in red blood cell collection container 46. The only change in transitioning from the red blood cell recovery phase to the additive solution flush phase involves deactivating the plasma pump (and closing clamp 24c) to prevent plasma from being removed from plasma collection container 48 (although additive pump 20 may also be operated at a different rate). Therefore, if the valve system is arranged to direct flow through leukoreduction filter 62 (e.g., at the end of the red blood cell recovery phase) at the end of the red blood cell recovery phase, the leukoreduction filter 62 will be closed. Fig. 9 ), the additive solution rinse phase will be as follows Fig.11 On the other hand, if the valve system is arranged to bypass the leukocyte reduction filter 62 (such as Fig.10 ), the additive solution rinse phase will be as follows Fig.12 If the additive solution is pumped through the leukocyte reduction filter 62 (eg, Fig.11 ), the additive solution flowing through line L11 will flush the residual red blood cells in the leukocyte reduction filter 62 into the red blood cell collection container 46 (in addition to the appropriate volume of additive solution to obtain the RBC product).

[0079] The additive solution flushing phase will continue until the target amount of additive solution is added to the red blood cell collection container 46. In an exemplary embodiment, the weight of the additive solution container 42 may be monitored by a scale, wherein a specific change in weight corresponds to the target amount of additive solution that has been delivered to the red blood cell collection container 46. Alternatively (or additionally), the weight of the red blood cell collection container 46 may be monitored by a scale, wherein a specific change in weight corresponds to the target amount of additive solution that has been delivered to the red blood cell collection container 46.

[0080] When the additive solution flushing phase is complete, the system can proceed in one of two ways. If the red blood cells are to be left in the (non-DEHP) red blood cell collection container 46, the system can transition to the "air evacuation" phase, in which the red blood cell collection container 46 is "burped" to remove all residual air for storage (just as air is removed from the plasma collection container 48 during the red blood cell recovery phase). This is accomplished by reversing the direction of operation of the additive pump 20, closing valve 38d (if not already closed at the end of the additive solution flushing phase), and opening valve 38b (if not already opened at the end of the additive solution flushing phase). The additive pump 20 draws air out of the red blood cell collection container 46, through line L12 and the open clamp 24b, into line L13 and through the open valve 38b. The air continues through line L8, line L5, and line L10, and the air is ultimately in the additive solution container 42. Alternatively, rather than evacuating air from the red blood cell collection container 46 into the additive solution container 42, it is within the scope of the present disclosure to direct all or a portion of the air to a different location in the fluid flow circuit 12 (e.g., into the processing chamber 52 and / or into the whole blood container 44, if provided).

[0081] The air evacuation phase will continue until all of the air is removed from the red blood cell collection container 46, which can be determined, for example, by detecting a change in weight of the red blood cell collection container 46 (eg, using a scale).

[0082] On the other hand, it is also within the scope of the present disclosure to store the red blood cells in a container other than the red blood cell collection container 46 at the end of the procedure. In this case, the controller of the processing device 10 can execute a "red blood cell transfer" phase instead of executing an air evacuation phase, such as Fig.13 During the illustrated red blood cell transfer phase, the RBCs in the red blood cell collection container 46 are transferred to the (non-DEHP) whole blood container 44 for collection and storage. This phase may be performed whether the red blood cell collection container 46 is formed of a material that does not contain DEHP or a material that contains DEHP, although this may be particularly advantageous when the red blood cell collection container 46 is formed of a material that contains DEHF.

[0083] As explained above, containers containing additives are not compatible with radiation sterilization. Since the whole blood container 44 contains an anticoagulant solution, the whole blood container 44 may not be sterilized by radiation, so that the whole blood container must be arranged to be separated from the rest of the associated fluid flow circuit (the rest is sterilized via radiation) and sterilized separately (e.g., using steam). Once the whole blood container 44 is sterilized, the whole blood container 44 is aseptically connected to one of the conduits of the fluid flow circuit before using the fluid flow circuit.

[0084] As also explained above, containers formed of materials that do not contain DEHP (e.g., citrate plasticized materials) are also incompatible with radiation sterilization and therefore also require aseptic connection to an associated fluid flow circuit after sterilization. Therefore, when a fluid flow circuit is provided with a non-DEHP red blood cell collection container and a whole blood container containing an anticoagulant solution, both containers need to be aseptically connected to the remainder of the fluid flow circuit, which increases the time and cost of any blood separation procedure. On the other hand, if the procedure ends with the RBC product being in a non-DEHP whole blood container 44, only one aseptic connection (the aseptic connection of the non-DEHP whole blood container 44) is required because the red blood cell collection container 46 (which can be formed of a material including DEHP) can be pre-attached to the fluid flow circuit 12 and radiation sterilized together with the fluid flow circuit 12. It should be clear that this reduces the time and cost of performing a blood separation procedure.

