Adjustment of fluid cell concentration measurement

Abstract

This disclosure relates to the adjustment of the measurement of cellular concentration in a fluid determined by a sensor. [Solution] The biofluid processing apparatus 10 includes a pump system and a valve system, a control unit, and an optical detection assembly. During the execution of the biofluid processing procedure, the control unit controls the operation of the pump system and the valve system to separate the cell-containing fluid from the blood of the blood supply source, and further controls the optical detection assembly to irradiate the cell-containing fluid with light. The control unit receives a signal from the optical detection assembly indicating the intensity of the light transmitted through the cell-containing fluid. The control unit receives or calculates an adjustment coefficient derived from historical data reflecting a cell collection procedure previously performed on the same blood supply source from which the cells were collected. The control unit determines the adjusted cell concentration of the cell-containing fluid based at least in part on the signal from the photodetector and the adjustment coefficient.

Description

[Technical Field]

[0001] [Cross-reference of related applications] This application claims the benefits and priority of U.S. Provisional Patent Application No. 63 / 736,651, filed on 20 December 2024, the contents of which are incorporated herein by reference.

[0002] [Technical field] This disclosure relates to the determination of the cell concentration in a fluid. More specifically, this disclosure relates to the adjustment of the measurement of the cell concentration in a fluid determined by a sensor. [Background technology]

[0003] Currently, various blood processing systems make it possible to collect specific blood components from a blood source, rather than whole blood. Typically, in such systems, whole blood is drawn from the blood source, specific blood components or elements are separated, removed, and collected, and the remaining blood components are returned to the blood source.

[0004] According to one approach, whole blood can be separated into red blood cells and platelet-concentrated plasma, and the platelet-concentrated plasma can then be separated into platelet concentrate and platelet-poor plasma. In such cases, the platelet concentrate can be collected as a platelet product, and the platelet-poor plasma can be collected as a plasma product in a separate container or returned to the blood source.

[0005] According to one conventional approach, an optical detection assembly is used during the platelet separation and collection procedure to determine the platelet concentration in one of the fluids (e.g., platelet-concentrated plasma). A typical optical detection assembly includes a light source (e.g., a laser or light-emitting diode) configured to emit light into a fluid-containing container of a fluid flow circuit, and a photodetector (e.g., a photodiode) configured to receive the light emitted from the container. The photodetector transmits a signal to a control unit based on the received light, which uses the signal to determine the instantaneous platelet concentration of the fluid. The signal may be transmitted periodically or continuously from the photodetector to the control unit to keep it informed of the platelet concentration of the fluid throughout the procedure. The control unit may combine the measured platelet concentration with the measured volume of the collected platelet product to calculate the estimated platelet yield during and at the end of the procedure.

[0006] After the platelet collection procedure is completed, the collected platelet product can be analyzed (e.g., using a cell counter) to calculate the actual platelet yield. It has been found that the estimated platelet yield calculated by the control unit may differ from the actual platelet yield (by comparing the actual platelet yield determined by the cell counter with the estimated platelet yield calculated by the control unit). Therefore, it is advantageous to improve the operation of the control unit so that the estimated platelet yield more closely matches the actual platelet yield of the collected platelet product. [Overview of the project]

[0007] Several aspects of the subject matter may be embodied individually or together in the apparatus and methods described and claimed below. These aspects may be used alone or in combination with other aspects described herein, and the joint description of these aspects is not intended to prevent the use of these aspects individually or the claiming of these aspects individually, as described in the claims appended to this specification.

[0008] In one embodiment, the biofluid processing apparatus includes a pump system, a valve system, a control unit programmed to control the operation of the pump system and valve system to perform a biofluid processing procedure on a blood source, and an optical detection assembly. The optical detection assembly includes a light source configured and directed to emit light onto the cell-containing fluid in a container during the biofluid processing procedure on the blood source, and a photodetector configured to receive at least a portion of the light emanating from the container. The control unit is further programmed to receive a signal from the photodetector during the biofluid processing procedure on the blood source, the signal from the photodetector indicating the intensity of the light received by the photodetector. The control unit receives or calculates an adjustment factor derived from historical data reflecting cell collection procedures previously performed on a blood source from which the same type of cells were collected. The control unit then determines the adjusted cell concentration of the cell-containing fluid, at least in part, based on the signal from the photodetector and the adjustment factor.

[0009] In another aspect, a biological fluid processing system includes a pumping system, a valve system, a control unit programmed to control the operation of the pumping system and the valve system to perform a biological fluid processing procedure on a blood source, and a biological fluid processing device having an optical detection assembly. The optical detection assembly includes a light source configured and oriented to emit light into a cell-containing fluid within a container during a biological fluid processing procedure on a blood source, and a light detector configured to receive at least a portion of the light exiting the container. The biological fluid processing system also includes a data management system programmed to store historical data reflecting cell collection procedures previously performed on blood sources from which the same type of cells were collected. The control unit is further programmed to receive a signal from the light detector during a biological fluid processing procedure on a blood source, the signal from the light detector indicating the intensity of the light received by the light detector. The control unit receives an adjustment factor derived from the historical data from the data management system or receives the historical data from the data management system and calculates the adjustment factor. The control unit then determines an adjusted cell concentration of the cell-containing fluid based at least in part on the signal from the light detector and the adjustment factor.

[0010] In yet another aspect, a method for implementing a control unit for performing a biological fluid processing procedure on a blood source is provided. The method includes separating a cell-containing fluid from blood from a blood source and emitting light through the cell-containing fluid. The method further includes receiving at least a portion of the light exiting the cell-containing fluid and generating a signal indicative of the intensity of the light exiting the cell-containing fluid. An adjustment factor is received or calculated, the adjustment factor being derived from historical data reflecting cell collection procedures previously performed on blood sources from which the same type of cells were collected. Thereafter, an adjusted cell concentration of the cell-containing fluid is determined based at least in part on the signal and the adjustment factor.

Brief Description of the Drawings

[0011] FIG. 1 is a perspective view of exemplary hardware components of a biological fluid processing system according to one aspect of the present disclosure.

