Method for predicting whole blood platelet count

Abstract

To provide systems, devices and methods for estimating the concentration of platelets in a donor's circulating blood during a blood processing procedure.SOLUTION: Blood processing systems, devices and methods include a durable hardware component 10, a single-use fluid flow circuit, and a controller 18 configured to estimate the concentration of platelets in a donor's circulating blood.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure generally relates to systems, devices, and methods for processing blood. More specifically, the present disclosure generally relates to systems, devices, and methods for separating platelets from whole blood. Further, the present disclosure relates to systems, devices, and methods for estimating the platelet concentration in a donor's circulating blood during a blood processing procedure.

Background Art

[0002] Currently, various blood processing systems enable the collection of specific blood components rather than whole blood from a blood source. Typically, in such systems, whole blood is collected from a blood source, specific blood components or constituents are separated, removed, and collected, and the remaining blood components are returned to the blood source. Removing only specific components is advantageous when the blood source is a human donor. This is because the time required for the donor's body to return to pre-donation levels may be shortened, and donations can be made more frequently than when collecting whole blood. This increases the overall supply of blood components such as plasma and platelets available for transplantation and / or therapeutic procedures.

[0003] Estimating the donor's circulating platelet concentration is an important part of any platelet collection procedure. The donor's platelet concentration is necessary for the system to calculate the number of platelets collected (yield), and is also necessary for system safety measures to ensure that the donor's platelet count does not fall below an acceptable limit such as 100e3 platelets / μL. Currently, blood processing systems apply complex mathematical algorithms to estimate the yield and donor concentration based on the donor platelet pre-count entered into the system before the start of collection. Although effective, there are some errors and a major limitation in that a donor pre-count is required. Therefore, it is desirable to perform safe platelet collection without the need for donor platelet pre-count measurement.

[0004] Accordingly, there is a need for an apparatus, system, and method for estimating the platelet concentration in a donor during a blood processing procedure. SUMMARY OF THE INVENTION

[0005] The subject matter of the present invention has several aspects that can be implemented individually or together in the apparatus, system, and method described and / or 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 or later amended. For the purposes of this description and the claims, unless otherwise specified, "blood" shall be taken to include whole blood and blood components such as concentrated red blood cells, plasma, platelets, white blood cells, etc., whether or not an anticoagulant or additive is present.

[0006] In one aspect, a system for collecting platelets is provided. The system includes a reusable hardware unit that includes a separator, a disposable fluid circuit configured to be associated with the reusable hardware unit, and a control unit configured to estimate the platelet concentration of the donor's circulating blood.

[0007] In another aspect, a method for processing whole blood from a donor is provided. The method includes collecting whole blood from the donor, separating the collected whole blood into blood components including separated platelets, collecting the separated platelets, and estimating the platelet concentration of the donor's blood during the processing.

[0008] These and other aspects of the present invention are described in the following detailed description of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a perspective view of an example of a reusable blood separation device.

[0010] Figure 2 is a schematic diagram of a disposable fluid circuit associated with a blood separation device.

[0011] Figure 3 is a plan view of an exemplary cassette of a fluid flow circuit associated with the blood separation device shown in Figure 1.

[0012] Figure 4 is a flowchart showing a method for determining the platelet concentration in a donor's circulating blood.

DETAILED DESCRIPTION OF THE INVENTION

[0013] The embodiments disclosed herein are intended to provide an exemplary description of the subject matter. However, these are merely examples and not exclusive, and the subject matter of the present invention may be embodied in various forms. Therefore, the specific details disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0014] Figures 1 - 3 show the components of a blood or fluid separation system embodying various aspects of the subject matter of the present invention. In this specification, this system may be referred to as a "blood processing system" or a "blood separation system", but it should be understood that the system according to the present disclosure can be used to process various fluids including body fluids and non - body fluids. In particular, a blood processing system can be configured to separate whole blood into its components including a concentrated platelet product. In one embodiment, the blood processing system is a system configured to separate and collect platelet products from whole blood.

[0015] Generally, this system can include two main components: a durable and reusable hardware unit (i.e., a blood separation device) 10 (FIG. 1) and a disposable fluid flow circuit 12 (FIG. 2). The blood separation device 10 can include a rotary membrane separator drive unit 14, a centrifuge or centrifugal separator 16, additional components for controlling the flow of fluid through the disposable fluid flow circuit 12, and a control unit 18 for controlling the operation of the other components of the blood separation device 10 to perform the blood processing and collection procedures selected by the operator. This will be described in more detail later.

[0016] Referring to FIG. 1, this figure shows an example of a reusable blood separation device 10. The blood separation device 10 is configured as a durable item for long-term use. It should be understood that the blood separation device 10 is merely an example of one possible configuration, and blood separation devices according to the present disclosure may have different configurations. The blood separation device 10 is the blood separation device disclosed in U.S. Patent No. 11,465,160, filed on February 22, 2019, which is incorporated herein by reference in its entirety, but other blood separation devices configured to collect platelet products known in the art may also be used.

[0017] In one embodiment, the blood separation device 10 may be a portable device configured to be placed on a generally horizontal support surface (e.g., a countertop or tabletop) installed at a high location. However, it is also within the scope of the present disclosure to include a support base that allows the device 10 to be placed in an appropriate position and orientation when placed on the floor or ground. Although it is advantageous for the blood separation device 10 to be portable, it is also within the scope of the present disclosure to install the blood separation device 10 in a single location and keep it there for a long time. When the blood separation device is provided as a fixture, it may have more components and functions than when it is more portable.

[0018] As shown, the blood separation device 10 includes a rotor support or a rotating membrane separator drive unit 14 for accommodating a generally cylindrical rotating membrane separator 26 (FIG. 2) of the fluid flow circuit 12. U.S. Patent No. 5,194,145, which is incorporated herein by reference in its entirety, describes an exemplary rotating membrane separator drive unit suitable for incorporation into the blood separation device 10. However, it should be understood that the rotating membrane separator drive unit 14 can be configured differently without departing from the scope of the present disclosure.

[0019] The illustrated rotating membrane separator drive unit 14 has a base 28 configured to accommodate the lower portion of the rotating membrane separator 26 and an upper end cap 30 configured to accommodate the upper portion of the rotating membrane separator 26. Preferably, the upper end cap 30 is located directly above the base 28, vertically orienting the rotating membrane separator 26 accommodated by the rotating membrane separator drive unit 14 and defining a vertical axis about which the rotating membrane separator 26 rotates. Although it is advantageous for the rotating membrane separator drive unit 14 to vertically orient the rotating membrane separator 26, it is also within the scope of the present disclosure for the rotating membrane separator 26 to be oriented differently when attached to the blood separation device 10.

[0020] At least one of the base 28 and the upper end cap 30 is configured to rotate one or more components of the rotating membrane separator 26 about an axis defined by the rotating membrane separator drive unit 14. The mechanism by which the rotating membrane separator drive unit 14 rotates one or more components of the rotating membrane separator 26 is similar to that described in the previously incorporated U.S. Patent No. 11,465,160 and can be modified without departing from the scope of the present disclosure.

[0021] Regardless of the mechanism by which the rotating membrane separator drive unit 14 rotates the components of the rotating membrane separator 26, the components of the rotating membrane separator 26 preferably rotate at a speed sufficient to generate Taylor vortices in the gap between the rotating and stationary (or differently rotating) components of the rotating membrane separator 26. The fluid separated within the rotating membrane separator 26 flows through this gap, and the generation of Taylor vortices can dramatically improve filtration.

[0022] The separation device 10 may also include a centrifuge 16. In one embodiment, the separation device 10 may include a centrifuge 16 and / or a centrifuge chamber 32 that can accommodate other components of the centrifuge 16. The centrifuge chamber 32 may include a lid (not shown) that is opened to insert and remove the centrifuge chamber 36 of the fluid flow circuit 12. During the separation procedure, when the centrifuge chamber 36 is placed within the centrifuge chamber 32 and the centrifuge chamber 36 is rotated or pivoted about an axis under the power of an electric drive motor or rotor of the centrifuge 16, the lid can be closed.

[0023] To monitor the separation of blood within the centrifuge chamber 36, components of an interface monitoring system can be placed within the centrifuge chamber 32. The interface monitoring system includes a light source 50 and a photodetector 52 that is arranged and oriented to receive at least a portion of the light emitted by the light source 50. Preferably, the light source 50 and the photodetector 52 are arranged on a fixed surface of the centrifuge chamber 32, but it is also within the scope of the present disclosure to attach one or both to a movable component of the centrifuge 16 (e.g., a yoke member that rotates at 1 omega speed). A more detailed description of an example of the interface monitoring system is disclosed in previously incorporated U.S. Patent No. 11,465,160.

