Management of red blood cell addition solution and storage of red blood cell preparations

Abstract

The blood treatment system includes durable hardware components and disposable fluid flow circuits. The hardware components include a control unit configured to perform procedures for separating and collecting red blood cells from whole blood. An additive solution can first be provided in the red blood cell collection container of the fluid flow circuit, and the control unit operates the pump system of the hardware components to convey the additive solution from the red blood cell collection container to the additive solution container of the fluid flow circuit. After the red blood cells are separated from the blood and conveyed to the red blood cell collection container (along with at least a portion of the additive solution from the additive solution container), the red blood cells and the additive solution in the red blood cell collection container are conveyed to the whole blood container for collection and storage.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 347,382, filed on May 31, 2022, the content of which is incorporated herein by reference.

[0002] [Technical Field] The present disclosure generally relates to the separation and collection of red blood cells ( "RBCs") from blood. More specifically, the present disclosure relates to devices and methods for managing red blood cell additive solutions and / or storing red blood cell products using one or more containers that do not contain di - 2 - ethylhexyl phthalate ( "DEHP").

Background Art

[0003] Blood and blood components are widely used in medical applications, and typically, whole blood collected from donors is further processed. In many cases, blood is processed to extract blood components such as red blood cells, plasma, platelets, etc. This can be done, for example, by collecting whole blood, subsequently filtering it, and then centrifuging it, or by collecting whole blood, subsequently centrifuging it, and then filtering it, or by automated collection of components.

[0004] Red blood cells are separated from the collected whole blood and are then often transfused to patients who need them. For example, red blood cells may be administered to patients suffering from blood loss due to trauma, as a treatment after chemotherapy, or as part of the treatment of one or more blood infections. Unless administered immediately after collection and separation, red blood cells are usually stored for a certain period of time before transfusion. The storage period varies from a few days to several weeks.

[0005] For the collection, processing, storage, and transfusion of blood and blood components, plasticized polyvinyl chloride (''PVC'')-based materials and solutions are commonly used. Due to its properties, PVC is very suitable for these applications, especially for use in transfusion systems. However, since PVC is very brittle, it is used together with plasticizers or extractants to ensure the flexibility and softness required for the material. Therefore, ortho-phthalic acid esters such as DEHP (hereinafter also referred to as ''phthalic acid esters'') are usually used as plasticizers or extractants for PVC.

[0006] DEHP is an effective plasticizer or extractant for PVC, but leaching of DEHP from the containers of the extracorporeal fluid flow circuit into the (biological or non-biological) fluid stored therein can occur. DEHP has been found to improve the quality of red blood cells during storage (by reducing hemolysis). However, due to the high potential for interaction, certain recipients of blood or blood components (such as pregnant women and newborns) are considered to be particularly sensitive to DEHP (and the potential for adverse health effects). Therefore, while leaching of the DEHP plasticizer from used materials can potentially have a beneficial effect on the quality of blood components, there is an increasing need to provide blood and blood components that are essentially DEHP-free (or more preferably essentially phthalic acid ester-free) to the individuals who need them.

SUMMARY OF THE INVENTION

[0007] The subject matter of the present invention has several aspects 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 preclude the use of these aspects separately or the claiming of these aspects separately or in different combinations as set forth in the claims appended hereto.

[0008] In one aspect, a blood treatment system includes a reusable treatment device and a disposable fluid flow circuit. The treatment device includes a pump system, a blood separation assembly, and a control unit configured to execute a blood treatment procedure. The disposable fluid flow circuit has a treatment chamber received by the blood separation assembly, a red blood cell collection container containing an additive solution, an additive solution container, and a plurality of conduits fluidly connecting the components of the fluid flow circuit. The control unit is configured to operate the pump system to convey the additive solution from the red blood cell collection container to the additive solution container, operate the pump system to convey blood from a blood source to the treatment chamber, and operate the blood separation assembly to separate red blood cells from the blood in the treatment chamber. Next, the control unit operates the pump system to convey at least a portion of the separated red blood cells from the treatment chamber to the red blood cell collection container and operates the pump system to convey at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0009] In another aspect, a method for separating red blood cells from whole blood is provided. The method includes conveying an additive solution from a red blood cell collection container to an additive solution container, conveying blood from a blood source to a treatment chamber, and then separating red blood cells from the blood in the treatment chamber. At least a portion of the separated red blood cells is conveyed from the treatment chamber to the red blood cell collection container and at least a portion of the additive solution is conveyed from the additive solution container to the red blood cell collection container.

[0010] In yet another aspect, a blood treatment system includes a reusable treatment device and a disposable fluid flow circuit. The treatment device has a pump system, a blood separation assembly, and a control unit configured to perform a blood treatment procedure. The fluid flow circuit has a treatment chamber contained by the blood separation assembly, a red blood cell collection container, a whole blood container, and a plurality of conduits fluidly connecting the components of the fluid flow circuit. The control unit is configured to operate the pump system to transfer blood from the whole blood container to the treatment chamber and then operate the blood separation assembly to separate red blood cells from the blood in the treatment chamber. The control unit then operates the pump system to convey at least a portion of the separated red blood cells from the treatment chamber to the red blood cell collection container and then operates the pump system to convey at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0011] In another aspect, a method for separating red blood cells from whole blood is provided. The method includes conveying blood from a whole blood container to a treatment chamber and then separating red blood cells from the blood in the treatment chamber. Next, at least a portion of the separated red blood cells is conveyed from the treatment chamber to a red blood cell collection container and then the at least a portion of the separated red blood cells is conveyed from the red blood cell collection container to the whole blood container.

[0012] These and other aspects of the invention are set forth in the following detailed description of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 is a perspective view of an exemplary reusable hardware component of a blood treatment system configured to receive a disposable fluid flow circuit.

[0014] FIG. 2 is a plan view of an exemplary disposable fluid flow circuit used in combination with the durable hardware component of FIG. 1.

[0015] FIG. 3 is a schematic view of the fluid flow circuit of FIG. 2 attached to the treatment device of FIG. 1 to complete a blood treatment system according to one aspect of the present disclosure.

[0016] Figure 4 is a schematic diagram of the blood treatment system of FIG. 3 that executes the "additive solution transfer" stage of an exemplary blood treatment procedure.

[0017] Figure 5 is a schematic diagram of the blood treatment system of FIG. 3 that executes the "blood priming" stage of an exemplary blood treatment procedure.

[0018] Figure 6 is a schematic diagram showing the state in which the blood treatment system of FIG. 3 is executing the "separation establishment" stage of an exemplary blood treatment procedure.

[0019] Figure 7 is a schematic diagram showing the state in which the blood treatment system of FIG. 3 is executing the "collection" stage of an exemplary blood treatment procedure. The separated red blood cells have reduced white blood cells before collection.

[0020] Figure 8 is a schematic diagram showing a modification of the "collection" stage of FIG. 7. The separated red blood cells have not had their white blood cells reduced before collection.

[0021] Figure 9 is a schematic diagram showing the state in which the blood treatment system of FIG. 3 is executing the "red blood cell collection" stage of an exemplary blood treatment procedure. The separated red blood cells have reduced white blood cells before collection.

[0022] Figure 10 is a schematic diagram of a modification of the "red blood cell collection" stage of FIG. 9, and the separated red blood cells have not had their white blood cells reduced before collection.