[0012] FIG. 2 is a schematic diagram of an exemplary disposable component that can be attached to the hardware components of FIG. 1 to complete a biological fluid processing system according to one aspect of the present disclosure.

[0013] FIG. 3 is a perspective view of an exemplary optical detection assembly of the hardware components of FIG. 1, with its lid in the open position.

[0014] FIG. 4 is a perspective view of the optical detection assembly of FIG. 3, with the lid in the closed position.

[0015] FIG. 5 is a perspective view of selected components of the optical detection assembly of FIG. 3.

[0016] FIG. 6 is a flowchart showing an approach for adjusting an estimated platelet yield calculated by a control unit of the hardware components of FIG. 1 according to one aspect of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0017] The embodiments disclosed herein are for the purpose of providing an illustrative description of the subject matter. However, these are merely illustrative, and the subject matter can be embodied in various forms. Therefore, the specific details disclosed herein should not be construed as limiting the subject matter defined by the appended claims.

[0018] FIGS. 1 and 2 show the components of a biological fluid processing system embodying various aspects of the subject matter. In this specification, the use of a system for separating blood into two or more components and collecting at least one of the components is described, but it should be understood that the systems according to the present disclosure can be used to process various different biological fluids.

[0019] Generally speaking, the system comprises two main components: a durable and reusable biofluid processing device 10 (Figure 1) and a disposable fluid flow circuit 12 (Figure 2). The illustrated biofluid processing device 10 includes a rotating membrane separator drive unit 14, a centrifuge or centrifugal separator 16, additional components that control the fluid flow through the disposable fluid flow circuit 12, and a control unit 18 that coordinates the operation of the other components of the biofluid processing device 10 and executes the biofluid processing procedure. While the principles described herein may apply when using the biofluid processing device 10 of Figure 1, it should be understood that these same principles may also apply to other biofluid processing devices, including those employing a single separation technique or approach.

[0020] I. Durability of Biofluid Processing Equipment The biofluid processing device 10 (Figure 1) is configured as a durable item capable of long-term use. The biofluid processing device 10 in Figure 1 is merely an example of one possible configuration, and it should be understood that the biofluid processing device according to this disclosure may have different configurations.

[0021] In the illustrated embodiment, the biofluid processing apparatus 10 is embodied within a single housing or case 20. The illustrated case 20 includes a generally horizontal portion 22 (which may include an inclined or angled top surface to improve visibility and ergonomics) and a generally vertical portion 24. The rotating membrane separator drive unit 14 and the centrifuge 16 are shown to be incorporated within the generally horizontal portion 22 of the case 20, while the control unit 18 is shown to be incorporated within the generally vertical portion 24.

[0022] A Rotating Membrane Separator Drive Unit The biofluid processing apparatus 10 includes a spinner support, i.e., a rotating membrane separator drive unit 14, for housing a generally cylindrical rotating membrane separator 26 of the fluid flow circuit 12. U.S. Patent No. 5,194,145 (which is incorporated in its entirety by reference) describes an exemplary rotating membrane separator drive unit suitable for incorporation into the biofluid processing apparatus 10, but it should be understood that the rotating membrane separator drive unit 14 may have different configurations without departing from the scope of this disclosure.

[0023] The illustrated rotary membrane separator drive unit 14 has a base 28 configured to receive the lower part of the rotary membrane separator 26 and an upper end cap 30 to receive the upper part of the rotary membrane separator 26. Preferably, the upper end cap 30 is positioned directly above the base 28, thereby orienting the rotary membrane separator 26, which is received by the rotary membrane separator drive unit 14, vertically and defining the vertical axis on which the rotary membrane separator 26 rotates. While it may be advantageous for the rotating membrane separator drive unit 14 to orient the rotating membrane separator 26 vertically, within the scope of this disclosure, it is also included that the rotating membrane separator 26 may be positioned in a different orientation when it is attached to the biofluid processing device 10.

[0024] In one embodiment, either the base 28 or the upper cap 30 of the rotary membrane separator drive unit 14 is movable relative to the other, thereby allowing rotary membrane separators 26 of different sizes to be accommodated in the rotary membrane separator drive unit 14. For example, the upper cap 30 can be moved perpendicular to the base 28 and locked in a plurality of different positions. Each locked position corresponds to a rotary membrane separator 26 of a different size.

[0025] At least one of the base 28 and the upper cap 30 is configured to rotate one or more components of the rotating membrane separator 26 around 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 can be modified in various ways without departing from the scope of the present disclosure. In one embodiment, the rotating components of the rotating membrane separator 26 include at least one element configured to be actuated by a magnet (e.g., a metallic material), while the rotating membrane separator drive unit 14 includes a magnet (e.g., a series of magnetic coils or semicircular arcs). By modulating the magnetic field acting on the elements of the rotating membrane separator 26, the components of the rotating membrane separator 26 can be rotated in different directions and at different speeds. In other embodiments, different mechanisms may be employed to rotate the components of the rotating membrane separator 26.

[0026] 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 are preferably rotated at a speed sufficient to generate Taylor vortices in the gap between the rotating components and the stationary components of the rotating membrane separator 26 (or components rotating at different speeds). The fluid to be separated in the rotating membrane separator 26 flows through this gap, and the generation of Taylor vortices can dramatically improve filtration.

[0027] B Centrifuge The centrifuge 16 includes a centrifugal compartment 32 that receives the centrifugal chamber 36 of the fluid flow circuit 12, as well as other components of the centrifuge 16. Further details relating to the centrifuge are described in PCT Patent Application Publication No. WO2018 / 053217, which is incorporated herein by reference in its entirety.

[0028] A fluid (e.g., anticoagulated whole blood) is introduced into the centrifugation chamber 36 by an umbilicus, and as the centrifugation chamber 36 rotates, the fluid is separated into a layer of low-density components (e.g., platelet-concentrated plasma when separating blood) and a layer of high-density components (e.g., concentrated red blood cells). Components of the interface monitoring system are located in the centrifugation compartment 32 and can monitor the separation of the fluid in the centrifugation chamber 36. The interface monitoring system may include a light source 50 and a photodetector 52, the photodetector 52 being positioned and directed to receive at least a portion of the light emitted by the light source 50.