[0024] In addition to the rotary membrane separator drive unit 14 and the centrifuge 16, the blood separation device 10 may include other components that are compactly arranged to assist in blood processing.

[0025] For example, the blood separation device 10 includes a cassette station 54 that houses a cassette 48 of the fluid flow circuit 12 (FIG. 3). In one embodiment, the cassette station 54 is configured similarly to the cassette station of U.S. Patent No. 5,868,696, which is incorporated herein by reference, but is adapted to include additional components and functions. The illustrated cassette station 54 includes a plurality of clamps or valves V1-V9 (FIG. 1), which move between a plurality of positions (e.g., a retracted or lowered position and an actuated or raised position) to selectively contact or interact with corresponding valve stations C1-C9 of the cassette 48 of the fluid flow circuit 12. Depending on the configuration of the fluid flow circuit 12, the cassette 48 thereof may not include valve stations C1-C9 for each of the valves V1-V9 of the cassette station 54. In that case, fewer valves than all of the valves V1-V9 are used in the separation procedure.

[0026] In the actuated position, the valves V1-V9 engage the associated valve stations C1-C9 to prevent fluid flow through the valve stations C1-C9 (e.g., by closing one or more ports associated with the valve stations C1-C9 to prevent fluid flow through that port). In the retracted position, the valves V1-V9 are released from the associated valve stations C1-C9 (or the force of contact with the associated valve stations C1-C9 is reduced compared to when in the actuated position), allowing fluid flow through the valve stations C1-C9 (e.g., by opening one or more ports associated with the valve stations C1-C9 to allow fluid flow through that port). Additional clamps or valves V10 and V11 are disposed outside the cassette station 54 to interact with a part of the fluid flow circuit 12 or valve stations C10 and C11 (which may be the length of a tube) and selectively permit or block fluid flow therethrough. The valves V1-V9 of the cassette station 54 and the corresponding valve stations C1-C9 of the cassette 48 are differently configured and operate differently from the valves V10 and V11 and valve stations C10 and C11 located at positions remote from the cassette station 54.

[0027] The cassette station 54 is provided with additional components such as pressure sensors A1 - A4, which interact with the sensor stations S1 - S4 of the cassette 48 to monitor the pressures at various locations in the fluid flow circuit 12. For example, if the blood source is a human donor, one or more of the pressure sensors A1 - A4 may be configured to monitor the pressure in the donor's vein during blood collection and reinfusion. Other pressure sensors A1 - A4 may monitor the pressures in the rotary membrane separator 26 and the centrifugation chamber 36. The control unit 18 receives signals from the pressure sensors A1 - A4 indicating the pressure within the fluid flow circuit 12, and if the signals indicate a low - pressure or high - pressure state, the control unit 18 may initiate an alarm or error state to warn the operator of that state and / or attempt to bring the pressure to an acceptable level without operator intervention.

[0028] The blood separation device 10 may also include a plurality of pumps P1 - P6 for flowing fluid into the fluid flow circuit 12. The pumps P1 - P6 may have different or similar configurations and / or functions that are similar or different from each other. In the illustrated embodiment, the pumps P1 - P6 are configured as peristaltic pumps, which may be generally configured as described in U.S. Patent No. 5,868,696, which is hereby incorporated by reference in its entirety. Each pump P1 - P6 engages with different tube loops T1 - T6 extending from the side of the cassette 48 (Figure 3) and can be selectively operated under the command of the control unit 18 to flow fluid into a part of the fluid flow circuit 12. This will be described in more detail later. In one embodiment, all or part of the cassette station 54 is movable in translation in and out of the separation device 10, thereby enabling the tube loops T1 - T6 to be automatically loaded onto the associated pumps P1 - P6.

[0029] The illustrated blood separation device 10 also includes a centrifugal fluid sensor M1 for determining one or more characteristics of a fluid flowing into or out of a centrifugal separation chamber 36 mounted within a centrifuge 16. If the fluid flowing into the centrifugal separation chamber 36 is whole blood (which may include anticoagulated whole blood), the sensor M1 may be configured to determine the hematocrit of the blood flowing into the centrifugal separation chamber 36. If the fluid flowing out of the centrifugal separation chamber 36 is platelet-rich plasma, the sensor M1 may be configured to determine the platelet concentration of the platelet-rich plasma flowing into the rotary membrane separator 26. The sensor M1 may detect one or more characteristics of the fluid by optically monitoring the fluid flowing through a tube of the fluid flow circuit 12 or by other suitable methods. The control unit 18 receives a signal from the sensor M1 indicating one or more characteristics of the fluid flowing through the fluid flow circuit 12 and uses that signal to optimize the separation procedure based on that characteristic. If the characteristic is outside an acceptable range, the control unit 18 initiates an alarm or error condition to alert the operator of that condition. Suitable devices and methods for monitoring hematocrit and / or platelet concentration are described in U.S. Patent No. 6,419,822, which is incorporated herein by reference, but it should be understood that other approaches may also be used to monitor the hematocrit and / or platelet concentration of the fluid flowing into the rotary membrane separator 26.

[0030] The illustrated blood separation device 10 further includes a rotor outlet sensor M2 that houses a tube of the fluid flow circuit 12 for discharging a blood component separated from the rotary membrane separator 26. The rotor outlet sensor M2 monitors the fluid to determine one or more characteristics of the fluid. This can be done by optically monitoring the fluid as it flows through the tube or by other suitable methods. In one embodiment, the separated plasma flows through the tube, in which case the rotor outlet sensor M2 can be configured to determine the amount of cellular blood components in the plasma and / or whether the plasma is hemolytic and / or lipemic. This can be done using an optical monitor of the type described in U.S. Patent No. 8,556,793, which is incorporated herein by reference, or by other suitable devices and / or methods.

[0031] The illustrated blood separation device 10 also includes an air detector M3 (e.g., an ultrasonic bubble detector) that houses the tube of the fluid flow circuit 12 that flows fluid to a recipient. Since it may be advantageous to prevent air from reaching the recipient whether the recipient is a human recipient (e.g., the same human who is the blood source) or a non-human recipient (e.g., a storage bag or container), the air detector M3 can send a signal indicating the presence or absence of air in the tube to the control unit 18. If the signal indicates that air is present in the tube, the control unit 18 can initiate an alarm or error state to warn the operator of that state and / or take corrective measures to prevent air from reaching the recipient (e.g., reverse the flow of fluid through the tube or divert the flow to a vent location).

[0032] In one embodiment, the separation device 10 can optionally include a platelet concentrate sensor M4. The sensor M4 may be incorporated into the separation device 10 or may be a stand-alone sensor. The platelet concentrate sensor M4 may be configured to determine the concentration of the concentrated platelet product discharged from the rotating membrane 26. The sensor M4 can detect the concentration of the concentrated platelet product by optically monitoring the fluid flowing through the tube of the fluid flow circuit 12 or by other suitable methods.

[0033] The separation device 10 also includes a plurality of weighing scales W1 to W6 (six are shown, but there may be more or fewer), and each weighing scale can support one or more fluid containers of the fluid flow circuit 12. The fluid containers receive blood components separated during processing, or intravenous fluid or additive fluid. Each of the weighing scales W1 to W6 transmits a signal indicating the weight of the fluid in the associated fluid container to the control unit 18 and tracks changes in weight during the procedure. Thereby, the control unit 18 can process the incremental weight change to derive the fluid treatment volume and flow rate, and then generate a signal for controlling the treatment event based at least in part on the derived treatment volume. For example, the control unit 18 can diagnose leaks or malfunctions in the fluid flow circuit 12 and alert the operator.

[0034] The illustrated separation device 10 is also provided with a plurality of hooks or supports H1 and H2 that can support various components of the fluid flow circuit 12 or other suitable sized and configured objects.

[0035] The blood separation device 10 includes a control unit 18 that is suitably configured and / or programmed to control the operation of the blood separation device 10. In one embodiment, the control unit 18 may be the control unit disclosed in the previously incorporated U.S. Patent No. 11,465,160. In one embodiment, the control unit 18 may be mounted within the separation device 10. Further, the control unit 18 may be adjacent to or incorporated into an operator interface station (e.g., a touch screen) (not shown) and mounted within the separation device 10. In other embodiments, the control unit 18 and the operator interface station may be associated with or incorporated into another device connected (physically, by cable, etc., or wirelessly) to the blood separation device 10.