[0023] Figure 11 is a schematic diagram of the blood treatment system of FIG. 3 executing the "additive solution flush" stage of an exemplary blood treatment procedure, and the additive solution passes through a leukocyte reduction filter before entering the red blood cell collection container.

[0024] Figure 12 is a schematic diagram of a modification of the "additive solution flush" stage of FIG. 11, and the additive solution enters the red blood cell collection container without passing through a leukocyte reduction filter.

[0025] FIG. 13 is a schematic diagram showing the blood treatment system of FIG. 3 performing the "erythrocyte transfer" and "air discharge" steps of an exemplary blood treatment procedure.

[0026] FIG. 14 is a schematic diagram showing the blood treatment system of FIG. 3 performing the "sealing" step of an exemplary blood treatment procedure.

DETAILED DESCRIPTION OF THE INVENTION

[0027] The embodiments disclosed herein are for the purpose of explaining the subject matter of the present invention, and it is understood that the subject matter of the present invention can be implemented in various other forms and combinations that are not shown in detail. Therefore, the specific designs and features disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0028] The embodiments disclosed herein are intended to provide an exemplary description of the subject matter of the present invention. However, these are merely exemplary and not exclusive, and the subject matter of the present invention can be implemented in various forms. Therefore, the specific details disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0029] FIG. 1 shows the reusable or durable hardware components or processing devices (generally designated by reference numeral 10) of a configurable automated blood treatment system or blood component manufacturing system, while FIG. 2 shows the disposable or single-use fluid flow circuit (generally designated by reference numeral 12) used in combination with the processing device 10 to process the collected whole blood. The illustrated processing device 10 and fluid flow circuit 12 are generally configured as described in PCT International Publication No. WO2021 / 194824A1, which is incorporated herein by reference, but it should be understood that the processing device 10 and the associated fluid flow circuit 12 may have different configurations without departing from the scope of the present disclosure.

[0030] The illustrated processing device 10 includes associated pumps, valves, sensors, display units, and other devices for setting and controlling the flow of fluid through the fluid flow circuit 12, which will be described in detail below. The blood processing system may be controlled by a control unit integrated with the processing device 10 that includes a programmable microprocessor for automatically controlling the operation of pumps, valves, sensors, etc. The processing device 10 may also include a wireless communication function that enables data transfer from the processing device 10 to the operator's quality control system.

[0031] More specifically, the illustrated processing device 10 includes a pump station or system that includes a user input and output touch screen 14, 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 an additive solution), a centrifuge attachment station and drive unit 22 (sometimes referred to herein as a "centrifuge"), and clamps 24a - c. Although blood separation is described herein as being achieved by centrifugation, it should be understood that the present disclosure is not limited to blood separation by centrifugation, but rather encompasses any suitable approach and blood separation assembly for separating blood into two or more components. For example, in one embodiment, the centrifuge may be replaced by a rotary membrane type blood separation assembly of the type described in U.S. Patent Application Publication No. 2019 / 0201916, which is incorporated herein by reference.

[0032] With the touch screen 14, the user can interact with the processing device 10 and also monitor procedural parameters such as flow rate, container weight, pressure, etc. Pumps 16, 18, and 20 (collectively referred to herein as part of the "pump system" of the processing device 10) are shown as peristaltic pumps that can receive a tube or conduit and move fluid at various speeds through associated conduits according to the procedure being executed. An example of a centrifuge attachment station / drive unit is described in U.S. Patent No. 8,075,468, incorporated herein by reference (see Figures 26 - 28). Clamps 24a - c (collectively referred to herein as part of the "valve system" of the processing device 10) can open and close the fluid path through a tube or conduit, perform a thermal seal on the tube or conduit disposed within the clamp, and can incorporate an RF sealer to seal the tube or conduit leading to the product container upon completion of the procedure.

[0033] One or more of the clamps 24a - c can also incorporate a sterile connection / docking device. The sterile connection device can employ any of several different operating principles. For example, known sterile connection devices and systems include a radiant energy system that melts opposing membranes of a fluid flow conduit, such as in U.S. Patent No. 4,157,723; a heated wafer system that uses a wafer to cut and thermally bond or join tube segments with their ends in a melted or semi - melted state, such as in U.S. Patents Nos. 4,753,697, 5,158,630, and 5,156,701; and a system that uses a removable closure film or web sealed to the ends of tube segments, as described in U.S. Patent No. 10,307,582. Alternatively, a sterile connection can be formed by compressing or pinching a sealed tube segment, heating and cutting the sealed end, and joining the tube to a similarly processed tube segment (see, for example, U.S. Patents Nos. 10,040,247 and 9,440,396). All of the above patents are incorporated herein by reference in their entirety. Without departing from the scope of the present disclosure, sterile connection devices based on other operating principles can also be used.

[0034] The processing device 10 also includes hoists 26a to d (which may each be associated with a weighing scale) for suspending various containers of the disposable fluid circuit 12. The hoists 26a to d are preferably attached to a support 28 that is movable in the vertical direction to improve the transportability of the processing device 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 the interface between the blood components separated within 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 for optically monitoring one or more conduits entering and exiting the centrifuge 22.

[0035] The surface of the processing device 10 includes a nesting module 36 for mounting a flow control cassette 50 (FIG. 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 and can execute various types of procedures using the system. Embedded within the illustrated cassette nesting module 36 are four valves 38a to f (collectively referred to herein as part of the "valve system" of the processing device 10) for opening and closing the fluid flow paths within the flow control cassette 50, and three pressure sensors 40a to c capable of measuring the pressure at various locations in the fluid flow circuit 12.

[0036] Referring to FIG. 2, the illustrated fluid flow circuit 12 includes a plurality of containers 42, 44, 46, and 48, a flow control cassette 50, and a processing / separation chamber 52 configured to be housed within the centrifuge 22, all of which are interconnected by conduits or tube segments to enable continuous flow centrifugation. The flow control cassette 50 routes the fluid flow through three tube loops 54, 56, 58, each loop being arranged to engage a particular one of the pumps 16, 18, 20. The conduits or tubes may extend through the cassette 50 or the cassette 50 may have pre-formed fluid flow paths that direct the fluid flow.

[0037] In the fluid flow circuit 12 shown in FIG. 2, container 42 is pre-filled with an additive solution, container 44 is filled with whole blood, is connected to the fluid flow circuit 12 during use, container 46 is an empty container for receiving red blood cells separated from whole blood, and container 48 is an empty container for receiving plasma separated from whole blood. FIG. 2 shows a whole blood container 44 (e.g., configured as a blood pack unit) as a blood source, but as will be described in more detail herein, it is also within the scope of the present disclosure for the blood source to be a living donor. Further, although container 42 may be pre-filled with an additive solution, it is also within the scope of the present disclosure for container 42 to be empty and one of the other containers to be pre-filled with an additive solution, and all or part of the additive solution to be conveyed to container 42 during a blood processing procedure (details will be described later). The fluid flow circuit may optionally include an air trap 60 (FIG. 3) through which whole blood flows before entering the processing chamber 52, and / or a leukocyte reduction filter 62 through which RBCs flow before entering the red blood cell collection container 46.

[0038] The processing chamber 52 can be pre-formed into 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 can vary depending on the elements to be separated, and the present disclosure is not limited to the use of a particular chamber design. For example, it is also within the scope of the present disclosure to configure the processing chamber 52 to be formed of a generally flexible material rather than a generally rigid material. When the processing chamber 52 is generally formed of a flexible material, the shape of the processing chamber 52 is defined by the centrifuge 22. Exemplary processing chambers formed of flexible materials and related centrifuges are described in U.S. Patent No. 6,899,666, which is incorporated herein by reference.