[0029] The orientation of each component of the interface monitoring system depends, at least in part, on the specific configuration of the centrifugal chamber 36. However, generally, the light source 50 emits a light beam (e.g., a laser beam) through the separated fluid components in the centrifugal chamber 36 (the centrifugal chamber 36 may be made of a material that substantially transmits light, or at least light of a certain wavelength, without absorbing it). Some of the light reaches the photodetector 52, which transmits a signal to the control unit 18 indicating the position of the interface between the separated fluid components. If the control unit 18 determines that the interface is in the wrong position (which may affect the separation efficiency of the centrifuge 16 and / or the quality of the separated fluid components), the control unit 18 can issue a command to the appropriate component of the biofluid processing device 10 to correct its operation and move the interface to the correct position.

[0030] C Other components of biofluid processing equipment In addition to the rotating membrane separator drive unit 14 and the centrifuge 16, the biofluid processing apparatus 10 may include other components compactly arranged to support fluid processing.

[0031] The generally horizontal portion 22 of the case 20 of the illustrated fluid processing apparatus 10 includes a cassette station 54 that houses a flow control cassette of the fluid flow circuit 12. 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 in its entirety), except that it is adapted to include additional components and functions. The illustrated cassette station 54 includes a plurality of clamps or valves V1-V9 (collectively referred herein as the “valve system” of the biofluid processing system 10), which move to multiple positions (e.g., between a retracted or lowered position and an activated or raised position) to selectively contact or otherwise interact with the corresponding valve stations of the flow control cassette of the fluid flow circuit 12. Depending on the configuration of the fluid flow circuit 12, its cassette may not include valve stations corresponding to each of the valves V1-V9 of the cassette station 54, in which case only some, but not all, of the valves V1-V9 are used in the fluid processing procedure.

[0032] In the operating position, valves V1 to V9 engage with the valve station to prevent fluid flow through that valve station (for example, by closing one or more ports associated with the valve station to prevent fluid flow through those ports). In the retracted position, valves V1 to V9 are separated from the valve station (or in contact with the valve station with less force than when in the operating position) to allow fluid flow through the valve station (for example, by opening one or more ports associated with the valve station to allow fluid flow through those ports). Additional clamps or valves V10 and V11 of the valve system are located outside the cassette station 54 and may interact with portions of the fluid flow circuit 12 that are valve stations (which may be the length of a tube) to selectively allow or prevent fluid flow through those portions. The valves V1 to V9 and their corresponding valve stations on the cassette station 54 and the cassette have different configurations and may perform different operations than valves V10 and V11 and the valve stations separated from the cassette station 54.

[0033] The cassette station 54 may include additional components such as pressure sensors A1-A4, which interact with the cassette's sensor station to monitor pressure at various points in the fluid flow circuit 12. For example, if the fluid source is a human donor, one or more of the pressure sensors A1-A4 may be configured to monitor the donor's venous pressure during blood collection and return. Other pressure sensors A1-A4 may monitor the pressure in the rotating membrane separator 26 and the centrifugal chamber 36. The control unit 18 receives signals from the pressure sensors A1-A4 indicating the pressure in the fluid flow circuit 12, and if the signals indicate a low or high pressure state, the control unit 18 may initiate an alarm or error state to notify the operator of the state and / or attempt to return the pressure to an acceptable range without operator intervention.

[0034] The biofluid processing device 10 may include a plurality of pumps P1-P6 (collectively referred to herein as the “pump system” of the biofluid processing device 10) to cause fluid to flow through the fluid flow circuit 12. The pumps P1-P6 may have different or similar configurations and / or perform similar or different functions. In the illustrated embodiment, the pumps P1-P6 are configured as peristaltic pumps, which may have a general configuration as described in U.S. Patent No. 5,868,696. Each pump P1-P6 engages with a different tube loop extending from the side of a flow control cassette and is selectively operated under the command of a control unit 18 to cause fluid to flow through a portion of the fluid flow circuit 12. In one embodiment, all or part of the cassette station 54 may be capable of translational movement in and out of the case 20, thereby enabling the tube loops to be automatically loaded into the associated pumps P1-P6. In other exemplary embodiments, instead of using a peristaltic pump, a pneumatic pump may be used, and an actuator incorporated into the cassette station 54 interacts with a appropriately configured portion of the fluid flow circuit 12 (for example, a pump station of a cassette attached to the cassette station 54) to transport fluid through the fluid flow circuit 12.

[0035] The illustrated biofluid processing apparatus 10 also includes a spinner inlet sensor M1 for determining one or more characteristics of a fluid flowing into a rotating membrane separator 26, which is mounted in a rotating membrane separator drive unit 14. If the fluid flowing into the rotating membrane separator 26 is whole blood (which may include anticoagulated whole blood), the spinner inlet sensor M1 may be configured to determine the hematocrit of the blood flowing into the rotating membrane separator 26. If the fluid flowing into the rotating membrane separator 26 is platelet-concentrated plasma, the spinner inlet sensor M1 may be configured to determine the platelet concentration of the platelet-concentrated plasma flowing into the rotating membrane separator 26. The spinner inlet sensor M1 may detect one or more characteristics of the fluid by optically monitoring the fluid flowing through the tubes of the fluid flow circuit 12, or by other suitable means. The control unit 18 may receive signals from the spinner inlet sensor M1 indicating one or more characteristics of the fluid flowing into the rotating membrane separator 26 and use these signals to optimize the fluid processing procedure based on those characteristics. If the characteristic is outside the acceptable range, the control unit 18 may initiate an alarm or error condition to notify the operator of the condition. Appropriate apparatus 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 in its entirety), but it should be understood that different methods may be used to monitor one or more characteristics of the fluid or fluid components flowing into the rotating membrane separator 26.