[0036] When an operator interface station associated with the control unit 18 is provided, the operator can view information regarding the operation of the system on a screen or display (in alphanumeric form and / or as a graphic image). At the operator interface station, the operator can also select the applications executed by the control unit 18 or change specific functions and performance criteria of the system. When configured as a touch screen, the screen of the operator interface station can receive input from the operator by touch operation. When the screen is not a touch screen, the operator interface station can receive input from the operator via another input device such as a computer mouse or keyboard. It is also within the scope of the present disclosure for the operator interface station to receive input from both a touch screen and another input device such as a keypad.

[0037] The control unit 18 is configured and / or programmed to execute at least one blood treatment application. In particular, the control unit 18 is configured and / or programmed to execute a platelet collection procedure. Without departing from the scope of the present disclosure, the control unit 18 can also be configured and / or programmed to execute additional or alternative blood treatment procedures, such as a two-unit red blood cell collection procedure, a plasma collection procedure, a plasma / red blood cell collection procedure, a red blood cell / platelet / plasma collection procedure, a platelet collection procedure, and a platelet / plasma collection procedure.

[0038] More specifically, when executing any of these blood processing applications, the control unit 18 is configured and / or programmed to control one or more of the following tasks. Drawing blood into the fluid flow circuit 12 attached to the blood separation device 10, transporting the blood through the fluid flow circuit 12 to a separation location (i.e., the rotary membrane separator 26 or the centrifugal chamber 36 of the fluid flow circuit 12), separating the blood into two or more components as needed, transporting the separated components to a storage container, a second location for further separation (e.g., the one not used in the first separation stage of the rotary membrane separator 26 or the centrifugal chamber 36), or a recipient (which may be the donor from whom the blood was initially collected).

[0039] This includes instructing the rotary membrane separator drive unit 14 and / or the centrifuge 16 to operate at a specific rotational speed, and instructing pumps P1 to P6 to transport fluid at a specific flow rate to a part of the fluid flow circuit 12. Thus, although a specific component of the blood separation device 10 (e.g., the rotary membrane separator drive unit 14 or the centrifuge 16) is described herein as performing a specific function, it should be understood that the component is controlled by the control unit 18 to perform that function.

[0040] Before, during, and after the procedure, the control unit 18 receives signals from various components of the blood separation device 10 (e.g., pressure sensors A1 to A4 and sensors M1 to M4) and can monitor various aspects of the operation of the blood separation device 10 and the characteristics of the blood and separated blood components flowing through the fluid flow circuit 12. For example, the control unit 18 can monitor the separation interface using an interface control module as described in the previously incorporated U.S. Patent No. 11,465,160. If the operation of any component and / or one or more characteristics of the blood or separated blood components are outside the acceptable range, the control unit 18 can initiate an alarm or error state to warn the operator and / or perform actions to correct the state. Appropriate corrective actions vary depending on the specific error state and may include actions that are performed with or without operator involvement.

[0041] According to the present disclosure, the control unit 18 is configured to monitor and estimate the platelet concentration of the donor's circulating blood (C donor ) throughout a blood treatment procedure such as a platelet separation and collection procedure. The platelet concentration of the donor is necessary for the system to calculate the number of platelets collected (platelet yield) and for system protection to ensure that the donor's platelet count does not fall below an acceptable limit (e.g., 100e3 platelets / μL). By estimating the platelet concentration of the donor's circulating blood during the blood treatment procedure, pre-procedure platelet counting measurements are unnecessary.

[0042] The control unit 18 can determine C donor based on the values obtained by the control unit 18 from various sensors and scales connected to the control unit, and other inputs related to the system, according to the following equations. C WBcent = C PRP × (1 - H Wbcent ) [Equation 1] H Wbcent = (H RBC × Q RBC ) / Q Wbcent [Equation 2] WB% = WB ratio / (WB ratio + AC ratio) [Equation 3] C donor =C Wbcent ×WB% [Equation 4]

[0043] As shown in Equation 4 above, C donor is determined based on the platelet concentration (C Wbcent ) in the collected whole blood entering the centrifuge 16 and the proportion (WB%) of the whole blood in the centrifuge inlet line L149 (shown in Figure 2). In particular, C donor is determined by determining the product of C Wbcent and WB%.

[0044] C Wbcent is calculated based on the platelet concentration of the separated platelet-rich plasma (C PRP ) discharged from the centrifuge chamber 36 and the hematocrit (H Wbcent ) of the collected whole blood entering the centrifuge chamber 36. In particular, C Wbcent is determined by Equation 1, and the difference between 1 and H PRP is multiplied by C Wbcent . In one embodiment, C PRP can be determined using an optical measurement of the platelet-rich plasma discharged from the centrifuge chamber 36. For example, C PRP can be determined by the sensor M1 of the separation device 10. In one embodiment, C PRP can be determined by the optical measurement recorded by the sensor M1 and the platelet concentration estimation method as described in U.S. Patent Application No. 18 / 101,275 filed on January 25, 2023. The disclosure content of this application is hereby incorporated herein by reference in its entirety.

[0045] H Wbcent is determined using the hematocrit of the red blood cells (H RBC ) exiting the centrifuge chamber 36, the flow rate of the red blood cells (Q RBC ) exiting the centrifuge chamber 36, and the flow rate of the whole blood (Q Wbcent ) entering the centrifuge chamber 36. In particular, H Wbcent is determined using Equation 2, and H Wbcent is the product of H RBC and Q RBC divided by Q WbcentIt becomes the value divided by. In one embodiment, H RBC can be assumed to be a constant value (e.g., 85%) empirically derived for all procedures. Alternatively, H RBC can also be estimated by an optical sensor such as sensor M1, or determined by other appropriate methods such as using the flow rate of the centrifuge or the centrifugal force of centrifugation without departing from the scope of the present disclosure. Q RBC is Q Wbcent and the flow rate of the platelet-rich plasma (Q PRP ) discharged from the centrifuge, and Q RBC is Q Wbcent and Q PRP is the difference between. Q Wbcent and Q PRP may be known speeds determined by the pump speeds of the respective pumps 3, 5, the pump rotation feedback, the change of the weighing scale, or a combination of these flow rate monitoring methods. For example, Q Wbcent and Q PRP may be pre-determined flow rates in some cases, or may be determined by the control unit 18 based on data from the weighing scale and / or the optical system in other cases.

[0046] WB% can be determined by dividing the amount (e.g., volume or flow rate) of whole blood in the inlet line entering the centrifuge by the amount (volume or flow rate) of all fluids in the inlet line entering the centrifuge. The all fluids in the inlet line may include whole blood containing additives such as anticoagulants. In one embodiment, WB% can be determined using Equation 3, dividing the fraction of whole blood by the total fraction of whole blood and the fraction of anticoagulant in the inlet line entering the centrifuge. For example, the inlet line may include an anticoagulant ratio of 10:1 (1 part of anticoagulant to 10 parts of whole blood). Therefore, since the collected whole blood is diluted with the anticoagulant solution, C donor is higher than C Wbcent in the collected whole blood entering the centrifuge.

[0047] C donor To determine, by substituting Equations 1, 2, and 3 into Equation 4, the following Equation 5 can be generated. C donor = C PRP × WB% × (1 - ((H RBC × Q RBC )) / Q Wbcent )) [Equation 5].

[0048] Alternatively, C donor is calculated based on the platelet concentration (C PC ) in the platelet concentrate line L162 (shown in FIG. 2) and is not calculated based on the platelet concentrate concentration (C PRP ). In this case, C PRP is replaced by C PC , the flow rate of the platelet concentrate (Q PC ) discharged from the rotary membrane 26, and the flow rate of the platelet concentrate (Q PRP ) entering the rotary membrane 26. C PRP and C PC , Q PC , and Q PRP are related to the values as shown in the following Equation 6. C PRP = (C PC × Q PC ) / Q PRP [Equation 6] C PC can be obtained by optical measurement using the sensor M4 of the separation device 10 or determined by other appropriate methods. Q PC and Q PRP may be predetermined flow rates or may be determined by the control unit 18 based on data from a weighing scale and / or an optical system.