[0039] In an exemplary embodiment, the control unit of the processing device 10 is pre-programmed to automatically operate the system to execute one or more standard blood processing procedures selected by an operator via an input to the touch screen 14, and is further configured to be programmed by the operator to execute additional blood processing procedures. The control unit may be pre-programmed to substantially automate a variety of procedures, including, but not limited to, the production of RBCs and plasma from a single unit of whole blood (described in more detail herein), the pooling of buffy coats, the separation of buffy coats into platelet products (described in U.S. Patent Application Publication No. 2018 / 0078582, which is incorporated herein by reference), the addition of glycerol to RBCs, the washing of RBCs, the washing of platelets, and the pooling and separation of cryoprecipitates.

[0040] The pre-programmed blood processing procedures operate the system with pre-set settings of flow rate and centrifugal force, and the programmable control unit may be further configured to receive input from an operator regarding one or more of the flow rate and centrifugal force of the standard blood processing procedures to invalidate the pre-programmed settings.

[0041] Furthermore, the programmable control unit is configured to receive input from an operator via the touch screen 14 and operate the system to execute non-standard blood processing procedures. More specifically, the programmable control unit may be configured to receive input of settings for non-standard blood processing procedures, including flow rate and centrifugal force.

[0042] In an exemplary procedure, the processing device 10 and the fluid flow circuit 12 can be used in combination to process a quantity of whole blood (e.g., one unit) into RBC products and plasma products. FIG. 3 is a schematic diagram of the fluid flow circuit 12 attached to the processing device 10, showing selected components of the fluid flow circuit 12 and selected components of the processing device 10. FIGS. 4-14 show various stages of an exemplary blood processing procedure.

[0043] As described above, whether the additive solution container 42 is pre-filled with the additive solution, or is empty and another container is pre-filled with the additive solution, is within the scope of the present disclosure. 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 an additive solution (e.g., ADSOL (registered trademark)). The advantage of such a configuration is that a DEHP-free plasticized container (i.e., the red blood cell collection container 46) can be used for storing the RBCs generated during the blood separation procedure, while the additive solution container 42 can be formed of a material containing DEHP. Such an approach reduces the time and cost of performing the blood separation procedure as compared to conventional approaches.

[0044] More specifically, the additive solution is generally contained within a dedicated additive solution container. Since a container filled with the additive solution cannot be sterilized by radiation, the additive solution container is provided separately from the rest of the associated fluid flow circuit (which is sterilized by radiation) and needs to be sterilized separately (e.g., using steam). Once the additive solution container is sterilized, it is aseptically connected to one of the conduits of the fluid flow circuit immediately prior to use of the fluid flow circuit.

[0045] Similar to the container filled with the additive solution, a container formed of a DEHP-free material (e.g., a citrate plasticized material) is also not suitable for radiation sterilization, and thus an aseptic connection to the associated fluid flow circuit after sterilization is also required. 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 the additive solution, it is necessary to aseptically connect the two containers to the rest of the fluid flow circuit, increasing the time and cost of the blood separation procedure. On the other hand, if the additive solution is initially provided in the non-DEHP red blood cell collection container 46, an empty additive solution container 42 (which may be formed of a material containing DEHP) can be pre-mounted on the fluid flow circuit 12 and sterilized by radiation, so that only one (aseptic) connection (for the non-DEHP red blood cell collection container 46) is required. As is apparent, this reduces the time and cost of performing the blood separation procedure.

[0046] When a red blood cell collection container 46 filled with an additive solution (which can be formed of a citrate plasticized material or other suitable non-DEHP material) is attached to the remainder of the fluid flow circuit 12, the first step of the blood processing procedure is performed and the additive solution can be conveyed from the red blood cell collection container 46 to the additive solution container 42. When this "additive solution transfer" step (shown in FIG. 4) is completed, the blood processing procedure proceeds as normal.

[0047] During the additive solution transfer step, the additive solution is drawn from the red blood cell collection container 46 via line L12 by the operation of a third pump 20 (which may also be referred to as an "additive pump"). Clamp 24b and valve 38b are open, but the other clamps and valves are closed, and the additive solution flows from line L12 into line L13, into line L8, into line L5, and through line L10 into the additive solution container 42. In FIGS. 4 - 14, it should be understood that the arrows on the containers represent the direction of fluid flow between the container and the conduit connected to the container. For example, line L12 is shown as being connected to the top of the red blood cell collection container 46, and the upward arrow (see FIG. 4) indicates that fluid flows upward out of the red blood cell collection container 46. In contrast, line L10 is shown as being connected to the bottom of the additive solution container 42, and the upward arrow (see FIG. 4) represents the upward fluid flow into the additive solution container 42.

[0048] FIG. 4 shows the additive solution flowing around the leukocyte reduction filter 62, but it is also within the scope of the present disclosure to feed the additive solution into the leukocyte reduction filter 62 (closing valve 38b and opening valve 38d). In either case, the additive solution transfer step continues until all or a specific amount of the additive solution has been transferred from the red blood cell collection container 46 to the additive solution container 42. This can be determined by measuring the weight of either or both of containers 42 and 46, monitoring the operation of the additive pump 20 (to confirm that an appropriate volume of fluid has been transferred from the red blood cell collection container 46), or other suitable means.

[0049] Once the addition solution enters the addition solution container 42 (regardless of whether it is initially supplied there or carried there during the addition solution transfer step), the procedure can proceed to a step herein referred to as the "blood priming" step. In such a step (shown in FIG. 5), selected components of the fluid flow circuit 12 are primed using blood from a blood source. The blood source is shown as the whole blood container 44 in FIG. 5, but could alternatively be a living donor. Thus, it should be understood that the term "whole blood" may refer to blood with or without anticoagulant.

[0050] During the blood priming step, whole blood is drawn from the blood source (the whole blood container 44 in the embodiment of FIG. 5) into the fluid flow circuit 12 via line L1 by the operation of the first pump 16 (sometimes referred to as the "whole blood pump"). Valves 38c and 38f are closed, and the blood passes through the pressure sensor 40c and flows into line L2. The blood then 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 disposed within the centrifuge 22 of the processing device 10.

[0051] The centrifuge 22 may remain stationary during the blood priming step, or may be controlled by the control unit of the processing device 10 to rotate at a low rotational speed (e.g., about 1,000 - 2,000 rpm). It may be advantageous to rotate the centrifuge 22 during the blood priming step to generate sufficient gravitational acceleration such that the air within the processing chamber 52 (including the air already present within the processing chamber 52 and the air that has moved into the processing chamber 52 from lines L1 and / or L2 due to the flow of blood) is pushed towards the low g (radial inner) wall of the processing chamber 52. If the rotational speed of the centrifuge is as high as 4,500 rpm (required for steady-state separation as described later), there is a high likelihood of air blockage (where air becomes trapped and cannot be pushed out of the processing chamber 52, causing the pressure to rise), which may be undesirable.

[0052] Blood entering the processing chamber 52 moves towards the high-g (radial outer) wall of the processing chamber 52, pushing air towards the low-g wall. Since the plasma outlet port of the processing chamber 52 is associated with the low-g wall of the processing chamber 52, most of the air is discharged from the processing chamber 52 via line L3 associated with the plasma outlet port, but some air may also be discharged from the processing chamber 52 via the red blood cell outlet port associated with the high-g wall of the processing chamber 52.