[0036] The illustrated biofluid apparatus 10 further includes a spinner outlet sensor M2 that houses a tube of a fluid flow circuit 12 for draining fluid components separated from a rotating membrane separator 26. The spinner outlet sensor M2 can monitor the separated fluid components and determine one or more of their characteristics, which can be done by optically monitoring the separated fluid components flowing through the tube or by other suitable methods. In one embodiment, separated plasma flows through the tube, in which case the spinner outlet sensor M2 may be configured to determine the amount of cellular blood components in the plasma and / or whether the plasma is hemolytic and / or lipometabolic. This can be done by using an optical monitor of the type described in U.S. Patent No. 8,556,793 (which is incorporated in whole by reference) that measures the optical concentration of the fluid in the relevant tube, or by other suitable apparatus and / or methods.

[0037] The illustrated fluid processing apparatus also includes an air detector M3 (e.g., an ultrasonic bubble detector) housing the tube of the fluid flow circuit 12 that carries fluid to the recipient. Whether the recipient is human (e.g., the same person acting as a blood source) or non-human (e.g., a storage bag or container), it may be advantageous to prevent air from reaching the recipient, so the air detector M3 may transmit a signal to the control unit 18 indicating the presence or absence of air in the tube. If the signal indicates the presence of air in the tube, the control unit 18 may initiate an alarm or error condition to notify the operator of the condition and / or take corrective action to prevent air from reaching the recipient (e.g., reversing the fluid flow through the tube or diverting the flow to a vent location).

[0038] The generally vertical portion 24 of Case 20 includes a plurality of volumetric measuring systems W1-W6 (six are shown, but more or fewer may be provided), each volumetric measuring system W1-W6 configured to be associated with one or more fluid containers F1-F7 (Figure 2) of the fluid flow circuit 12. Each volumetric measuring system W1-W6 is configured to operate in conjunction with a control unit 18 to measure the current volume of fluid in the associated fluid containers F1-F7 and to calculate the change in that volume between two or more time points. Individual volumetric measuring systems W1-W6 may have various configurations without departing from the scope of the present disclosure, including having two or more different configurations of volumetric measuring systems W1-W6. In one exemplary embodiment, the volumetric measuring systems W1-W6 are configured as, or may include, weight scales configured to support and measure the weight of fluid in the associated fluid containers F1-F7 (the measured weight is converted to volume by the components of the volumetric measuring systems W1-W6 or by the control unit 18). In other exemplary embodiments, the volume measurement systems W1-W6 may include one or more sensors configured to detect the volume and / or volume change of the fluid in the associated fluid containers F1-F7. Volume measurement systems including additional components (e.g., both weight scales and sensors) and / or alternative components may also be used without departing from the scope of the present disclosure.

[0039] Regardless of its specific configuration, each volume measurement system W1-W6 transmits a signal to the control unit 18 indicating the volume of fluid in the associated containers F1-F7 in order to track volume changes during the procedure. This allows the control unit 18 to process the incremental volume changes to derive the processing volume and flow rate, and subsequently generate signals to control processing events based at least partly on the derived processing volume. For example, the control unit 18 may diagnose leaks and blockages in the fluid flow circuit 12 and notify the operator.

[0040] The illustrated case 20 also includes a number of hooks or supports H1 and H2 that can support various components of the fluid flow circuit 12, or other articles of appropriate size and configuration.

[0041] D Control Unit According to one aspect of the present disclosure, the biofluid processing apparatus 10 includes a control unit 18 appropriately configured and / or programmed to control the operation of the biofluid processing apparatus 10. In one embodiment, the control unit 18 includes a main processing unit (MPU), which may include, for example, an Intel Pentium™ microprocessor, but other types of conventional microprocessors may also be used. In one embodiment, the control unit 18 may be mounted within a generally vertical portion 24 of the case 20 and provided adjacent to or integrated with an operator interface station (e.g., a touchscreen). In other embodiments, the control unit 18 and the operator interface station may be associated with a generally horizontal portion 22 or integrated into a separate device connected to the biofluid processing apparatus 10 (physically, by cables, etc., or wirelessly).

[0042] According to one aspect of the present disclosure, the control unit 18 is configured and / or programmed to perform at least one biofluid processing procedure, but more advantageously, it is configured and / or programmed to perform a variety of different biofluid processing procedures. For example, the control unit 18 may be configured and / or programmed to perform one or more of the following: a diunit erythrocyte collection procedure, a plasma collection procedure, a plasma / erythrocyte collection procedure, an erythrocyte / platelet / plasma collection procedure, a platelet collection procedure, and a platelet / plasma collection procedure.

[0043] More specifically, in carrying out these fluid processing procedures, the control unit 18 is configured and / or programmed to control one or more of the following tasks: drawing fluid into a fluid flow circuit 12 attached to the biofluid processing device 10; transporting the fluid to a separation location (i.e., into the rotating membrane separator 26 or centrifugal chamber 36 of the fluid flow circuit 12); separating the fluid into two or more components as desired; and transporting the separated components to a storage container, to a second location for further separation (e.g., into the rotating membrane separator 26 or centrifugal chamber 36 not used in the initial separation stage), or to a recipient (which may be the source from which the fluid was originally drawn).

[0044] This may include instructing the rotating membrane separator drive unit 14 and / or the centrifuge 16 to operate at a specific rotational speed, and instructing the pumps P1-P6 to transport fluid through a portion of the fluid flow circuit 12 at a specific flow rate. Therefore, even if it is stated herein that a particular component of the biofluid processing apparatus 10 (e.g., the rotating membrane separator drive unit 14 or the centrifuge 16) performs a particular function, it should be understood that such component is controlled by the control unit 18 to perform that function.

[0045] Before, during, and after the procedure, the control unit 18 may receive signals from various components of the biofluid processing device 10 (e.g., pressure sensors A1-A4) and monitor various aspects of the operation of the biofluid processing device 10 and the characteristics of the fluid flowing through the fluid flow circuit 12 and the separated fluid components. If the operation of any component and / or one or more characteristics of the fluid or separated fluid components are outside the acceptable range, the control unit 18 may initiate an alarm or error condition to notify the operator and / or perform actions to correct the condition. Appropriate corrective actions may include actions that depend on the specific error condition and may be performed with or without operator involvement.