[0049] Therefore, by substituting Equation 6 into Equation 4, C donor can be determined and is expressed as follows. C donor = WB% × ((C PC × Q PC ) / Q PRP ) × (1 - ((H RBC × Q RBC ) / Q Wbcent )) [Equation 7]

[0050] Using Equation 5 or Equation 7, the control unit 18 can estimate C that circulates in the donor's blood throughout the blood treatment procedure. donor In one embodiment, the control unit can be pre-programmed to determine C using either Equation 5 or Equation 7. Alternatively, the control unit 18 can be programmed to determine C using either Equation 5 or Equation 7, and the user can input how to use it using a control unit interface such as a touch screen or a keyboard. By determining C of the donor's circulating blood throughout the blood treatment procedure, it becomes unnecessary to determine the pre-count of platelets. donor In one embodiment, the control unit can be pre-programmed to determine C using either Equation 5 or Equation 7. Alternatively, the control unit 18 can be programmed to determine C using either Equation 5 or Equation 7, and the user can input how to use it using a control unit interface such as a touch screen or a keyboard. By determining C of the donor's circulating blood throughout the blood treatment procedure, it becomes unnecessary to determine the pre-count of platelets. donor In one embodiment, the control unit can be pre-programmed to determine C using either Equation 5 or Equation 7. Alternatively, the control unit 18 can be programmed to determine C using either Equation 5 or Equation 7, and the user can input how to use it using a control unit interface such as a touch screen or a keyboard. By determining C of the donor's circulating blood throughout the blood treatment procedure, it becomes unnecessary to determine the pre-count of platelets. donor In one embodiment, the control unit can be pre-programmed to determine C using either Equation 5 or Equation 7. Alternatively, the control unit 18 can be programmed to determine C using either Equation 5 or Equation 7, and the user can input how to use it using a control unit interface such as a touch screen or a keyboard. By determining C of the donor's circulating blood throughout the blood treatment procedure, it becomes unnecessary to determine the pre-count of platelets.

[0051] As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. donor As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. PRP As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. PC As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. Wbcent As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. RBC As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. PRP As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. PC As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. RBC As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. donor As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. donor As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70. donor As shown in FIG. 4, the control unit 18 can be configured to continuously monitor C in method 70. For example, this method can include steps 72-78 that include, respectively, measurement of the concentration of platelet-rich plasma or platelet concentrate (C or C, respectively), determination of the flow rates Q, Q, Q, and Q, determination of the hematocrit (H) of the concentrated red blood cells exiting the centrifuge chamber 36, and calculation of C using the equations described herein. In one embodiment, steps 72-78 are executed in order and restarted after step 78 (calculation of C). In another embodiment, steps 72-76 are executed in order, in any order, or simultaneously. After executing steps 72-76, the control unit executes step 78, calculates C, and then can restart method 70.

[0052] Furthermore, by continuously monitoring C, C donor Furthermore, by continuously monitoring C, C donorThe control unit 18 can be programmed to issue an alarm or warn the user when it falls below a pre-determined limit, for example, 100e3 / μL. The pre-determined limit can be pre-programmed into the control unit 18 or the user can enter the limit into the control unit interface (if provided) before starting the procedure. In one embodiment, C donor When it falls below the pre-determined limit, the control unit 18 can warn the user to end the procedure and / or can automatically end the procedure. Further, the control unit can be programmed to warn the user that the pre-determined limit is approaching. For example, if the pre-determined limit is 100e3 / μL, the control unit can be programmed to warn the user when C donor it drops to 120e3 / μL. In this case, the user can adjust the target final platelet yield of the process.

[0053] With respect to the fluid flow circuit 12, it is intended to be a sterilized, single-use, disposable item. Before starting a given blood treatment and collection procedure, the operator loads the various components of the fluid flow circuit 12 into the blood separation device 10. The control unit 18 executes the procedure based on a pre-set protocol while considering other inputs from the operator. When the procedure is complete, the operator removes the fluid flow circuit 12 from the blood separation device 10. The portion of the fluid flow circuit 12 that holds the collected blood components (e.g., collection container or bag) is removed from the separation device 10 and retained for storage, transfusion, or further processing. The remaining portion of the fluid flow circuit 12 can be removed from the separation device 10 and discarded.

[0054] In combination with the blood separation device 10, various disposable fluid flow circuits can be used. Suitable fluid flow circuits vary depending on the separation procedure being performed using the system. Generally, the fluid flow circuit 12 includes a cassette 48 (FIG. 3), and the other components of the fluid flow circuit 12 are connected to the cassette 48 by flexible tubing. Other components include a plurality of fluid containers F1 - F7 (for holding blood, separated blood components, intravenous fluid, or additive solution), one or more blood source access devices (e.g., a bleeding needle or connector for accessing the blood in the fluid container), and a rotary membrane separator 26 and / or a centrifugal separation chamber 36.

[0055] The cassette 48 provides a centralized programmable integrated platform for all the pump functions and many of the valve functions required for a particular blood processing procedure. In one embodiment, the cassette 48 is configured similar to the cassette of U.S. Patent No. 5,868,696, but is adapted to include additional components (e.g., more tubing loops T1 - T6) and functions.

[0056] In use, the cassette 48 is attached to the cassette station 54 of the blood separation device 10, and the flexible diaphragm of the cassette 48 contacts the cassette station 54. The flexible diaphragm covers an array of internal cavities formed by the body of the cassette 48. Different internal cavities define sensor stations S1 - S4, valve stations C1 - C9, and a plurality of flow paths. The side of the cassette 48 opposite the flexible diaphragm is sealed by another flexible diaphragm or a rigid cover, thereby sealing the fluid flow through the cassette 48 from the external environment.

[0057] Each sensor station S1 - S4 is aligned in a row with the associated pressure sensors A1 - A4 of the cassette station 54, and each pressure sensor A1 - A4 can monitor the pressure within the associated sensor stations S1 - S4. Each valve station C1 - C9 is aligned in a row with the associated valves V1 - V9 and can define one or more ports that enable fluid communication between the valve stations C1 - C9 and another internal cavity (e.g., a flow path) of the cassette 48. As described above, each valve V1 - V9 is movable in accordance with commands from the control unit 18, moving between a plurality of positions (e.g., between a retracted or lowered position and an actuated or raised position) to selectively contact the valve stations C1 - C9 of the cassette 48. In the actuated position, the valves V1 - V9 engage with the associated valve stations C1 - C9 to close one or more of their ports and prevent fluid flow therethrough. In the retracted position, the valves V1 - V9 are disengaged from the associated valve stations C1 - C9 (or the force of contact with the associated valve stations C1 - C9 is reduced compared to when in the actuated position), and one or more ports associated with the valve stations C1 - C9 open to allow fluid to flow therethrough.

[0058] As described, a plurality of tube loops T1 - T6 extend from the side of the cassette 48 and interact with pumps P1 - P6 of the blood separation device 10. In the illustrated embodiment, six tube loops T1 - T6 extend from the cassette 48 and are received by different ones of the six pumps P1 - P6, but in other embodiments, not all of the pumps P1 - P6 may be required for the procedure, in which case the cassette 48 may include fewer than six tube loops. The different pumps P1 - P6 interact with the tube loops T1 - T6 of the cassette 48 during the separation procedure to perform different tasks, and in one embodiment, different ones of the pumps P1 - P6 may be configured to function as a source pump, an anticoagulant pump, a rotor pump, a separated component pump, an additive pump, and a replacement fluid pump. As will be described later, in certain procedures, not all of the sensor stations, valve stations, and / or tube loops shown in the exemplary cassette 48 of FIG. 3 are required, so the cassettes of the different fluid flow circuits 12 can be of different configurations (e.g., fewer sensor stations, valve stations, and / or tube loops) without departing from the scope of the present disclosure.

[0059] Additional tubes extend from the side of the cassette 48 and are connected to other components of the fluid flow circuit 12, such as various fluid containers F1 - F7, the rotary membrane separator 26 (if provided), the centrifugal separation chamber 36 (if provided), etc. The number and content of the various fluid containers F1 - F7 vary depending on the procedure in which the fluid flow circuit 12 is used.

[0060] Various additional components can be incorporated into the tube exiting the cassette 48 or one of the cavities of the cassette 48. For example, as shown in FIG. 2, a manual clamp 56 can be associated with one or more lines connecting to a blood source and / or a fluid recipient, a return line filter 58 (e.g., a microaggregate filter) can be associated with the line connecting to the fluid recipient, and / or an air trap 62 can be placed in the line upstream of the centrifugation chamber 36. In one embodiment, based on the configuration of the fluid flow circuit 12 and the cassette 48, a particular valve can be replaced with a clamp or vice versa.

[0061] Exemplary separation procedures The separation device 10 can be associated with various fluid circuits configured for specific blood treatment procedures. Here, exemplary blood separation procedures that can be performed using the systems and techniques according to the present disclosure will be described.

[0062] Depending on the purpose of blood separation, there are appropriate procedures for separating and collecting any combination of red blood cells, platelets, white blood cells, and plasma (substantially cell-free). Thus, prior to processing, the operator can select the desired protocol (e.g., using the operator interface station if provided), thereby notifying the control unit 18 of how to control the other components of the blood separation device 10 during the procedure.