[0085] During the red blood cell transfer phase, the operation of the additive pump 20 is stopped, and the whole blood pump 16 is operated in the opposite direction (compared to the operation direction of the whole blood pump 16 during the previous phase). At this time, the clamp 24a and valve 38f are also opened. Valve 38d is closed (if it has not been closed at the end of the additive solution flushing phase) and valve 38b is opened (if it has not been opened at the end of the additive solution flushing phase). The whole blood pump 16 aspirates the RBC product from the red blood cell collection container 46, through the pipeline L12 and the opened clamp 24b, into the pipeline L13 and through the open valve 38b. Valves 38a and valves 38c remain closed, so that the RBC product continues to pass through the pipeline L8 and the pipeline L5. Since the additive pump 20 is not working and the valve 38e remains closed, the RBC product flows from the pipeline L5 into the pipeline L14 and passes through the open valve 38f, and the RBC product eventually flows through the pipeline L1 (and the open clamp 24a) and is finally in the whole blood container 44.

[0086] The red blood cell transfer phase will continue until all of the RBC product (or at least a target amount of the RBC product) is removed from the red blood cell collection container 46, which can be determined by detecting a change in weight of the red blood cell collection container 46 (e.g., using a scale). Fig.13The system state illustrated in the figure may continue after the red blood cell product in the red blood cell collection container 46 is emptied so that a certain amount of air is aspirated from the red blood cell collection container 46. This can be considered an alternative "air pump-down" stage, because air is being removed from the red blood cell collection container 46 for more complete transfer of the RBC product to the whole blood container 44, rather than for improving the storage of the RBC product in the red blood cell collection container 46 (as in the air pump-down stage described above). More specifically, during this alternative air pump-down stage, air from the red blood cell container 46 follows the same path as the RBC product through the fluid flow circuit 12, thereby flushing any residual red blood cell product from that path into the whole blood container 44 and ensuring that the red blood cell product is more completely collected.

[0087] After completing the air evacuation phase or the red blood cell transfer phase or the alternative air evacuation phase, any of a number of post-processing phases may be performed. For example, Fig.14 A "sealing" stage is shown, in which all clamps and valves are closed and all pumps are deactivated. In the illustrated embodiment (in which the RBC product is stored in the whole blood container 44), the line L1 connected to the whole blood container 44 and the line L7 connected to the plasma collection container 48 are sealed and optionally cut off for storing the RBC product and the plasma product. Alternatively, if the RBC product is to be stored in the red blood cell collection container 46, the line L12 connected to the red blood cell collection container 46 (rather than the line L1 connected to the whole blood container 44) can be sealed and optionally cut off for storing the RBC product.

[0088] For any severed lines, the associated container may be stored, while the remainder of the fluid flow loop 12 is discarded. The lines may be sealed (and optionally severed) according to any suitable method, for example, suitable methods may include sealing with an RF sealant in conjunction with or associated with a suitable clamp. In another embodiment, the fluid flow loop 12 may be removed from the processing device 10, wherein the appropriate lines are sealed (and optionally severed) using a dedicated sealing device.

[0089] All aspects

[0090] Aspect 1. A blood processing system, comprising: a reusable processing device, the processing device comprising a pump system, a blood separation component, and a controller configured to perform a blood processing procedure; and a disposable fluid flow circuit, the fluid flow circuit comprising a processing chamber received by the blood separation component, a red blood cell collection container containing an additive solution, an additive solution container, and a plurality of conduits fluidly connecting components of the fluid flow circuit, wherein the controller is configured to actuate the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container, actuate the pump system to transfer blood from a blood source to the processing chamber, actuate the blood separation component to separate red blood cells from the blood in the processing chamber, actuate the pump system to transfer at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and actuate the pump system to transfer at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0091] Aspect 2. The blood processing system of aspect 1, wherein the additive solution container is substantially empty before the controller actuates the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container.

[0092] Aspect 3. The blood processing system according to any one of the preceding aspects, wherein the red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0093] Aspect 4. The blood processing system according to any one of the preceding aspects, wherein the additive solution container is formed of a material containing di-2-ethylhexyl phthalate.

[0094] Aspect 5. The blood processing system according to any one of the preceding aspects, wherein the red blood cell collection container is formed of a material comprising a citrate plasticizer.

[0095] Aspect 6. The blood processing system according to any one of the preceding aspects, wherein the red blood cell collection container is disposed separately from the fluid flow circuit and is configured to be aseptically connected to one of the conduits of the fluid flow circuit.