[0046] For example, the control unit 18 may include an interface control module that receives signals from a photodetector 52 of the interface monitoring system. The signals received by the control unit 18 from the photodetector 52 indicate the position of the interface between the separated fluid components in the centrifugal chamber 36. If the control unit 18 determines that the interface is in the wrong position, it can issue commands to the appropriate components of the biofluid processing device 10 to correct their operation and move the interface to the correct position. For example, the control unit 18 may instruct one of the pumps P1 to P6 to introduce fluid into the centrifugal chamber 36 at a different flow rate, and / or to remove the separated fluid components from the centrifugal chamber 36 at a different flow rate, and / or to rotate the centrifugal chamber 36 by the centrifuge 16 at a different speed.

[0047] If an operator interface station is provided associated with the control unit 18, the operator interface station allows the operator to view information regarding the operation of the system on a screen or display unit (as alphanumeric and / or graphical images). The operator interface station also allows the operator to select applications executed by the control unit 18 and to change specific functional and performance criteria of the system. If configured as a touchscreen, the screen of the operator interface station can receive input from the operator via touch operation. If the screen is not a touchscreen, the operator interface station can receive input from the operator via a separate input device such as a computer mouse or keyboard. It is also within the scope of this disclosure that the operator interface station can receive input from both a touchscreen and a separate input device such as a keypad.

[0048] II. Disposable Fluid Flow Circuits The fluid flow circuit or flow set 12 (Figure 2) is intended to be sterile, single-use, and disposable. Before initiating a predetermined fluid processing procedure, the operator loads the various components of the fluid flow circuit 12 into the case 20 in association with the biofluid processing device 10. The control unit 18 executes the procedure based on a preset protocol, taking into account other inputs from the operator. Once the procedure is complete, the operator detaches the fluid flow circuit 12 from its association with the biofluid processing device 10. The portion of the fluid flow circuit 12 that holds the collected fluid components (e.g., collection container or bag) is removed from the case 20 and retained for storage, transfusion, or further processing. The remaining portion of the fluid flow circuit 12 is removed from the case 20 and discarded.

[0049] In the illustrated embodiment, the fluid flow circuit 12 includes a cassette, and other components of the fluid flow circuit 12 are connected to the cassette by flexible tubing. The other components may include a plurality of fluid containers F1 to F7. In the context of this disclosure, these containers include an anticoagulant container F1, a saline container F2, a processing container F3, a blood return container F4, a plasma collection container F5, a platelet collection container F6, and (optional) an additive container F7. Furthermore, the illustrated fluid flow circuit 12 includes one or more fluid source access devices (e.g., connectors or venipuncture needles for accessing blood in the fluid containers), a rotating membrane separator 26, and a centrifuge chamber 36.

[0050] The flow control cassette provides a centralized, programmable, integrated platform for all the pumping and numerous valve functions required for a given fluid handling procedure. In one embodiment, the cassette is configured similarly to the cassette of U.S. Patent No. 5,868,696, but is adapted to include additional components (e.g., more tube loops) and functionality.

[0051] During use, the cassette is mounted on the cassette station 54 of the biofluid processing device 10, with each sensor station aligned with the corresponding pressure sensors A1-A4 of the cassette station 54, and each valve station aligned with the corresponding valves V1-V9. Each valve station may define one or more ports that enable fluid communication between the valve station and other internal cavities (e.g., flow paths) of the cassette. As described above, each valve V1-V9 is movable to multiple positions (e.g., between a retracted or lowered position and an activated or raised position) under the command of the control unit 18, and selectively contacts the valve stations of the cassette. In the activated position, valves V1-V9 engage with the corresponding valve station, closing one or more of its ports to prevent fluid flow through those ports. In the retracted position, valves V1-V9 are separated from the corresponding valve station (or in contact with it with less force than in the activated position), opening one or more ports associated with the valve station, thereby allowing fluid flow through those ports.

[0052] Multiple tubular loops extend from the sides of the cassette and interact with pumps P1-P6 of the biofluid processing device 10. Different pumps P1-P6 may interact with the tubular loops of the cassette to perform different tasks during the procedure, but in the context of this disclosure, each of the pumps P1-P6 may be configured to function as an anticoagulant pump P1, a source pump P2, a centrifugal pump P3, an outlet pump P4, a recirculation pump P5, and a plasma pump P6. If the pumps P1-P6 are configured differently (e.g., as pneumatic pumps), the cassette may also be configured differently (e.g., a configuration with a pump station aligned with a pneumatic pump actuator) to allow the pumps P1-P6 to transport fluid through the cassette.

[0053] Additional tubing extends from the sides of the cassette and connects to other components of the flow set 12, including various fluid containers F1-F7, a rotating membrane separator 26, and a centrifugal chamber 36. The tubing connected to the centrifugal chamber 36 (which includes one inlet tube and two outlet tubes) can be bundled together as an umbilical.

[0054] Various additional components may be incorporated into the tubes extending from the cassette or into one of the cassette's cavities. For example, a manual clamp 56 may be associated with the line leading to the fluid supply source, a blood return line filter 58 (e.g., a microaggregate filter) may be associated with the line leading to the fluid receiver, and / or an air trap 62 may be positioned on the line upstream of the centrifugal chamber 36.

[0055] III. An Example of a Biofluid Processing Procedure An example of a biofluid processing procedure according to this disclosure is described below.

[0056] Prior to processing, the operator selects a desired protocol (e.g., using an operator interface station, if one is provided), thereby informing the control unit 18 how it should control other components of the biofluid processing device 10 during the procedure. This may involve first selecting one of several procedures that the system can perform, then selecting the type of procedure, and then selecting one or more parameters that will be active during the procedure. For example, this may involve selecting a platelet collection procedure from among various blood separation procedures, and then selecting the total volume of blood to be processed or the target volume of platelets to be collected during the procedure. If the fluid source is a biological source (e.g., a donor or patient), the operator can input various parameters of the source, such as sex, height, and weight. In one embodiment, the operator may also input one or more characteristics of the fluid to be processed (e.g., a pre-count of platelets).