[0063] If the blood source is a donor, the operator can proceed to enter various parameters such as the donor's gender / height / weight. In one embodiment, the operator also enters the target yields of the various blood components (including the input of blood characteristics such as platelet pre-count) or other collection control systems (such as the amount of whole blood to be processed).

[0064] If there are fluid containers (e.g., platelet storage solution containers) that are not integrally formed with the fluid flow circuit 12, connect them to the fluid flow circuit 12 (e.g., by piercing the septum of the tube of the fluid flow circuit 12 or via a luer connector), and then attach the fluid flow circuit 12 to the blood separation device 10 (optionally including fluid containers F1 - F7 suspended from weighing scales W1 - W6). The control unit 18 can perform an integrity check on the fluid flow circuit 12 to confirm that various components are properly connected and functioning. When the integrity check is successfully completed, a blood source is connected to the fluid flow circuit 12 (e.g., by venipuncture of a donor), and the fluid flow circuit 12 is primed (e.g., by physiological saline sent from the physiological saline bag F2 by the operation of one or more of the pumps P1 - P6 of the blood separation device 10).

[0065] When the fluid flow circuit 12 is prepared, blood separation is started. The stages of blood separation vary according to specific procedures.

[0066] According to one aspect of the present disclosure, the blood separation device 10 can be used to separate and collect both platelets and platelet - and substantially cell - free plasma from blood. The blood separation device 10 according to the present disclosure can be used in combination with the fluid flow circuit 12.

[0067] FIG. 2 is a schematic diagram of an exemplary fluid flow circuit 12 having a single blood access device (e.g., a single needle that draws blood from the same location and returns the separated blood components to the same location) that can be used to separate and collect only platelets or both platelets and plasma. The fluid flow circuit 12 includes the cassette 48 of the type shown in FIG. 3, and this cassette 48 connects various components of the fluid flow circuit 12. Various connections between the components of the fluid flow circuit 12 are shown in FIG. 2, and this figure also shows the fluid flow circuit 12 attached to the blood separation device 10.

[0068] The various valves V1 to V11 and pressure sensors A1 to A4 of the blood separation device 10, except for the pressure sensor A3, are used in combination with the fluid flow circuit 12 of FIG. 2 to separate and collect platelets or platelets and plasma. As will be described later, although the fluid may flow through the sensor station S3 associated with the pressure sensor A3, the pressure sensor A3 does not communicate with the control unit 18 to monitor the pressure at any position within the fluid flow circuit 12. Further, as will be described later, both the centrifuge 16 and the rotary membrane separator drive unit 14 are used to separate and collect blood into platelets or platelets and plasma.

[0069] In the first stage, blood is drawn from the blood source 2 into the fluid flow circuit 12. When the blood source 2 is a donor, the blood is drawn into the fluid flow circuit 12 through a single needle connected to the cassette 48 by the line L140. The line L140 may include a manual clamp 56 that is initially in a closed position to prevent the flow of fluid through the line L140. When starting the process, the operator can move the manual clamp 56 from the closed position to the open position so that the fluid flows through the line L140.

[0070] The blood is drawn into the line L140 by the donor pump P2 of the blood separation device 10. The anticoagulant from the anticoagulant bag F1 is drawn through the line L141 by the action of the anticoagulant pump P1 and added to the blood at the junction of the lines L140 and L141.

[0071] In the illustrated embodiment, the valve V10 associated with the valve station C10 of the fluid flow circuit 12 is open so that the blood flows through the lines L140 and L142 and the sensor station S1 associated with the pressure sensor A1, while the valve V11 associated with the valve station C11 is closed to block the fluid flowing through the line L143. When the blood source is a living body (e.g., a donor), the pressure sensor A1 can communicate with the control unit 18 to monitor the pressure within the vein of the blood source.

[0072] The cassette 48 has two valve stations C1 and C2 downstream of the donor pump P2 and the line L144. The valve V2 associated with the valve station C2 is closed to prevent the flow through the line L145, and the valve V1 associated with the valve station C1 is open to allow the flow through the line L146. Blood flows through the line L146 associated with the open valve V1 to the junction, where a part of the blood is sent to the processing bag F3 through the line L147 and the sensor station S3 associated with the non-active pressure sensor A3, and the rest is sent to the centrifuge pump P3 through the line L148, controlling the amount of blood sent to the centrifuge chamber 36 rather than the processing bag F3. In particular, the flow rate of the donor pump P2 is larger than the flow rate of the centrifuge pump P3, and the difference is equal to the flow rate of the blood to the processing bag F3. The flow rate can be selected so that the processing bag F3 is partially or completely filled with blood at the end of the collection stage.

[0073] The blood sent out through the line L148 by the centrifuge pump P3 passes through the line L149, the air trap 62, and the sensor station S2 associated with the pressure sensor A2 (which monitors the pressure in the centrifuge chamber 36 in conjunction with the control unit 18 of the blood separation device 10), and then reaches the centrifuge chamber 36 of the fluid flow circuit 12. The centrifuge 16 of the blood separation device 10 operates the centrifuge chamber 36 to separate the blood in the centrifuge chamber 36 into platelet-rich plasma and concentrated red blood cells as described above. In one embodiment, the centrifuge chamber 36 rotates at a nominal 4,500 rpm, but the specific rotational speed may vary depending on the flow rate of the fluid entering and leaving the centrifuge chamber 36.

[0074] The concentrated red blood cells exit the centrifuge chamber 36 via the line L150 and flow into the return bag F4 through the line L151. In one embodiment, the concentrated red blood cells pass through the centrifuge fluid sensor M1 when exiting the centrifuge chamber 36. The centrifuge fluid sensor M1 can detect the hematocrit of the concentrated red blood cells exiting the centrifuge chamber. The white blood cells are either retained in the centrifuge chamber 36 or exit with the red blood cells.

[0075] By the interlocking operation of the recirculation pump P5 and the PRP pump P4 of the blood separation device 10, platelet-rich plasma is drawn out from the centrifugation chamber 36 through the line L152. The platelet-rich plasma passes through the centrifugal fluid sensor M1 and the line L152 and reaches the junction, which branches into lines L153 and L154. The centrifugal fluid sensor M1 can detect the concentration of platelets in the platelet-rich plasma. The recirculation pump P5 is associated with the line L153, redirects a part of the platelet-rich plasma towards the junction, and there it is mixed with the blood in the line L148 being conveyed to the centrifugation chamber 36 by the centrifugal pump P3. By recirculating a part of the platelet-rich plasma together with the inflowing blood into the centrifugation chamber 36, the hematocrit value of the blood entering the centrifugation chamber 36 may decrease, and the separation efficiency may be improved. With such a configuration, the flow rate of the fluid entering the centrifugation chamber 36 becomes equal to the sum of the flow rates of the centrifugal pump P3 and the recirculation pump P5.

[0076] The platelet-rich plasma drawn out from the centrifugation chamber 36 to the line L153 by the recirculation pump P5 is immediately returned to the centrifugation chamber 36. Therefore, the bulk flow rate or net flow rate of the platelet-rich plasma exiting the centrifugation chamber 36 is equal to the flow rate of the PRP pump P4. Before reaching the rotary membrane separator 26, a part of the platelet-rich plasma conveyed through the line L154 by the PRP pump P4 passes through the sensor station S4 associated with the pressure sensor A4. The pressure sensor A4 can monitor the pressure of the rotary membrane separator 26.

[0077] There is a junction on the line L154 where it merges with the line L155. The valve V6 associated with the valve station C6 is closed to prevent the flow of fluid through the line L155, and the separated platelet-rich plasma is directed towards the rotary membrane separator 26. The valve V6 can be selectively opened as needed to pass all or part of the platelet-rich plasma through the line L155 and return it towards the return bag F4. As an example, the start of the procedure when separation is initiated and platelets have not yet exited the centrifugation chamber 36 can be mentioned. In this case, the fluid carried through the line L154 by the PRP pump P4 can be directed towards the return bag F4.

[0078] The rotary membrane separator drive unit 14 of the blood separation device 10 operates the rotary membrane separator 26 to separate the platelet-rich plasma into two sub-components, namely, platelet-poor plasma and platelet concentrate. In one embodiment, the rotary membrane separator drive unit 14 rotates at about 1,500 rpm (or at a speed that varies according to the flow rate of the fluid entering and exiting the rotary membrane separator 26), and can separate, for example, the platelet-rich plasma entering the bottom of the rotary membrane separator 26 into plasma and platelets according to the above principle.