[0096] Aspect 7. The blood processing system according to any one of the preceding aspects, wherein the additive solution container is pre-attached to one of the conduits of the fluid flow circuit.

[0097] Aspect 8. The blood processing system according to any one of the preceding aspects, wherein the controller is configured to execute the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in the red blood cell collection container at the end of the blood processing procedure.

[0098] Aspect 9. The blood processing system according to any one of Aspects 1 to 7, wherein the controller is configured to perform the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in a container other than the red blood cell collection container at the end of the blood processing procedure.

[0099] Aspect 10. The blood processing system of Aspect 9, wherein the blood source comprises a whole blood container, and the controller is configured to perform the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in the whole blood container at the end of the blood processing procedure.

[0100] Aspect 11. A method for separating red blood cells from whole blood, the method comprising: transferring an additive solution from a red blood cell collection container to an additive solution container; transferring blood from a blood source to a processing chamber; separating red blood cells from the blood in the processing chamber; transferring at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container; and transferring at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0101] Aspect 12. The method of aspect 11, wherein the additive solution container is substantially empty prior to transferring the additive solution from the red blood cell collection container to the additive solution container.

[0102] Aspect 13. The method according to any one of aspects 11 to 12, wherein the red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0103] Aspect 14. The method according to any one of aspects 11 to 13, wherein the additive solution container is formed of a material containing di-2-ethylhexyl phthalate.

[0104] Aspect 15. The method according to any one of aspects 11 to 14, wherein the red blood cell collection container is formed of a material comprising a citrate plasticizer.

[0105] Aspect 16. The method according to any one of aspects 11 to 15, further comprising aseptically connecting the red blood cell collection container to a fluid flow circuit including the processing chamber.

[0106] Aspect 17. The method according to any one of aspects 11 to 16, wherein the additive solution container is pre-attached to a fluid flow circuit including the process chamber.

[0107] Aspect 18. The method according to any one of aspects 11 to 17, wherein the method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in the red blood cell collection container.

[0108] Aspect 19. The method according to any one of aspects 11 to 17, wherein the method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in a container other than the red blood cell collection container.

[0109] Aspect 20. The method of aspect 19, wherein the blood source comprises a whole blood container and the method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in the whole blood container.

[0110] Aspect 21. A blood processing system, comprising: a reusable processing device, the processing device including a pump system, a blood separation component and a controller configured to perform a blood processing procedure; and a disposable fluid flow circuit, the fluid flow circuit including a processing chamber received by the blood separation component, a red blood cell collection container, a whole blood container and a plurality of conduits fluidly connecting the components of the fluid flow circuit, wherein the controller is configured to actuate the pump system to transfer an additive solution from the red blood cell collection container to the additive solution container, actuate the pump system to transfer blood from the whole blood container to the processing chamber, actuate the blood separation component to separate red blood cells from the blood in the processing chamber, actuate the pump system to transfer at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and actuate the pump system to transfer the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0111] Aspect 22. The blood processing system according to Aspect 21, wherein the red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate.

[0112] Aspect 23. The blood processing system according to Aspect 21, wherein the red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0113] Aspect 24. The blood processing system according to any one of aspects 21 to 23, wherein the whole blood container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0114] Aspect 25. The blood processing system according to any one of Aspects 21 to 24, wherein the blood separation assembly is configured as a centrifuge.

[0115] Aspect 26. The blood processing system according to any one of Aspects 21 to 25, wherein the controller is further configured to actuate the pump system to deliver a certain amount of air from the red blood cell collection container after delivering the at least a portion of the separated red blood cells from the red blood cell collector to the whole blood container.

[0116] Aspect 27. A blood processing system according to any one of Aspects 21 to 26, wherein the fluid flow circuit includes an additive solution container, and the controller is configured to actuate the pump system to transfer the additive solution from the additive solution container to the red blood cell collection container before actuating the pump system to transfer the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0117] Aspect 28. The blood processing system of Aspect 27, wherein the additive solution container is substantially empty before the controller actuates the pump system to transfer blood from the whole blood container to the processing chamber.

[0118] Aspect 29. A blood processing system according to any one of Aspects 27 to 28, wherein the red blood cell collection container initially contains the additive solution, and the controller is configured to actuate the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container before actuating the pump system to transfer blood from the whole blood container to the processing chamber.

[0119] Aspect 30. The blood processing system according to any one of Aspects 27 to 29, wherein the additive solution container is formed of a material comprising di-2-ethylhexyl phthalate.