[0057] When the control unit 18 receives the necessary input, it can proceed to the step of instructing the operator to attach the fluid flow circuit 12 to the biofluid processing device 10. If there are fluid containers that are not integrally formed with the fluid flow circuit 12 (e.g., platelet additive containers), they can be connected to the fluid flow circuit 12 (e.g., by puncturing the septum of the tubing of the fluid flow circuit 12 or via Luer connectors). The fluid flow circuit 12 is then attached to the biofluid processing device 10 (this includes, as appropriate, associating the fluid containers F1-F7 with volumetric measurement systems W1-W6). In one exemplary embodiment, each volumetric measurement system W1-W6 includes a weight scale associated with a hook for suspending the fluid container. In another exemplary embodiment, at least one volumetric measurement system W1-W6 includes a weight scale associated with a horizontal platform or surface, the container is placed on the platform or surface, and the weight scale transmits signals to the control unit 18 throughout the procedure indicating the weight of the container (and its contents). In other embodiments, the fluid container may be associated with a volumetric measuring system that omits a weight scale, but includes other means (e.g., one or more sensors) for measuring the volume of fluid in the container.

[0058] Once the fluid flow circuit 12 is fully installed in the biofluid processing device 10, the control unit 18 can proceed to perform an integrity check of the fluid flow circuit 12 to confirm that the various components of the fluid flow circuit 12 are properly connected and functioning. If the integrity check is successfully completed, a fluid source is connected to the fluid flow circuit 12 (for example, by connecting to a container of fluid that has already been collected, or by venipuncturing a donor). The fluid flow circuit 12 can then be primed (for example, by operating one or more of the pumps P1 to P6 of the biofluid processing device 10, using saline solution pumped from the saline solution container F2).

[0059] After the fluid flow circuit 12 is primed, fluid processing can be initiated. In the first stage of an exemplary platelet collection procedure, blood is drawn into the fluid flow circuit 12 from a blood source. If the blood source is a donor, the blood may be drawn into the fluid flow circuit 12 via a single needle connected to a cassette by line L1. Line L1 may include a manual clamp 56, which may be in a closed position initially to prevent fluid flow through line L1. When initiating processing, the operator may move the manual clamp 56 from the closed position to the open position to allow fluid flow through line L1.

[0060] Blood is drawn into line L1 by the supply pump P2 of the biofluid processing device 10. The anticoagulant from the anticoagulant container F1 is drawn through line L2 under the operation of the anticoagulant pump P1 and can be added to the blood at the junction of lines L1 and L2.

[0061] In the illustrated embodiment, valve V10 is open, allowing anticoagulated blood to flow through line L3 and the sensor station of the cassette associated with pressure sensor A1, while valve V11 is closed, preventing fluid flow through line L4. If the blood source is a living organism (e.g., a donor), pressure sensor A1 may communicate with control unit 18 to monitor the pressure in the vein of the blood source.

[0062] The cassette includes two valve stations downstream of the source pump P2. Valve V2 is closed to prevent flow through line L5, and valve V1 is open to allow flow through line L6. A portion of the blood is led to the processing container F3 through line L7 and the sensor station on the cassette associated with pressure sensor A3, while the remainder is led to the centrifugal pump P3 through line L8. The centrifugal pump P3 controls the amount of blood that is led to the centrifugation chamber 36 instead of the processing container F3. In particular, the flow rate of the source pump P2 is greater than the flow rate of the centrifugal pump P3, and the difference is equal to the flow rate of blood flowing into the processing container F3. The flow rate can be selected so that the processing container F3 is partially or completely filled with blood at the end of the blood collection phase.

[0063] Blood delivered through line L8 by centrifugal pump P3 passes through line L19, air trap 62, and a sensor station on a cassette associated with pressure sensor A2 (the pressure sensor A2 works in cooperation with the control unit 18 of the biofluid processing device 10 to monitor the pressure in the centrifugation chamber 36) before reaching the centrifugation chamber 36 of the fluid flow circuit 12. The centrifuge 16 of the biofluid processing device 10 operates the centrifugation chamber 36 to separate the blood in the centrifugation chamber 36 into platelet-concentrated plasma and concentrated red blood cells. In one embodiment, the centrifugation chamber 36 is nominally rotated at 4,500 rpm, but the specific rotation speed may vary depending on the flow rates of inflow and outflow into the centrifugation chamber 36.

[0064] Concentrated red blood cells are discharged from the centrifugation chamber 36 via line L10 and flow into the blood return container F4 via line L11. Platelet-concentrated plasma is drawn from the centrifugation chamber 36 via line L12 by the coordinated action of the recirculation pump P5 and outlet pump P4 of the biofluid processing device 10. The platelet-concentrated plasma moves through line L12 and, upon reaching a branching point, branches into lines L13 and L14. The recirculation pump P5 is associated with line L13 and recirculates a portion of the platelet-concentrated plasma, which is returned to a junction where it is mixed with blood in line L8 being transported to the centrifugation chamber 36 by the centrifugal pump P3. By recirculating a portion of the platelet-concentrated plasma along with the incoming blood to the centrifugation chamber 36, the hematocrit of the blood flowing into the centrifugation chamber 36 is reduced, and separation efficiency can be improved. With this configuration, the flow rate of the fluid flowing into the centrifugation chamber 36 is equal to the sum of the flow rates of the centrifugal pump P3 and the recirculation pump P5. Since the platelet-concentrated plasma drawn to line L13 by the recirculation pump P5 is immediately returned to the centrifugation chamber 36, the substantial or net outflow rate of platelet-concentrated plasma from the centrifugation chamber 36 is equal to the flow rate of the outlet pump P4.

[0065] Line L14 terminates at a junction where it merges with lines L15 and L16. Valve V6 is closed, preventing fluid flow through line L16, thereby directing the separated platelet-concentrated plasma to the rotating membrane separator 26 via line L15. Before reaching the rotating membrane separator 26, the portion of platelet-concentrated plasma transported through line L15 passes through sensor stations on a cassette associated with spinner inlet sensor M1 and pressure sensor A4. Spinner inlet sensor M1 can detect the platelet concentration in the platelet-concentrated plasma flowing into the rotating membrane separator 26, and pressure sensor A4 can monitor the pressure in the rotating membrane separator 26.