[0053] Valves 38b and 38d are closed, the second pump 18 (sometimes called the "plasma pump") is operating, and the additive pump 20 is not operating. With such an arrangement, the air discharged from the processing chamber 52 via the red blood cell outlet port is guided to line L5 via the associated line L4 and pressure sensor 40b, and further to line L6. Since valve 38a is open, the air flowing through line L6 merges with the air flowing through line L3 (i.e., the air discharged from the processing chamber 52 via the plasma outlet port). The mixed air flows through line L7 and the open clamp 24c to the plasma collection container 48.

[0054] The air flow exiting the processing chamber 52 via any of the outlet ports is monitored by the optical sensor 34, which can determine the optical density of the fluid flowing through the line being monitored and 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 ends the blood priming stage and proceeds 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 stage varies depending on several factors (e.g., the amount of air in the fluid flow circuit 12), but can be on the order of about 50 - 100 mL. The blood priming stage can take about 1 - 2 minutes.

[0055] FIG. 5 shows the fluid flow circuit 12 being primed with blood, but it should be understood that the fluid flow circuit 12 may be primed (if necessary) with a separately provided fluid (e.g., an anticoagulant or saline).

[0056] The next step (shown in FIG. 6) is what is referred to herein as the "establishing separation" step. When non-air fluid is detected in lines L3 and L4, the rotational 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., in the range of about 4,500 - 5,500 rpm). To produce a plasma product with low platelets, it may be advantageous to configure the processing chamber 52 with a plasma outlet port located downstream away from the blood inlet port rather than adjacent to the blood inlet port. With such a configuration, platelets can deposit in a distinct layer (commonly referred to as the "buffy coat") between the plasma and red blood cells before the plasma is removed from the processing chamber 52, and the platelets can be removed from the separated plasma. 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 separation establishment step (described below).

[0057] If the blood source (in the case of a whole blood container) contains only a limited amount of whole blood (e.g., a single unit), or (in the case of a living donor) provides only a limited amount of whole blood (e.g., a single unit), the system needs to operate with a finite fluid volume. To avoid product loss and quality issues, the plasma and red blood cells that are first separated from the blood in the processing chamber 52 and removed from the processing chamber 52 are not sent to their respective collection containers. Instead, they are mixed together to form recombined whole blood and recirculated to the processing chamber 52.

[0058] More specifically, during the separation establishment phase, the separated plasma is discharged from the processing chamber 52 via the plasma outlet port and the associated line L3. At this stage, the clamp 24c is closed, the valve 38a remains open, and the plasma is sent from line L3 to line L6. The separated RBCs are discharged from the processing chamber 52 via the RBC outlet port and the associated line L4. In the illustrated embodiment, since there is no pump associated with line L4, the RBCs are discharged from 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 an alternative embodiment, there may be a pump associated with the RBC 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 RBC outlet line.

[0059] At this stage, the additive pump 20 is inoperative, whereby the RBCs are sent from line L4 to line L5. The plasma flowing through line L6 is mixed with the RBCs flowing through line L5 at the confluence of the two lines L5 and L6 to form recombined whole blood. The valve 38d is closed, and the recombined whole blood is sent to line L8. The valve 38b is also closed, and the recombined whole blood is sent from line L8 to line L9 and passes through the open valve 38c. With the clamp 24a closed, the whole blood pump 16 draws the recombined whole blood from line L9 to line L2 (rather than drawing more blood from the blood source into the fluid flow circuit 12). The recombined blood passes through the air trap 60, the pressure sensor 40a, and the optical sensor 34 and then returns to the processing chamber 52, where it is separated again into plasma and red blood cells.

[0060] The separation establishment phase continues until steady separation is achieved, which may take about 1 to 2 minutes. As used herein, the phrase "steady separation" refers to a state in which the 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 position of the interface can be determined and controlled according to any suitable method, including using an interface detector of the type described in U.S. Patent Application Publication No. 2019 / 0201916.

[0061] Preferably, the steady-state separation is achieved with the interface between the separated components in the processing chamber 52 at the target position. The target position corresponds to the position of the interface at which the separation efficiency is optimized, and the exact position varies depending on several factors (e.g., the hematocrit value of the whole blood). However, in an exemplary embodiment, the target position of the interface may be the position of the interface when about 52% of the thickness or width (radial direction) of the channel defined by the processing chamber 52 is occupied by RBCs. 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 causes more separated plasma to be drawn out of the processing chamber 52 (thereby reducing the thickness of the plasma layer in the processing chamber 52) and the interface to move towards the low-g wall, or decreasing the flow rate causes less plasma to be drawn out of the processing chamber 52 (thereby increasing the thickness of the plasma layer in the processing chamber 52) and the interface to move towards the high-g wall.

[0062] 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, whereby the thickness of the RBC layer in the processing chamber 52 rapidly increases and the interface moves towards the low-g wall. The speed of the plasma pump 18 is gradually decreased as the thickness of the RBC layer increases and the position of the interface approaches the target position. As described above, the target position of the interface may depend on the hematocrit of the whole blood, that is, the speed of the plasma pump 18 that controls the position of the interface may also depend on the hematocrit of the whole blood. In one embodiment, this relationship is expressed as follows.

[0063] Theoretical plasma pump speed = Whole blood pump speed - ((Whole blood hematocrit × Whole blood pump speed) / Hematocrit of separated red blood cells) [Equation 1]

[0064] The hematocrit of whole blood can be measured before the start of the procedure or by the optical sensor 34 during the procedure, while the hematocrit of the separated red blood cells can be determined by the optical sensor 34 monitoring line L4 during the procedure. In practice, when steady separation is achieved with the interface at the target position, the plasma pump speed usually does not remain at the theoretical speed; rather, the plasma pump speed tends to "fluctuate" around the theoretical speed.

[0065] Regardless of the specific method by which the control unit of the processing device 10 executes the separation establishment phase to reach steady separation, when steady separation is established, the control unit ends the separation establishment phase and advances the procedure to the "collection" phase shown in FIG. 7. At the start of the collection phase, the centrifuge 22, the whole blood pump 16, and the plasma pump 18 all continue to operate at the same speeds as at the end of the separation establishment 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 recombining them and recirculating them through the centrifuge 22), and to allow additional blood to be drawn into the fluid flow circuit 12 from the blood source until a target volume of whole blood (e.g., 1 unit) is drawn into the fluid flow circuit 12.

[0066] More specifically, during the collection phase, the valve 38c is closed and the clamp 24a is opened, whereby the whole blood pump 16 further draws blood from the blood source (the whole blood container 44 in the illustrated embodiment, but it could also be a living donor) into line L1. The whole blood pump 16 draws blood from the blood source from line L1 into line L2, and the blood passes through the air trap 60, the pressure sensor 40a, and the optical sensor 34 and then flows 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 monocytes), while the larger white blood cells such as granulocytes may be discharged together with the concentrated red blood cells.

[0067] The separated plasma is discharged from the processing chamber 52 via the plasma outlet port and the associated line L3. The valve 38a is closed, and the plasma is directed from line L3 to line L7, passes through the open clamp 24c, and enters the plasma collection container 48.