[0120] Aspect 31. A method for separating red blood cells from whole blood, the method comprising: transferring blood from a whole blood container to a processing chamber; separating red blood cells from the blood in the processing chamber; transferring at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container; and transferring the at least a portion of the separated red blood cells out of the red blood cell collection container and into the whole blood container.

[0121] Aspect 32. The method according to aspect 31, wherein the red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate.

[0122] Aspect 33. The method according to aspect 31, wherein the red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0123] Aspect 34. The method according to any one of aspects 31 to 33, wherein the whole blood container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0124] Aspect 35. The method according to any one of aspects 31 to 34, wherein separating red blood cells from the blood in the processing chamber comprises separating the red blood cells from the blood via centrifugation.

[0125] Aspect 36. The method according to any one of aspects 31 to 35, further comprising transferring a certain amount of air from the red blood cell collection container after transferring the at least a portion of the separated red blood cells from the red blood cell collector to the whole blood container.

[0126] Aspect 37. The method according to any one of Aspects 31 to 36, further comprising transferring an additive solution from the additive solution container to the red blood cell collection container before transferring the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0127] Aspect 38. The method of aspect 37, wherein the additive solution container is substantially empty prior to transferring the blood from the whole blood container to the processing chamber.

[0128] Aspect 39. The method according to any one of Aspects 37 to 38, wherein the red blood cell collection container initially contains the additive solution, and the method comprises transferring the additive solution from the red blood cell collection container to the additive solution container before transferring the blood from the whole blood container to the processing chamber.

[0129] Aspect 40. The method of any one of aspects 37 to 39, wherein the additive solution container is formed of a material comprising di-2-ethylhexyl phthalate.

[0130] It will be appreciated that the embodiments and examples described above illustrate some of the applications of the principles of the present subject matter. Without departing from the spirit and scope of the claimed subject matter, many modifications may be made by those skilled in the art, including combinations of features that are disclosed or claimed separately herein. For these reasons, the scope of the present invention is not limited to the above description but as described in the appended claims, and it should be understood that these claims may be directed to features of the present invention, including combinations of features that are disclosed or claimed separately herein.

Claims

1. A blood treatment system, comprising: A reusable processing device comprising Pump systems, Blood separation components, and a controller configured to execute a blood processing program; as well as A disposable fluid flow circuit, the fluid flow circuit comprising a processing chamber received by the blood separation assembly, a red blood cell collection container, the red blood cell collection container comprising an additive solution, an additive solution container, and a plurality of conduits fluidly connecting components of the fluid flow circuit, wherein the controller is configured to actuating the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container, actuating the pump system to deliver blood from a blood source to the processing chamber, actuating the blood separation assembly to separate red blood cells from the blood in the processing chamber, actuating the pump system to transport at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and The pump system is actuated to transfer at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

2. The blood processing system according to claim 1, wherein: The additive solution container is substantially empty before the controller actuates the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container.

3. A blood treatment system according to any one of the preceding claims, wherein: The red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

4. A blood treatment system according to any one of the preceding claims, wherein: The additive solution container is formed of a material including di-2-ethylhexyl phthalate.

5. A blood treatment system according to any one of the preceding claims, wherein: The red blood cell collection container is formed of a material comprising a citrate plasticizer.

6. A blood treatment system according to any one of the preceding claims, wherein: The red blood cell collection container is disposed separately from the fluid flow circuit and is configured to be aseptically connected to one of the conduits of the fluid flow circuit.

7. A blood treatment system according to any one of the preceding claims, wherein: The additive solution container is pre-attached to one of the conduits of the fluid flow circuit.

8. A blood treatment system according to any one of the preceding claims, wherein: The controller is configured to execute the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in the red blood cell collection container at the end of the blood processing procedure.

9. The blood processing system according to any one of claims 1 to 7, wherein: The controller is configured to execute the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in a container other than the red blood cell collection container at the end of the blood processing procedure.

10. The blood processing system according to claim 9, wherein The blood source includes a container of whole blood, and The controller is configured to execute the blood processing procedure so that at least a portion of the separated red blood cells and at least a portion of the additive solution remain in the whole blood container at the end of the blood processing procedure.

11. A method for separating red blood cells from whole blood, the method comprising: transferring an additive solution from the red blood cell collection container to an additive solution container; transporting blood from a blood source to a processing chamber; separating red blood cells from the blood in the processing chamber; transporting at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container; as well as At least a portion of the additive solution is transferred from the additive solution container to the red blood cell collection container.

12. The method according to claim 11, wherein: Prior to transferring the additive solution from the red blood cell collection container into the additive solution container, the additive solution container is substantially empty.

13. The method according to any one of claims 11 to 12, wherein: The red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

14. The method according to any one of claims 11 to 13, wherein: The additive solution container is formed of a material including di-2-ethylhexyl phthalate.