[0079] The plasma is sent out from the rotary membrane separator 26 via line L156 by the plasma pump P6 of the blood separation device 10. The valves V9, V8, V6, V5 associated with the valve stations C9, C8, C6, C5 are closed to prevent the flow through lines L157, L158, L155, L159, and the separated plasma passes through the valve station C4 associated with the open valve V4 along lines L156 and L160 and is sent to the return bag F4 (containing the separated red blood cells). On the way to the return bag F4, the plasma passes through the rotor outlet sensor M2, which can cooperate with the control unit 18 to determine one or more characteristics of the plasma, such as the amount of cellular blood components in the plasma and / or whether the plasma is hemolytic and / or lipemic.

[0080] The platelet concentrate is conveyed from the rotary membrane separator 26 via line L161. In one embodiment, since there is no pump associated with line L161, instead, the flow rate of platelets exiting the rotary membrane separator 26 is equal to the difference between the flow rates of the PRP pump P4 and the plasma pump P6. In one embodiment, the platelet concentration in the platelet concentrate can be optically measured by the sensor M4 (if present).

[0081] The valve V8 associated with valve station C8 is closed, preventing the flow of fluid through line L158, thereby directing the flow of platelets along lines L161 and L162, through valve station C7 associated with the open valve V7, and into platelet concentration bag F6. The valve V8 associated with valve station C8 is selectively opened, if necessary, to allow fluid to flow through line L158 to the junction, where plasma flowing through line L156 is added to return bag F4.

[0082] The collection phase may continue until the amount of blood collected from the blood source reaches the target amount, or until the processing bag F3 is filled to a specific level (determined by a weighing scale from which the processing bag F3 is suspended during processing), or until some other condition is met.

[0083] During the collection phase, control unit 18 can continuously estimate the platelet concentration (C donor ) of the donor's circulating blood based on values obtained by various sensors and scales, and other inputs related to the system, and the equations described herein. By estimating the platelet concentration of the donor's circulating blood during the blood processing procedure, pre-count measurement of platelets is unnecessary. Further, by continuously monitoring C donor , control unit 18 can be programmed to issue an alarm or warn the user if C donor falls below a predetermined limit, for example, 100e3 platelets / μL. In one embodiment, if C donor falls below the predetermined limit, control unit 18 can warn the user and / or automatically terminate the procedure.

[0084] When the collection phase is complete, the system transitions to one of two return phases, depending on whether only platelets are collected or both platelets and plasma are collected. At least a portion of at least one of the separated blood components is transported to a recipient (which may be the blood source), and collection of platelets or both platelets and plasma continues.

[0085] At the return stage of the procedure where only platelets are collected, the anticoagulant pump P1 stops drawing the anticoagulant from the anticoagulant bag F1. The valve V10 associated with the valve station C10 closes to prevent the flow of fluid through the line L142, and the valve V11 associated with the valve station C11 opens to allow the flow of fluid through the line L143. The valve V2 associated with the valve station C2 also opens to allow the flow of fluid through the line L145, and the valve V1 associated with the valve station C1 closes to prevent the flow of fluid through the line L146.

[0086] With the valves arranged in this way, the donor pump P2 reverses direction so that it can convey the contents of the return bag F4 to the recipient through the same needle used to draw blood into the fluid flow circuit 12. The return fluid (red blood cells and plasma) is pumped into line L163 via lines L151 and L145, the valve station C2 associated with the open valve V2, line L144, and the sensor station S1 associated with the pressure sensor A1. The return fluid moves along line L163, passes through the return line filter 58 and the air detector M3, and travels until it reaches the junction connecting lines L163 and L164 (which leads to the saline bag F2). Closing the valve V3 associated with the valve station C3 prevents the flow of fluid through line L164, and the return fluid continues along line L163, passes through the valve station C11 associated with the open valve V11, and is sent to the recipient along lines L143 and L140.

[0087] While the fluid is being conveyed to the recipient, the blood in the processing bag F3 functions as a blood supply to the centrifuge 16. When the system transitions to this return phase, the centrifugal pump P3 remains unchanged and separation continues in the same manner as described in the collection phase until the processing bag F3 is empty (i.e., the blood is separated into red blood cells and platelet-rich plasma in the centrifuge chamber 36, the red blood cells flow from the centrifuge chamber 36 to the return bag F4, the platelet-rich plasma flows to the rotary membrane separator 26 for separation, the separated platelets are collected, and the plasma is directed towards the return bag F4). Thus, the system components downstream of the centrifugal pump P3 are "blind" as to whether the system is in the collection phase or this return phase. It will be appreciated that the method described herein is preferable to batch processing (where the blood is separated only during the collection phase and not during the return phase) because separation and collection are performed continuously, reducing the time required to complete the procedure. Further, by continuously processing the blood in the centrifuge chamber 36, the interface between the separated red blood cells and platelet-rich plasma is maintained, whereas in the return phase of batch processing, the position of the interface is lost and the interface needs to be re-established for each suction / separation phase, further increasing the time required for the procedure.

[0088] It can be seen that the separated plasma and red blood cells are conveyed to the return bag F4 simultaneously with the contents of the return bag F4 being conveyed to the recipient. The operating speed of the donor pump P2 is faster than the speed at which the plasma and red blood cells are conveyed to the return bag F4, and the return bag F4 can be emptied during this return phase even while separation continues. When the processing bag F3 and / or the return bag F4 becomes empty, the system can return to the collection phase or transition to the final phase.

[0089] The return phase when collecting platelets and plasma is the same as the return phase when collecting only platelets. The main difference is that when collecting platelets and plasma, the valve V5 associated with valve station C5 opens to allow the flow through line L159, while the valve V4 associated with valve station C4 closes to block the flow through line L160, so that the separated plasma exiting the rotary membrane separator 26 is sent through line L159 associated with the open valve V5 to the plasma bag F9 instead of the return bag F4. The valves can be arranged in that way throughout the return phase, or the states of valves V4 and V5 can be reversed in part of the phase (thereby sending the separated plasma to the return bag F4 instead of the plasma bag F5), depending on the amount of plasma to be collected.

[0090] When the in - process bag F3 and / or the return bag F4 become empty during processing, the system can return to the collection phase or transition to the final phase.

[0091] When the target amount of platelets (e.g., a single - treatment dose of 3.3e11 platelets) or the target amount of platelets and plasma is collected, the blood source / recipient is disconnected from the fluid flow circuit 12, and the system can transition to the final phase where platelet additive solution is added to the collected platelets. This is done by operating with the valves V9 and V7 associated with valve stations C9 and C7 (respectively) open to allow the flow through lines L157 and L162, and with the valves V8, V6, V5, and V4 associated with valve stations C8, C6, C5, and C4 (respectively) closed to block the flow through lines L158, L155, L159, and L160. With the valves arranged in this way, the plasma pump P6 draws the platelet additive solution from the PAS bag F7 through line L157, passes through valve station C9 associated with the open valve V9, line L156, rotor outlet sensor M2, rotary membrane separator 26, lines L161 and L162, and valve station C7 associated with the open valve V7, and operates to inject it into the platelet concentrate bag F6.

[0092] In one embodiment, the control unit 18 can continuously estimate the platelet concentration (C donor ) of the donor's circulating blood throughout the blood treatment procedure.

[0093] It should be understood that the devices, fluid circuits, and procedures described herein are illustrative and not limiting. The method of estimating the platelet concentration (C donor ) of the donor's circulating blood throughout the blood treatment procedure can be used in various blood treatment devices and procedures without departing from the scope of the present disclosure. For example, the blood separation device 10 can be used in a fluid circuit equipped with a pair of blood access devices (e.g., needles) for separating and collecting platelets or both platelets and plasma from the blood. This enables a single step in which blood is simultaneously collected from a blood source, processed, and a portion of at least one separated component is transported to a recipient. A more detailed disclosure of the double-needle fluid circuit and procedure is disclosed in the previously incorporated U.S. Patent No. 11,465,160. Therefore, the control unit 18 and the method of estimating C donor described herein can be used in any known blood treatment device and procedure without departing from the scope of the present disclosure.

[0094] Other aspects The methods and systems described herein include additional aspects including, but not limited to, the following.

[0095] Aspect 1 A system for collecting platelets, comprising a reusable hardware unit including a separator, a disposable fluid circuit configured to be associated with the reusable hardware unit, and a control unit configured to estimate the platelet concentration (C donor ) of the donor's circulating blood.

[0096] Aspect 2 C donor is the platelet concentration (C wbcentThe system according to aspect 1, which is based on the platelet concentration C in the collected whole blood entering the separator and the percentage of the collected whole blood (WB%) in the separator inlet line.