[0068] For the separated RBCs, they are discharged from the processing chamber 52 via the red blood cell outlet port and the associated line L4. The additive pump 20 is operated by the control unit to draw the additive solution from the additive solution container 42 via 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, and the mixture flows into the line L5 and continues to pass through the line L5. The mixture is finally sent to the red blood cell collection container 46, but as shown in FIG. 7, it may first be conveyed through the leukocyte reduction filter 62 (if provided). Even when the leukocyte reduction filter 62 is provided, as shown in FIG. 8, 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. It is also within the scope of the present disclosure to pass the mixture through the leukocyte reduction filter 62 at the start of the collection stage, reconfigure the valve system during the collection stage so that the mixture bypasses the leukocyte reduction filter 62, and reduce the leukocytes in only a part of the collected red blood cells.

[0069] In the configuration of FIG. 7 (where the mixture is leukocyte-reduced), the valves 38a, 38b, and 38c are closed, the valve 38d is opened, and the mixture is sent from the line L5 to the line L11. The mixture passes through the open valve 38d and the leukocyte reduction filter 62 and flows into the line L12. Next, the leukocyte-reduced mixture passes through the open clamp 24b and flows into the red blood cell collection container 46.

[0070] In the configuration of FIG. 8 (where the mixture is not leukocyte-reduced), the valves 38a, 38c, and 38d are closed, the valve 38b is open, and the mixture is sent from the line L5 to the line L8 and then to the line L13. The mixture passes through the open valve 38b and flows into the line L12, bypassing the leukocyte reduction filter 62. Next, the non-leukocyte-reduced mixture passes through the open clamp 24b and flows into the red blood cell collection container 46.

[0071] As described above, the mixture can be passed through the leukocyte reduction filter 62 at the start of the collection stage (see FIG. 7), but during the collection stage, the valve system is reconfigured so that the mixture bypasses the leukocyte reduction filter 62 (see FIG. 8), and only a portion of the collected red blood cells is leukocyte reduced. In one embodiment, the pressure sensor 40b monitors the pressure of the leukocyte reduction filter 62. When the pressure sensor 40b detects that the pressure of the leukocyte reduction filter 62 has exceeded a predetermined pressure threshold (which may indicate filter clogging), the control unit reconfigures the valve system (from the configuration of FIG. 7 to the configuration of FIG. 8) so that the mixture bypasses the leukocyte reduction filter 62. Thereafter, the system warns the operator that the RBC product was not leukocyte reduced.

[0072] Regardless of whether the collected red blood cells are leukocyte reduced (or partially leukocyte reduced), the collection stage continues until a target volume of whole blood is drawn from the blood source into the fluid flow circuit 12. When the whole blood container 44 is used as the blood source (as in the illustrated embodiment), the collection stage ends when the whole blood container 44 (which may be filled with the target volume of whole blood) is empty, and various approaches may be employed to determine that the whole blood container 44 is empty. For example, in one embodiment, the pressure sensor 40c monitors the hydrostatic pressure of the whole blood container 44. When the hydrostatic pressure measured by the pressure sensor 40c falls below a threshold value, it may be detected that the whole blood container 44 is empty. Alternatively (or additionally), the weight of the whole blood container 44 may be monitored with a weighing scale, and it may be detected that the whole blood container 44 is empty when the weight falls below a threshold value. In the case of a living donor (or when the whole blood container 44 contains more than the target volume of blood), the volumetric flow rate of the whole blood pump 16 may be used to determine whether the target volume of whole blood has been drawn into the fluid flow circuit 12.

[0073] When the target volume of whole blood is drawn into the fluid flow circuit 12, the control unit transitions the procedure to the "red blood cell collection" stage shown in FIG. 9. In the red blood cell collection stage, air from the plasma collection container 48 (which was carried there during the blood priming stage) is used to collect the contents of the processing chamber 52 (which may mainly be red blood cells), reducing product loss.

[0074] In the illustrated embodiment, the whole blood pump 16 is stopped and the plasma pump 18 is operated in the reverse direction (relative to the direction of operation up to this stage of the procedure). As a result, air is drawn into line L7 from the plasma collection container 48. Valve 38a is closed, clamp 24c is opened, and the air passes through line L7, enters line L3, and enters the processing chamber 52 via the plasma outlet port. Due to the air flowing through the plasma outlet port, the air enters the processing chamber 52 from the low-g side. When more air is introduced into the processing chamber 52, the air moves from the low-g wall towards the high-g wall, and the liquid contents move through the high-g side red blood cell outlet port into line L4. At this stage, the centrifuge 22 may operate at a lower speed (for example, in the range of about 1,000 to 2,000 rpm) to reduce the risk of air blockage (similar to the case during the blood priming stage).

[0075] Additive pump 20 continues to operate, draws the additive solution from additive solution container 42 through line L10, and mixes it with the contents of 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 pass through line L5. If the valve system was arranged in the configuration of FIG. 7 at the end of the collection stage (to allow it to flow through leukocyte reduction filter 62), valves 38a, 38b, and 38c remain closed, valve 38d is open, and the mixture can be sent to line L11 for leukocyte reduction (see FIG. 9). On the other hand, if the valve system was arranged in the configuration of FIG. 8 at the end of the collection stage (to bypass leukocyte reduction filter 62), valves 38a, 38c, and 38d remain closed, valve 38b is open, and the mixture can be sent to lines L8 and L13 to bypass leukocyte reduction filter 62 (see FIG. 10). As described above regarding the collection stage, the control unit can change the configuration of the valve system from the configuration shown in FIG. 9 to the configuration of FIG. 10 and stop leukocyte reduction of the mixture during the erythrocyte collection stage (for example, when the pressure of leukocyte reduction filter 62 is too high).

[0076] Regardless of whether the mixture is filtered, the mixture flows into line L12 and through open clamp 24b into erythrocyte collection container 46. The erythrocyte collection stage continues until all air is removed from plasma collection container 48. In one embodiment, the weight of plasma collection container 48 is monitored by a weighing scale, and when the weight falls below a threshold, an empty plasma collection container 48 is detected. Other approaches can also be used, such as using optical sensor 34 to detect plasma flowing through line L3, to determine the timing to end the erythrocyte collection stage.

[0077] When the red blood cell collection stage is completed, the procedure proceeds to the "additive solution flush" stage. In the additive solution flush stage, the additive solution from the additive solution container 42 is conveyed into the red blood cell collection container 46 until the target amount of additive solution has entered the red blood cell collection container 46. The only change in transitioning from the red blood cell collection stage to the additive solution flush stage is to deactivate the plasma pump (and close the clamp 24c) to prevent the removal of plasma from the plasma collection container 48 (it is also possible for the additive pump 20 to operate at a different speed). Thus, if the valve system is arranged to direct the flow through the leukocyte reduction filter 62 at the end of the red blood cell collection stage (as in FIG. 9), the additive solution flush stage proceeds as shown in FIG. 11. On the other hand, if the valve system is arranged to bypass the leukocyte reduction filter 62 at the end of the red blood cell collection stage (as in FIG. 10), the additive solution flush stage proceeds as shown in FIG. 12. When the additive solution is pumped through the leukocyte reduction filter 62 during the additive solution flush stage (as in FIG. 11), 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 the appropriate volume of additive solution for the red blood cell product).