15. The method according to any one of claims 11 to 14, wherein: The red blood cell collection container is formed of a material comprising a citrate plasticizer.

16. The method of any one of claims 11 to 15, further comprising aseptically connecting the red blood cell collection container to a fluid flow circuit including the processing chamber.

17. The method according to any one of claims 11 to 16, wherein: The additive solution container is pre-attached to a fluid flow circuit including the process chamber.

18. The method according to any one of claims 11 to 17, wherein: The method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in the red blood cell collection container.

19. The method according to any one of claims 11 to 17, wherein: The method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in a container other than the red blood cell collection container.

20. The method according to claim 19, wherein The blood source includes a container of whole blood, and The method ends with the at least a portion of the separated red blood cells and the at least a portion of the additive solution being in the whole blood container.

21. A blood processing system, comprising: A reusable processing device comprising Pump systems, Blood separation components, and a controller configured to execute a blood processing program; as well as A disposable fluid flow circuit, the fluid flow circuit comprising a processing chamber received by the blood separation assembly, Red blood cell collection container, Whole blood container, and a plurality of conduits fluidly connecting components of the fluid flow circuit, wherein the controller is configured to actuating the pump system to transfer blood from the whole blood container to the processing chamber, actuating the blood separation assembly to separate red blood cells from the blood in the processing chamber, actuating the pump system to transport at least a portion of the separated red blood cells out of the processing chamber and into the red blood cell collection container, and The pump system is actuated to transfer the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

22. The blood processing system according to claim 21, wherein: The red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate.

23. The blood processing system according to claim 21, wherein: The red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

24. A blood processing system according to any one of claims 21 to 23, wherein: The whole blood container is formed of a material that does not contain di-2-ethylhexyl phthalate.

25. A blood processing system according to any one of claims 21 to 24, wherein: The blood separation component is configured as a centrifuge.

26. A blood processing system according to any one of claims 21 to 25, wherein: The controller is further configured to actuate the pump system to deliver a certain amount of air from the red blood cell collection container after delivering the at least a portion of the separated red blood cells from the red blood cell collector to the whole blood container.

27. A blood processing system according to any one of claims 21 to 26, wherein The fluid flow circuit includes an additive solution container, and The controller is configured to actuate the pump system to transfer an additive solution from the additive solution container to the red blood cell collection container before actuating the pump system to transfer the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

28. The blood processing system according to claim 27, wherein: The additive solution container is substantially empty before the controller actuates the pump system to transfer blood from the whole blood container into the processing chamber.

29. A blood processing system according to any one of claims 27 to 28, wherein The red blood cell collection container initially contains the additive solution, and The controller is configured to actuate the pump system to transfer the additive solution from the red blood cell collection container to the additive solution container before actuating the pump system to transfer blood from the whole blood container to the processing chamber.

30. A blood processing system according to any one of claims 27 to 29, wherein: The additive solution container is formed of a material including di-2-ethylhexyl phthalate.

31. A method for separating red blood cells from whole blood, the method comprising: transferring blood from a whole blood container to a processing chamber; separating red blood cells from the blood in the processing chamber; transporting at least a portion of the separated red blood cells out of the processing chamber and into a red blood cell collection container; and The at least a portion of the separated red blood cells are transported out of the red blood cell collection container and into the whole blood container.

32. The method according to claim 31, wherein: The red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate.

33. The method according to claim 31, wherein: The red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

34. The method according to any one of claims 31 to 33, wherein: The whole blood container is formed of a material that does not contain di-2-ethylhexyl phthalate.

35. The method according to any one of claims 31 to 34, wherein: The separating of red blood cells from the blood in the processing chamber includes separating the red blood cells from the blood via centrifugation.

36. The method according to any one of claims 31 to 35, further comprising transferring a certain amount of air from the red blood cell collection container after transferring the at least a portion of the separated red blood cells from the red blood cell collector to the whole blood container.

37. The method according to any one of claims 31 to 36, further comprising transferring an additive solution from an additive solution container to the red blood cell collection container before transferring the at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

38. The method of claim 37, wherein: Prior to transferring the blood from the whole blood container into the processing chamber, the additive solution container is substantially empty.

39. The method according to any one of claims 37 to 38, wherein The red blood cell collection container initially contains the additive solution, and The method includes transferring the additive solution from the red blood cell collection container to the additive solution container prior to transferring the blood from the whole blood container to the processing chamber.

40. The method according to any one of claims 37 to 39, wherein: The additive solution container is formed of a material including di-2-ethylhexyl phthalate.

Images