[0066] Valve V6 is normally closed, but can be selectively opened as needed to divert all or part of the platelet-concentrated plasma from line L14 to line L16, and further to the blood return container F4. For example, at the start of the procedure, when the separation has been initialized and platelets have not yet been discharged from the centrifuge chamber 36, the fluid being transported through line L14 by outlet pump P4 can be diverted to the blood return container F4.

[0067] The rotating membrane separator drive unit 14 of the biofluid processing device 10 operates the rotating membrane separator 26 to separate platelet-concentrated plasma into platelet-poor plasma ("plasma") and platelet concentrate ("platelets"). The plasma is delivered from the rotating membrane separator 26 via line L17 by the plasma pump P6 of the biofluid processing device 10. With valves V5, V6, V8 and V9 closed, the separated plasma is guided along line L18, through valve V4, to the blood return container F4 (along with concentrated red blood cells). On its way to the blood return container F4, the plasma passes through the spinner outlet sensor M2, which may work with the control unit 18 to determine one or more properties of the plasma, such as the amount of cellular blood components in the plasma and / or whether the plasma is hemolytic and / or lipidemia.

[0068] Platelet concentrate is transported from the rotating membrane separator 26 via line L19. Since line L19 is not associated with a pump, the flow rate of platelets discharged from the rotating membrane separator 26 is equal to the flow rate difference between the outlet pump P4 and the plasma pump P6. Valve V8 is closed, preventing fluid flow through line L20, thereby directing the platelet flow along line L19, through valve V7, and to the platelet collection container F6. If necessary, valve V8 is selectively opened to allow fluid flow through line L20, which can then merge with plasma heading towards the blood return container F4 via line L18 at the junction.

[0069] Depending on the volume of platelets to be collected, the blood collection stage described above may be repeated, and the blood collection stage may be performed alternately with a blood return stage in which the blood in the processing container F3 is separated in the centrifugation chamber 36, while the already collected blood components in the return container F4 are returned to the blood supply source. In such a blood return stage, the separated red blood cells and platelet-concentrated plasma may be led through various routes in the fluid flow circuit 12, but typically, an additional amount of platelets separated from platelet-poor plasma in the rotating membrane separator 26 (similar to the blood collection stage) is collected in the platelet collection container F6. Before ending the procedure, platelet additive from additive container F7 may be added to the collected platelets in the platelet collection container F6.

[0070] IV. Determination of instantaneous cell concentration and estimated cell yield As described above, the spinner inlet sensor M1 may be used in combination with the control unit 18 to determine one or more characteristics of the fluid flowing into the rotating membrane separator 26. On the other hand, the spinner outlet sensor M2 may be used to determine one or more characteristics of the fluid flowing out of the rotating membrane separator 26. Figures 3 to 5 show exemplary optical detection assemblies 100 that may be incorporated into the biofluid processing apparatus 10 to perform the function of the spinner inlet sensor M1 or the spinner outlet sensor M2. In one embodiment, two such optical detection assemblies 100 may be incorporated into the biofluid processing apparatus 10, one functioning as the spinner inlet sensor M1 and the other as the spinner outlet sensor M2. Although the optical detection assemblies 100 in Figures 3 to 5 are described as components of the biofluid processing apparatus 10 in Figure 1, it should be understood that the optical detection assemblies according to this disclosure may be incorporated into biofluid processing apparatuses of different configurations, or they may be provided as standalone devices not incorporated into a biofluid processing apparatus.

[0071] In the illustrated embodiment, the optical detection assembly 100 includes a light source 102 and a photodetector array 104, which are spaced apart to accommodate a container "B" between them. When the optical detection assembly 100 is used as a spinner inlet sensor M1, container B may be line L15 of the fluid flow circuit 12, and when the optical detection assembly 100 is used as a spinner outlet sensor M2, container B may be line L17 of the fluid flow circuit 12. It should be understood that the configuration of container B used in combination with the optical detection assembly 100 can be changed without departing from the scope of this disclosure. Container B only needs to be suitable for containing a fluid (including being configured so that the fluid flows through container B) and is formed of a material configured to transmit light emitted from the light source 102.

[0072] The illustrated optical detection assembly 100 includes a base 106 defining a slot or channel 108 configured to receive a container B. The channel 108 is configured to hold the container B in a desired orientation relative to the light source 102 and the photodetector array 104. The optical detection assembly 100 may further include a lid 110 to prevent external light from interfering with the analysis of the fluid in the container B (shown in Figures 3 and 4 as being hinged or pivoted to the base 106).

[0073] Light D emitted from the light source 102 (the light source 102 can be configured in various ways without departing from the scope of this disclosure) passes through the fluid in container B, enters container B, and then exits container B. Because the light exiting the turbid medium (e.g., blood or blood components) is scattered, the light may be detected at multiple locations rather than at a single location by a single photodetector (e.g., individual photodiodes). It has been found that different fluids (e.g., fluids with different cell concentrations) can produce exit light beams with different scattering patterns, and different individual photodetectors in the photodetector array 104 may receive different portions of the transmitted light. Generally, the photodetector located in the center of the photodetector array 104 tends to receive the strongest light, while the photodetectors located at both ends of the photodetector array 104 receive little to no light.

[0074] A control unit associated with the photodetector array 104 (which may be the control unit 18 of the biofluid processing device 10, or a separate dedicated control unit) receives signals from each individual photodetector of the photodetector array 104, each signal indicating the intensity of light received by the individual photodetector that transmitted the signal to the control unit. The set of signals received by the control unit from the individual photodetectors of the photodetector array 104 is referred to herein as a “scattering profile,” which can be understood as a graph or chart showing the voltage or intensity of the signals generated by each photodetector, arranged according to the position of the individual photodetectors in the photodetector array 104.