[0078] The flush stage of the additive solution continues until the target amount of additive solution has been added to the red blood cell collection container 46. As an example, the weight of the additive solution container 42 is monitored by a weighing scale, and a specific weight change corresponds to the target amount of additive solution conveyed to the red blood cell collection container 46. Alternatively (or additionally), the weight of the red blood cell collection container 46 is monitored by a weighing scale, and a specific weight change corresponds to the target amount of additive solution conveyed to the red blood cell collection container 46.

[0079] When the flash stage of the additive solution is complete, the system proceeds in one of two ways. If the RBCs remain in the RBC collection container 46 (which does not contain DEHP), the system moves to the "air expulsion" stage, causing the RBC collection container 46 to "burp" to remove any residual air for storage (in the same manner as air was removed from the plasma collection container 48 during the RBC collection stage). This is done by reversing the direction of operation of the additive pump 20, closing the valve 38d (if it is not already closed at the end of the additive solution flash stage), and opening the valve 38b (if it is not already open at the end of the additive solution flash stage). The additive pump 20 sucks air from the RBC collection container 46, passes it through line L12 and the open clamp 24b, sends the air to line L13, and passes it through the open valve 38b. The air passes through lines L8, L5, L10, and ultimately reaches the additive solution container 42. Alternatively, instead of expelling air from the RBC collection container 46 to the additive solution container 42, it is also within the scope of the present disclosure to direct all or part of the air to another location in the fluid flow circuit 12 (e.g., the processing chamber 52 and / or the whole blood container 44 if provided).

[0080] The air expulsion stage continues until all air is removed from the RBC collection container 46, which can be determined (e.g., using a weighing scale) by detecting a change in the weight of the RBC collection container 46 (for example).

[0081] On the other hand, it is also within the scope of the present invention to store the RBCs in a container other than the RBC collection container 46 at the end of the treatment. In this case, instead of performing the air expulsion stage, the control unit of the treatment device 10 can perform an "RBC transfer" stage as shown in FIG. 13. In the illustrated RBC transfer stage, the RBCs in the RBC collection container 46 are conveyed to the (non-DEHP) whole blood container 44 for collection and storage. This stage can be performed regardless of whether the RBC collection container 46 is formed of a DEHP-free material or a DEHP-containing material, but it is particularly advantageous when the RBC collection container 46 is formed of a DEHP-containing material.

[0082] As described above, containers containing additives are not compatible with radiation sterilization. Since the whole blood container 44 contains an anticoagulant solution, it cannot be radiation sterilized. Therefore, the whole blood container is prepared separately from the rest of the associated fluid flow circuit (which is radiation sterilized) and needs to be sterilized separately (for example, using steam). When the whole blood container 44 is sterilized, it is aseptically connected to one of the conduits of the fluid flow circuit immediately before use of the fluid flow circuit.

[0083] As also described above, containers formed of DEHP-free materials (for example, citrate plasticized materials) are also not compatible with radiation sterilization, so an aseptic connection to the associated fluid circuit after sterilization is also required. Therefore, when the fluid flow circuit is provided with a non-DEHP red blood cell collection container and a whole blood container containing an anticoagulant solution, it is necessary to aseptically connect the two containers to the rest of the fluid flow circuit, increasing the time and cost of the blood separation procedure. On the other hand, if the procedure ends with the RBC product in the non-DEHP whole blood container 44, only one (aseptic) connection (of the non-DEHP whole blood container 44) is required because the red blood cell collection container 46 (which may be formed of a material containing DEHP) can be pre-attached to the fluid flow circuit 12 and radiation sterilized. As is clear, this reduces the time and cost involved in performing the blood separation procedure.

[0084] During the red blood cell transfer phase, the operation of the additive pump 20 is stopped, and the whole blood pump 16 operates in the reverse direction (compared to the operation direction in the previous phase). At this time, the clamp 24a and the valve 38f are also opened. The valve 38d is closed (if it has not been closed at the end of the additive solution flush phase), and the valve 38b is opened (if it has not been opened at the end of the additive solution flush phase). The whole blood pump 16 draws the RBC product from the red blood cell collection container 46 through the line L12 and the open clamp 24b into the line L13, and draws the RBC product through the open valve 38b. Since the valves 38a and 38c remain closed, the RBC product continues to pass through the line L8 and the line L5. Since the additive pump 20 is not operating and the valve 38e remains closed, the RBC product flows from the line L5 to the line L14, passes through the open valve 38f, and finally reaches the whole blood container 44 through the line L1 (and the open clamp 24a).

[0085] The red blood cell transfer phase continues until all (or at least the target amount) of the RBC product is removed from the red blood cell collection container 46, which can be determined (for example) by detecting a change in the weight of the red blood cell collection container 46 (using, for example, a weighing scale). In one embodiment, the system state shown in FIG. 13 continues even after the RBC product has emptied from the red blood cell collection container 46, and an amount of air is withdrawn from the red blood cell collection container 46. This is not for improving the preservation of the RBC product in the red blood cell collection container 46 (like the air discharge phase described above), but rather is considered an alternative "air discharge" phase because air is removed from the red blood cell collection container 46 to enable more complete transfer of the RBC product to the whole blood container 44. More specifically, during this alternative air discharge phase, the 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 remaining RBC product in the path into the whole blood container 44 and ensuring that the RBC product is more completely collected.

[0086] When the air exhaust phase or the red blood cell transfer phase or the alternative air exhaust phase is completed, any of several post-treatment phases may be performed. For example, FIG. 14 shows a "sealing" phase in which all clamps and valves are closed and all pumps are stopped. In the illustrated embodiment (where the red blood cell 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 cut as needed for storage of the red blood cell product and the plasma product. Alternatively, if the red blood cell product is stored in the red blood cell collection container 46, the line L12 (not the line L1 connected to the whole blood container 44) connected to the red blood cell collection container 46 may be sealed and cut as needed for storage of the red blood cell product.

[0087] For the cut lines, the associated containers can be stored and the rest of the fluid flow circuit 12 can be disposed of. The lines can be sealed (and optionally cut) according to any suitable method, such as being incorporated into a suitable clamp or sealed by an associated RF sealer. In another embodiment, the fluid flow circuit 12 can be removed from the processing device 10 and suitable lines can be sealed (and optionally cut) using a dedicated sealing device.

[0088] Aspect Aspect 1: A blood treatment system comprising a reusable treatment device and a disposable fluid flow circuit. The reusable treatment device includes a pump system, a blood separation assembly, and a control unit configured to execute a blood treatment procedure. The disposable fluid flow circuit includes a treatment chamber received by the blood separation assembly, a red blood cell collection container containing an additive solution, an additive solution container, and a plurality of conduits fluidly connecting the components of the fluid flow circuit. The control unit is configured to operate the pump system to convey the additive solution from the red blood cell collection container to the additive solution container, operate the pump system to convey blood from a blood source to the treatment chamber, operate the blood separation assembly to separate red blood cells from the blood in the treatment chamber, operate the pump system to convey at least a portion of the separated red blood cells from the treatment chamber to the red blood cell collection container, and operate the pump system to convey at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

[0089] Aspect 2: The blood treatment system according to Aspect 1, wherein the additive solution container is substantially empty before the control unit operates the pump system to convey the additive solution from the red blood cell collection container to the additive solution container.

[0090] Aspect 3: The blood treatment system according to Aspect 1 or Aspect 2, wherein the red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0091] Aspect 4: The blood treatment system according to any one of Aspects 1 to 3, wherein the additive solution container is formed of a material that contains di-2-ethylhexyl phthalate.