[0097] Aspect 3 C donor is obtained by determining the product of the platelet concentration C in the collected whole blood entering the separator and the percentage of the collected whole blood (WB%) in the separator inlet line, and C wbcent = C donor × WB%, the system according to aspect 2. wbcent × WB%, the system according to aspect 2.

[0098] Aspect 4 WB% is obtained by dividing the amount of the collected whole blood in the separator inlet line by the total amount of the collected whole blood and other fluids in the separator inlet line, the system according to aspect 2.

[0099] Aspect 5 The other fluid is an anticoagulant, the system according to aspect 3.

[0100] Aspect 6 WB% is obtained by dividing the percentage of the collected whole blood by the sum of the percentage of the collected whole blood (WB ratio) and the percentage of the anticoagulant, and WB% = WB ratio / (WB ratio + anticoagulant ratio), the system according to aspect 4.

[0101] Aspect 7 C wbcent is based on the platelet concentration of the separated platelet-rich plasma (C prp ) and the hematocrit (H wbcent ) of the collected whole blood entering the separator, the system according to any one of aspects 2 to 6.

[0102] Aspect 8 C prp is measured by an optical sensor, the system according to aspect 7.

[0103] Aspect 9 C wbcent is determined by the following formula, the system according to aspect 7 or aspect 8. Cwbcent =C prp ×(1 - H wbcent )

[0104] Aspect 10 H wbcent is based on the flow rate (Q rbc ) of the separated red blood cells flowing out of the separator, the flow rate (Q wbcent ) of the collected whole blood flowing into the separator, and the hematocrit (H rbc ) of the separated red blood cells flowing out of the separator, and is the system according to any one of Aspects 7 to 9.

[0105] Aspect 11 H wbcent is, and H rbc is determined by dividing the product of H rbc and Q wbcent by Q wbcent =(H rbc ×Q rbc ) / Q wbcent is, and is the system according to Aspect 10.

[0106] Aspect 12 Q rbc is based on the flow rate (Q wbcent ) of the collected whole blood flowing into the separator and the flow rate (Q prp ) of the separated platelet - rich plasma flowing out of the separator, and is the system according to Aspect 10 or Aspect 11.

[0107] Aspect 13 Q wbcent is based on the pump speed of the separation pump, and Q prp is based on the pump speed of the platelet - rich plasma pump, and is the system according to Aspect 12.

[0108] Aspect 14 Q wbcent and Q prp are predetermined values, and is the system according to Aspect 13.

[0109] Aspect 15 Q rbc is the flow rate (Qwbcent ) from which the flow rate (Q prp ) of the separated platelet-rich plasma flowing out of the separator is subtracted, and Q rbc =Q wbcent -Q prp is the system according to aspect 12 or aspect 13.

[0110] Aspect 16 H rbc is a predetermined value, the system according to any one of aspects 10 to 15.

[0111] Aspect 17 H rbc is determined by an optical sensor, the system according to any one of aspects 10 to 15.

[0112] Aspect 18 H rbc is determined based on the flow rate of the separator and the centrifugal force of the separator, the system according to any one of aspects 10 to 15.

[0113] Aspect 19 The control unit is configured to determine C wbcent , WB%, C prp , H wbcent , H rbc , and Q rbc is the system according to any one of aspects 2 to 18.

[0114] Aspect 20 The control unit is configured to estimate the platelet concentration (C donor ) in the donor's circulating blood by the following formula, the system according to any one of aspects 2 to 19. C donor =(C prp ×WB%)×(1-(H rbc ×Q rbc )) / Q wbcent ))

[0115] Aspect 21 The system according to any one of aspects 2 to 20, wherein the separator is a centrifuge.

[0116] Aspect 22 A method for processing whole blood from a donor, comprising the steps of collecting whole blood from the donor, separating the collected whole blood into blood components including separated platelets, collecting the separated platelets, and estimating the platelet concentration (C donor ) of the donor's blood during processing.

[0117] Aspect 23 Further comprising connecting the donor to a blood processing system, the processing system comprising a reusable hardware unit including a separator, a disposable fluid circuit configured to be associated with the reusable hardware unit, and a control unit configured to estimate the platelet concentration (C donor ) of the donor's circulating blood. The method according to aspect 22.

[0118] Aspect 24 C donor is based on the platelet concentration (C wbcent ) in the collected whole blood entering the separator and the proportion (WB%) of the collected whole blood in the separator inlet line. The method according to aspect 22 or aspect 23.

[0119] Aspect 25 C donor is obtained by determining the product of the platelet concentration C wbcent in the collected whole blood entering the separator and the proportion (WB%) of the collected whole blood in the separator inlet line, and C donor = C wbcent × WB%. The method according to aspect 24.

[0120] Aspect 26 WB% is obtained by dividing the amount of whole blood collected in the separator inlet line by the total amount of the whole blood and other fluids collected in the separator inlet line. The method according to aspect 25.

[0121] Aspect 27 The method according to aspect 26, wherein the other fluid is an anticoagulant.

[0122] Aspect 28 The method according to aspect 27, wherein WB% is obtained by dividing the portion of whole blood collected (WB ratio) by the sum of the ratio of whole blood collected and the ratio of anticoagulant, and WB% = WB ratio / (WB ratio + anticoagulant ratio).

[0123] Aspect 29 C wbcent is based on the platelet concentration (C prp ) of the separated platelet-rich plasma and the hematocrit (H wbcent ) of the whole blood collected that enters the separator, and is the method according to any one of aspects 22 to 28.

[0124] Aspect 30 C prp is measured by an optical sensor, and is the method according to aspect 29.

[0125] Aspect 31 C wbcent is determined by the following formula, and is the method according to aspect 29 or aspect 30. C wbcent = C prp × (1 - H wbcent )

[0126] Aspect 32 H wbcent is based on the flow rate (Q rbc ) of the separated red blood cells flowing out of the separator, the flow rate (Q wbcent ) of the whole blood collected flowing into the separator, and the hematocrit (H rbc ) of the separated concentrated red blood cells flowing out of the separator, and is the method according to any one of aspects 29 to 31.

[0127] Aspect 33 H wbcent is the product of H rbc and Q rbc divided by Q wbcentDetermined by dividing by H wbcent =(H rbc ×Q rbc ) / Q wbcent The method according to aspect 32, wherein it is

[0128] Aspect 34 Q rbc is based on the flow rate of the collected whole blood flowing into the separator (Q wbcent ) and the flow rate of the separated platelet-rich plasma flowing out of the separator (Q prp ), the method according to aspect 32 or aspect 33.

[0129] Aspect 35 Q wbcent is based on the pump speed of the separation pump, and Q prp is based on the pump speed of the platelet-rich plasma pump, the method according to aspect 34.

[0130] Aspect 36 Q wbcent and Q prp are predetermined values, the method according to aspect 35.

[0131] Aspect 37 Q rbc is determined by subtracting the flow rate of the separated platelet-rich plasma flowing out of the separator (Q wbcent ) from the flow rate of the collected whole blood flowing into the separator (Q prp ), and Q rbc =Q wbcent -Q prp is the method according to aspect 34 or aspect 35.

[0132] Aspect 38 H rbc is a predetermined value, the method according to any one of aspects 32 to 37.

[0133] Aspect 39 H rbc is determined by an optical sensor, the method according to any one of aspects 32 to 37.

[0134] Aspect 40 H rbc is the method according to any one of Aspects 32 to 37, determined based on the separator flow rate and the separator acceleration.

[0135] Aspect 41 The control unit is C wbcent , WB%, C prp , H wbcent , H rbc , and Q rbc is configured to determine, and is the method according to any one of Aspects 23 to 40.

[0136] Aspect 42 The control unit is configured to estimate the platelet concentration (C donor ) in the donor's circulating blood by the following formula, and is the method according to any one of Aspects 23 to 41. C donor =(C prp ×WB%)×(1-(H rbc ×Q rbc )) / Q wbcent ).

[0137] Aspect 43 The separator is a centrifuge, and is the method according to any one of Aspects 23 to 42.

[0138] It will be understood that the above-described embodiments and examples illustrate some applications or principles of the subject matter 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 may be directed to combinations of features individually disclosed or claimed herein.

Claims

1. 1. A system for collecting platelets, comprising: a reusable hardware unit, the reusable hardware unit including a separator; and a disposable fluid circuit configured to be associated with the reusable hardware unit; Platelet concentration in the donor's circulating blood (C ｄｏｎｏｒ and a controller configured to estimate a time t of the time domain.