[0092] Aspect 5: The blood treatment system according to any one of Aspects 1 to 4, wherein the red blood cell collection container is formed of a material that contains a citrate plasticizer.

[0093] Aspect 6: The blood treatment system according to any one of Aspects 1 to 5, wherein the red blood cell collection container is provided separately from the fluid flow circuit and is configured to be aseptically connected to one of the conduits of the fluid flow circuit.

[0094] Aspect 7: The addition solution container is pre-attached to one of the conduits of the fluid flow circuit, and the blood treatment system according to any one of Aspects 1 to 6.

[0095] Aspect 8: The control unit is configured to execute the blood treatment procedure so as to hold at least a part of the separated red blood cells and at least a part of the addition solution in the red blood cell collection container at the end of the blood treatment procedure, and the blood treatment system according to any one of Aspects 1 to 7.

[0096] Aspect 9: The control unit is configured to execute the blood treatment procedure so as to hold at least a part of the separated red blood cells and at least a part of the addition solution in a container other than the red blood cell collection container at the end of the blood treatment procedure, and the blood treatment system according to any one of Aspects 1 to 7.

[0097] Aspect 10: The blood source includes a whole blood container, and the control unit is configured to execute the blood treatment procedure so as to hold at least a part of the separated red blood cells and at least a part of the addition solution in the whole blood container at the end of the blood treatment procedure, and the blood treatment system according to Aspect 9.

[0098] Aspect 11: A method for separating red blood cells from whole blood, including transporting an addition solution from an addition solution container to a red blood cell collection container, transporting blood from a blood source to a treatment chamber, separating red blood cells from the blood in the treatment chamber, transporting at least a part of the separated red blood cells from the treatment chamber to the red blood cell collection container, and transporting at least a part of the addition solution from the addition solution container to the red blood cell collection container.

[0099] Aspect 12: The addition solution container is substantially empty before transporting the addition solution from the red blood cell collection container to the addition solution container, and the method according to Aspect 11.

[0100] Aspect 13: The red blood cell collection container is formed of a material that does not contain di-2-ethylhexyl phthalate, and the method according to Aspect 11 or Aspect 12.

[0101] 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.

[0102] 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 containing a citrate plasticizer.

[0103] 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 a treatment chamber.

[0104] 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 a treatment chamber.

[0105] Aspect 18 The method according to any one of Aspects 11 to 17, which ends by holding at least a part of the separated red blood cells and at least a part of the additive solution in the red blood cell collection container.

[0106] Aspect 19 The method according to any one of Aspects 11 to 17, which ends by holding at least a part of the separated red blood cells and at least a part of the additive solution in a container other than the red blood cell collection container.

[0107] Aspect 20 The blood source includes a whole blood container, The method according to Aspect 19, which ends by holding at least a part of the separated red blood cells and at least a part of the additive solution in the whole blood container.

[0108] Aspect 21: A blood treatment system comprising a reusable treatment device and a disposable fluid flow circuit. The reusable treatment device includes a pump system, a blood separation assembly, and a control unit configured to execute a blood treatment procedure. The disposable fluid flow circuit includes a treatment chamber received by the blood separation assembly, a red blood cell collection container, a whole blood container, and a plurality of conduits fluidly connecting the components of the fluid flow circuit. The control unit is configured to operate the pump system to convey blood from the whole blood container to the treatment chamber, operate the blood separation assembly to separate red blood cells from the blood in the treatment chamber, operate the pump system to convey at least a portion of the separated red blood cells from the treatment chamber to the red blood cell collection container, and operate the pump system to convey at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0109] Aspect 22: The blood treatment system according to Aspect 21, wherein the red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate.

[0110] Aspect 23: The blood treatment system according to Aspect 21, wherein the red blood cell collection container is formed of a material not containing di-2-ethylhexyl phthalate.

[0111] Aspect 24: The blood treatment system according to any one of Aspects 21 to 23, wherein the whole blood container is formed of a material not containing di-2-ethylhexyl phthalate.

[0112] Aspect 25: The blood treatment system according to any one of Aspects 21 to 24, wherein the blood separation assembly is configured as a centrifuge.

[0113] Aspect 26: The blood treatment system according to any one of Aspects 21 to 25, wherein the control unit is further configured to operate the pump system to convey a certain amount of air from the red blood cell collection container after conveying at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container.

[0114] Aspect 27: The fluid flow circuit includes an additive solution container, and the control unit is configured to operate the pump system to convey the additive solution from the additive solution container to the red blood cell collection container before operating the pump system to convey at least a part of the separated red blood cells from the red blood cell collection container to the whole blood container. The blood treatment system according to any one of Aspects 21 to 26.

[0115] Aspect 28: The additive solution container is substantially empty before the control unit operates the pump system to convey blood from the whole blood container to the processing chamber. The blood treatment system according to Aspect 27.

[0116] Aspect 29: The red blood cell collection container initially contains an additive solution. The control unit is configured to operate the pump system to convey the additive solution from the red blood cell collection container to the additive solution container before operating the pump system to convey blood from the whole blood container to the processing chamber. The blood treatment system according to Aspect 27 or Aspect 28.

[0117] Aspect 30: The additive solution container is formed of a material containing di-2-ethylhexyl phthalate. The blood treatment system according to any one of Aspects 27 to 29.

[0118] Aspect 31: A method for separating red blood cells from whole blood, comprising: conveying blood from the whole blood container to the processing chamber; separating red blood cells from the blood in the processing chamber; conveying at least a part of the separated red blood cells from the processing chamber into the red blood cell collection container; and conveying at least a part of the separated red blood cells from the red blood cell collection container into the whole blood container.

[0119] Aspect 32: The red blood cell collection container is formed of a material containing di-2-ethylhexyl phthalate. The method according to Aspect 31.

[0120] Aspect 33: The method according to Aspect 31, wherein the erythrocyte collection container is formed of a material that does not contain di-2-ethylhexyl phthalate.

[0121] 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.

[0122] Aspect 35: The method according to any one of Aspects 31 to 34, wherein separating erythrocytes from blood in the processing chamber includes separating erythrocytes from blood via centrifugation.

[0123] Aspect 36: The method according to any one of Aspects 31 to 35, further including conveying a certain amount of air from the erythrocyte collection container after at least a part of the separated erythrocytes is conveyed from the erythrocyte collection container to the whole blood container.

[0124] Aspect 37: The method according to any one of Aspects 31 to 36, further including conveying an additive solution from the additive solution container to the erythrocyte collection container before at least a part of the separated erythrocytes is conveyed from the erythrocyte collection container into the whole blood container.

[0125] Aspect 38: The method according to Aspect 37, wherein the additive solution container is substantially empty before the blood is conveyed from the whole blood container into the processing chamber.

[0126] Aspect 39: The erythrocyte collection container initially contains an additive solution, and the method includes conveying the additive solution from the erythrocyte collection container into the additive solution container before the blood is conveyed from the whole blood container into the processing chamber, according to the method described in Aspect 37 or Aspect 38.

[0127] Aspect 40: The method according to any one of Aspects 37 to 39, wherein the additive solution container is formed of a material that contains di-2-ethylhexyl phthalate.

[0128] It will be understood that the foregoing embodiments and examples show some applications of the principles of the present invention. Those skilled in the art can make numerous modifications 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 the present invention is not limited to the above description, but is as set forth in the following claims, which are to be directed to the features of the present invention, including combinations of features individually disclosed or claimed herein.

Claims

1. A blood processing system, Equipped with a reusable processing unit and a disposable fluid flow circuit, The aforementioned reusable processing device is Pump system and, Blood separation assembly, Includes a control unit configured to perform a blood processing procedure, The aforementioned disposable fluid flow circuit is A processing chamber that receives the blood by the aforementioned blood separation assembly, A red blood cell collection container containing the additive solution, Addition solution container, The fluid flow circuit includes a plurality of conduits that fluidly connect the components of the fluid flow circuit, The control unit, The pump system is activated to transport the additive solution from the red blood cell collection container to the additive solution container. The pump system is activated to transport blood from the blood source to the processing chamber. The blood separation assembly is activated to separate red blood cells from the blood in the processing chamber. The pump system is activated to transport at least a portion of the separated red blood cells from the processing chamber to the red blood cell collection container. A blood processing system configured to operate the pump system to transport 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 control unit operates the pump system to transport the additive solution from the red blood cell collection container to the additive solution container.

3. The blood processing system according to claim 1, wherein the red blood cell collection container is made of a material that does not contain di-2-ethylhexyl phthalate.

4. The blood processing system according to claim 1, wherein the additive solution container is formed of a material containing di-2-ethylhexyl phthalate.

5. The blood processing system according to claim 1, wherein the red blood cell collection container is formed of a material containing a citrate plasticizer.

6. The blood processing system according to claim 1, wherein the red blood cell collection container is provided separately from the fluid flow circuit and is configured to be sterilely connected to one of the conduits of the fluid flow circuit.

7. The blood processing system according to claim 1, wherein the additive solution container is pre-attached to one of the conduits of the fluid flow circuit.

8. The blood processing system according to claim 1, wherein the control unit is configured to perform the blood processing procedure such that, at the end of the blood processing procedure, at least a portion of the separated red blood cells and at least a portion of the added solution are retained in the red blood cell collection container.

9. The blood processing system according to claim 1, wherein the control unit is configured to perform the blood processing procedure such that, at the end of the blood processing procedure, it holds at least a portion of the separated red blood cells and at least a portion of the added solution in a container other than the red blood cell collection container.

10. The aforementioned blood source includes a whole blood container. The blood processing system according to claim 9, wherein the control unit is configured to perform the blood processing procedure such that, at the end of the blood processing procedure, at least a portion of the separated red blood cells and at least a portion of the added solution are retained in the whole blood container.

11. A method for separating red blood cells from whole blood, The process involves transferring the additive solution from the red blood cell collection container to the additive solution container, Transporting blood from the blood source to the processing room, The process involves separating red blood cells from the blood within the aforementioned processing chamber, Transporting at least a portion of the separated red blood cells from the processing chamber to the red blood cell collection container, A method comprising transferring at least a portion of the additive solution from the additive solution container to the red blood cell collection container.

12. The method according to claim 11, wherein the additive solution container is substantially empty before the additive solution is transferred from the red blood cell collection container to the additive solution container.

13. The method according to claim 11, wherein the red blood cell collection container is made of a material that does not contain di-2-ethylhexylphthalate.

14. The method according to claim 11, wherein the additive solution container is formed of a material containing di-2-ethylhexylphthalate.

15. The method according to claim 11, wherein the red blood cell collection container is formed of a material containing a citrate plasticizer.

16. The method according to claim 11, further comprising aseptically connecting the red blood cell collection container to a fluid flow circuit including the processing chamber.

17. The method according to claim 11, wherein the additive solution container is pre-attached to the fluid flow circuit including the processing chamber.

18. The method according to claim 11, wherein the method is completed by retaining at least a portion of the separated red blood cells and at least a portion of the added solution in the red blood cell collection container.

19. The method according to claim 11, wherein the method is completed by retaining at least a portion of the separated red blood cells and at least a portion of the added solution in a container other than the red blood cell collection container.

20. The aforementioned blood source includes a whole blood container. The method according to claim 19, wherein the method is completed by retaining at least a portion of the separated red blood cells and at least a portion of the added solution in the whole blood container.

21. A blood processing system, Equipped with a reusable processing unit and a disposable fluid flow circuit, The aforementioned reusable processing device is Pump system and, Blood separation assembly, Includes a control unit configured to perform a blood processing procedure, The aforementioned disposable fluid flow circuit is A processing chamber that receives the blood by the aforementioned blood separation assembly, Red blood cell collection container, whole blood container, The fluid flow circuit includes a plurality of conduits that fluidly connect the components of the fluid flow circuit, The control unit, The pump system is activated to transport blood from the whole blood container to the processing room. The blood separation assembly is activated to separate red blood cells from the blood in the processing chamber. The pump system is activated to transport at least a portion of the separated red blood cells from the processing chamber to the red blood cell collection container. A blood processing system configured to operate the pump system to transport 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 made of a material that does not contain di-2-ethylhexylphthalate.

24. The blood processing system according to claim 21, wherein the whole blood container is formed of a material that does not contain di-2-ethylhexyl phthalate.

25. The blood processing system according to claim 21, wherein the blood separation assembly is configured as a centrifuge.

26. The blood processing system according to claim 21, wherein the control unit is further configured to transport at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container, and then to operate the pump system to transport a certain amount of air from the red blood cell collection container.

27. The fluid flow circuit includes an additive solution container. The blood processing system according to claim 21, wherein the control unit is configured to operate the pump system to transport the additive solution from the additive solution container to the red blood cell collection container before operating the pump system to transport 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 control unit operates the pump system to transport blood from the whole blood container to the processing chamber.

29. The red blood cell collection container initially contained the additive solution, The blood processing system according to claim 27, wherein the control unit is configured to operate the pump system to transport the additive solution from the red blood cell collection container to the additive solution container before operating the pump system to transport the blood from the whole blood container to the processing chamber.

30. The blood processing system according to claim 27, wherein the additive solution container is formed of a material containing di-2-ethylhexyl phthalate.

31. A method for separating red blood cells from whole blood, Transporting blood from whole blood containers to the processing room. The process involves separating red blood cells from the blood within the aforementioned processing chamber, Transporting at least a portion of the separated red blood cells from the processing chamber into a red blood cell collection container, A method comprising transporting at least a portion of the separated red blood cells from the red blood cell collection container 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 made of a material that does not contain di-2-ethylhexylphthalate.

34. The method according to claim 31, wherein the whole blood container is formed of a material that does not contain di-2-ethylhexylphthalate.

35. The method according to claim 31, wherein separating red blood cells from the blood in the processing chamber includes separating red blood cells from the blood by centrifugation.

36. The method according to claim 31, further comprising transporting at least a portion of the separated red blood cells from the red blood cell collection container to the whole blood container, and then transporting a certain amount of air from the red blood cell collection container.

37. The method according to claim 31, further comprising transporting the additive solution from the additive solution container to the red blood cell collection container before transporting 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 according to claim 37, wherein the additive solution container is substantially empty before the blood is transported from the whole blood container into the processing chamber.

39. The red blood cell collection container initially contains the additive solution, The method according to claim 37, wherein the method comprises transporting the additive solution from the red blood cell collection container into the additive solution container before transporting the blood from the whole blood container into the processing chamber.

40. The method according to claim 37, wherein the additive solution container is formed of a material containing di-2-ethylhexylphthalate.

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