2. C ｄｏｎｏｒ is the platelet concentration in the collected whole blood entering the separator (C ｗｂｃｅｎｔ 2. The system of claim 1, wherein the measurement is based on the percentage of whole blood collected (WB%) in the separator inlet line.

3. C ｄｏｎｏｒ is the platelet concentration C in the collected whole blood entering the separator ｗｂｃｅｎｔ and the percentage of whole blood collected in the separator inlet line (WB%), C ｄｏｎｏｒ = C ｗｂｃｅｎｔ 3. The system of claim 2, wherein the WB % is 0.1×0.25×0.

5.

4. 3. The system of claim 2, wherein WB % is obtained by dividing the amount of whole blood collected in the separator inlet line by the combined amount of whole blood and other fluids collected in the separator inlet line.

5. The system of claim 3 , wherein the other fluid is an anticoagulant.

6. 5. The system of claim 4, wherein WB% is obtained by dividing the percentage of whole blood collected by the sum of the percentage of whole blood collected (WB percentage) and the percentage of anticoagulant, WB%=WB percentage / (WB percentage+anticoagulant percentage).

7. C ｗｂｃｅｎｔ The platelet-rich plasma (C ｐｒｐ ) and the hematocrit (H) of the collected whole blood entering the separator. ｗｂｃｅｎｔ 7. The system according to claim 2, wherein the system is based on

8. C ｐｒｐ The system of claim 7 , wherein is measured with an optical sensor.

9. C ｗｂｃｅｎｔ 9. The system of claim 7 or claim 8, wherein: C ｗｂｃｅｎｔ =C ｐｒｐ ×(1-H ｗｂｃｅｎｔ )

10. H ｗｂｃｅｎｔ is the flow rate of separated red blood cells exiting the separator (Q ｒｂｃ ) and the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) and the hematocrit (H) of the separated red blood cells flowing out of the separator. ｒｂｃ 10. The system according to claim 7, wherein the system is based on

11. H ｗｂｃｅｎｔ H ｒｂｃ and Q ｒｂｃ The product of Q ｗｂｃｅｎｔ is determined by dividing by H ｗｂｃｅｎｔ = (H ｒｂｃ ×Q ｒｂｃ ) / Q ｗｂｃｅｎｔ The system of claim 10 .

12. Q ｒｂｃ is the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) and the flow rate of the separated platelet-rich plasma flowing out of the separator (Q ｐｒｐ 12. The system according to claim 10 or 11, wherein the system is based on

13. Q ｗｂｃｅｎｔ is based on the pump speed of the separation pump, and Q ｐｒｐ 13. The system of claim 12, wherein the pump speed of the platelet-rich plasma pump is based on the pump speed of the platelet-rich plasma pump.

14. Q ｗｂｃｅｎｔ and Q. ｐｒｐ The system of claim 13 , wherein: is a predetermined value.

15. Q ｒｂｃ is the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) to obtain the flow rate (Q ｐｒｐ ) is determined by subtracting Q ｒｂｃ =Q ｗｂｃｅｎｔ -Q ｐｒｐ The system according to claim 12 or 13,

16. H ｒｂｃ 16. The system of claim 10, wherein: is a predetermined value.

17. H ｒｂｃ The system according to any one of claims 10 to 15, wherein is determined by an optical sensor.

18. H ｒｂｃ 16. The system of claim 10, wherein is determined based on a flow rate of the separator and a centrifugal force of the separator.

19. The control unit is C ｗｂｃｅｎｔ , WB%, C ｐｒｐ , H ｗｂｃｅｎｔ , H ｒｂｃ , and Q ｒｂｃ 19. The system of claim 2, configured to determine:

20. The control unit is configured to control the platelet concentration (C ｄｏｎｏｒ 20. The system of claim 2, configured to estimate the eigenvalue (E) of the input signal (E) according to the following formula: C ｄｏｎｏｒ =(C ｐｒｐ ×WB%)×(1-(H ｒｂｃ ×Q ｒｂｃ ) / Q ｗｂｃｅｎｔ ))

21. 21. The system of claim 2, wherein the separator is a centrifuge.

22. 1. A method for processing whole blood from a donor, comprising: Collecting whole blood from a donor; Separating the collected whole blood into blood components including separated platelets; collecting the separated platelets; During the process, the platelet concentration (C ｄｏｎｏｒ ) estimating

23. further comprising connecting the donor to a blood processing system; The processing system includes: a reusable hardware unit, the reusable hardware unit including a separator; a disposable fluid circuit configured to be associated with the reusable hardware unit; Platelet concentration in the donor's circulating blood (C ｄｏｎｏｒ and a controller configured to estimate the

24. C ｄｏｎｏｒ is the platelet concentration (C ｗｂｃｅｎｔ 24. The method of claim 22 or 23, wherein the concentration is based on the amount of collected whole blood (WB%) in the separator inlet line.

25. C ｄｏｎｏｒ is the platelet concentration C in the collected whole blood entering the separator ｗｂｃｅｎｔ and the percentage of whole blood collected in the separator inlet line (WB%), C ｄｏｎｏｒ = C ｗｂｃｅｎｔ The method of claim 24, wherein the WB % is 0.01×0.

01.

26. 26. The method of claim 25, wherein WB % is obtained by dividing the amount of whole blood collected in the separator inlet line by the combined amount of whole blood and other fluids collected in the separator inlet line.

27. 27. The method of claim 26, wherein the other fluid is an anticoagulant.

28. 28. The method of claim 27, wherein WB% is obtained by dividing the fraction of whole blood collected (WB fraction) by the sum of the fraction of whole blood collected and the fraction of anticoagulant, WB%=WB fraction / (WB fraction+anticoagulant fraction).

29. C ｗｂｃｅｎｔ is the platelet concentration (C ｐｒｐ ) and the hematocrit (H) of the collected whole blood entering the separator. ｗｂｃｅｎｔ 29. The method according to claim 22, wherein the method is based on

30. C ｐｒｐ The method of claim 29 , wherein is measured with an optical sensor.

31. C ｗｂｃｅｎｔ 31. The method of claim 29 or 30, wherein is determined by the following formula: C ｗｂｃｅｎｔ =C ｐｒｐ ×(1-H ｗｂｃｅｎｔ )

32. H ｗｂｃｅｎｔ is the flow rate of separated red blood cells exiting the separator (Q ｒｂｃ ) and the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) and the hematocrit (H) of the separated packed red blood cells flowing out of the separator. ｒｂｃ 32. The method according to claim 29, wherein the method is based on

33. H ｗｂｃｅｎｔ H ｒｂｃ and Q ｒｂｃ The product of Q ｗｂｃｅｎｔ is determined by dividing by H ｗｂｃｅｎｔ = (H ｒｂｃ ×Q ｒｂｃ ) / Q ｗｂｃｅｎｔ 33. The method of claim 32, wherein:

34. Q ｒｂｃ is the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) and the flow rate of the separated platelet-rich plasma flowing out of the separator (Q ｐｒｐ 34. The method of claim 32 or 33, wherein the method is based on

35. Q ｗｂｃｅｎｔ is based on the pump speed of the separation pump, and Q ｐｒｐ 35. The method of claim 34, wherein is based on the pump speed of the platelet-rich plasma pump.

36. Q ｗｂｃｅｎｔ and Q. ｐｒｐ 36. The method of claim 35, wherein: is a predetermined value.

37. Q ｒｂｃ is the flow rate of collected whole blood entering the separator (Q ｗｂｃｅｎｔ ) to obtain the flow rate (Q ｐｒｐ ) is determined by subtracting Q ｒｂｃ =Q ｗｂｃｅｎｔ -Q ｐｒｐ The method of claim 34 or claim 35, wherein

38. H ｒｂｃ 38. The method of any one of claims 32 to 37, wherein is a predetermined value.

39. H ｒｂｃ 38. The method of any one of claims 32 to 37, wherein is determined by an optical sensor.

40. H ｒｂｃ 38. The method of any one of claims 32 to 37, wherein is determined based on the separator flow rate and the separator acceleration.

41. The control unit is C ｗｂｃｅｎｔ , WB%, C ｐｒｐ , H ｗｂｃｅｎｔ , H ｒｂｃ , and Q ｒｂｃ 41. The method of any one of claims 23 to 40, configured to determine:

42. The control unit is configured to control the platelet concentration (C ｄｏｎｏｒ 42. The method according to claim 23, wherein the method is configured to estimate the following: C ｄｏｎｏｒ =(C ｐｒｐ ×WB%)×(1-(H ｒｂｃ ×Q ｒｂｃ ) / Q ｗｂｃｅｎｔ ))。

43. 43. The method of any one of claims 23 to 42, wherein the separator is a centrifuge.

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