[0075] Cells in a fluid cause scattering of light, rather than allowing it to travel straight through the fluid and container B (along the initial direction of propagation). The more cells present in the fluid, the greater the scattering of light, and the more individual photodetectors receive at least some of the light, but their maximum intensity is relatively lower compared to the maximum intensity received by individual photodetectors when analyzing a fluid with a low cell concentration. In other words, light passing through a fluid with a low cell concentration is narrowly distributed or scattered, while light passing through a fluid with a high cell concentration is more broadly or more widely distributed or scattered. Therefore, by providing the photodetector array 104, the intensity of light received by multiple individual photodetectors (i.e., the light distribution or scattering profile) can be evaluated to determine the cell concentration of the fluid.

[0076] Once the control unit generates a scattering profile, various approaches can be used to extract data from the scattering profile, which can be used to determine the cell concentration of the fluid in question. For example, U.S. Patent Application Publication 2023 / 0243746 (which is incorporated herein by whole reference) describes how the maximum intensity or voltage and width of a portion of the scattering profile indicate the platelet concentration of the fluid. According to one approach described in U.S. Patent Application Publication 2023 / 0243746, the control unit determines the width of the scattering profile at an intensity value equal to a specific percentage of the maximum value. Once the maximum intensity or voltage and the width of the scattering profile at a predetermined percentage of the maximum value are determined, the control unit can determine the instantaneous platelet concentration of the fluid (for example, by accessing a library of values ​​that correlate the maximum intensity and scattering profile width with different platelet concentration values).

[0077] According to another exemplary approach described in U.S. Patent Application No. 18 / 938,376 (which is incorporated herein by reference in its entirety), the slope of a portion of the scattering profile can be correlated with the platelet concentration of the fluid. More specifically, the scattering profile has peaks at the locations corresponding to the individual photodetectors that received the most light passing through container B and the fluid inside it. The scattering profile has a “rising edge” to the left of the peaks and a “falling edge” to the right of the peaks. The rising edges include signals from individual photodetectors located to the left of the central photodetector, and the falling edges include signals from individual photodetectors located to the right of the central photodetector. As described above, photodetectors closer to the center of the photodetector array 104 tend to receive more light than photodetectors further from the center, so the rising edges have a positive slope (tend to show different slopes at different locations in the scattering profile) and the falling edges have a negative slope (also tend to show different slopes at different locations in the scattering profile). The magnitude of the rising and falling edge slopes of the scattering profile has been found to indicate the platelet concentration of the fluid being monitored by the optical detection assembly. Therefore, by determining the rising and / or falling edge slopes of the scattering profile (using any appropriate approach), the control unit can determine the instantaneous platelet concentration of the fluid in question (for example, by accessing a library of values ​​that correlate different platelet concentration values ​​with the rising or falling edge slopes of the scattering profile).

[0078] The optical detection assemblies 100 shown in Figures 3 to 5 and the platelet concentration determination techniques described above are merely illustrative, and different configurations of optical detection assemblies (e.g., those using a single photodetector instead of a photodetector array) and different cell concentration determination techniques may be used without departing from the scope of this disclosure.

[0079] Using the instantaneous cell concentration value, the control unit can calculate the estimated cell yield of the procedure using the following formula.

[0080] Yield Sensor =Σ(CInst ×Q PLTs ) [Formula 1]

[0081] Here, Yield Sensor This represents the estimated cell yield in the procedure.

[0082] C Inst This is the instantaneous cell concentration of the target fluid (e.g., platelet-concentrated plasma or platelet concentrate).

[0083] Q PLTS is a specific C Inst This is the flow rate of the target fluid during the period when it was detected. Q PLTS This can be determined by any appropriate approach. For example, it can be determined by monitoring the operating speed of a pump that transports the fluid of interest through a conduit monitored by the optical detection assembly 100, or by monitoring changes in the weight or volume of a cell receiving container (e.g., platelet collection container F6). It should be understood that using Equation 1 to calculate the estimated cell yield is merely illustrative, and other approaches may be used to calculate the estimated cell yield of a procedure without departing from the scope of this disclosure.

[0084] The estimated cell yield of the procedure can be stored in the central computer, data management system, or data processing system 64 of the biofluid processing system (Figure 1), which communicates with the control unit 18 of the biofluid processing device 10.

[0085] V Adjustment of instantaneous cell concentration and estimated cell yield As described above, after the platelet collection procedure is completed, the collected platelet product can be analyzed to calculate the actual platelet yield. The same applies to the procedures for collecting other blood cells. In one embodiment, the collected cell product can be analyzed using a cell counter 66 (FIG. 1), and the actual cell yield of the procedure can be calculated. For example, a type of cell counter commercially available from Sysmex Corporation in Kobe can be used to calculate the actual platelet yield, but cell counters with different configurations can also be used without departing from the scope of the present disclosure. Further, other approaches for calculating the actual cell yield of the procedure can be used without departing from the scope of the present disclosure.

[0086] Similar to the estimated cell yield, the actual cell yield of the procedure can be stored in the donor or blood source history file of the data management system 64 of the biological fluid processing system that communicates with the control unit 18 of the biological fluid processing device 10. In one embodiment, the data management system 64 can communicate with a plurality of biological fluid processing devices (which may have the same configuration as the biological fluid processing device 10 or different configurations) and / or blood donation / processing facilities. The data management system 64 can associate the estimated cell yield and the actual cell yield with the blood source of the procedure (e.g., a human blood donor), thereby recording and storing history data regarding a specific blood source that has been the subject of a plurality of cell separation / collection procedures using either the biological fluid processing device 10 and / or any other biological fluid processing device with which the data management system 64 communicates.

[0087] As described above, it has been found that the estimated platelet yield calculated by the control unit may be different from the actual platelet yield. The same applies to the procedures for collecting other blood cells. The cell yield estimation error (also referred to herein as the "adjustment factor") can be calculated using the following formula.

[0088] Yield Sensor-Error =((Yield Sensor -Yield Actual ) / Yield Sensor )×100 [Equation 2] Here, Yield Actual This represents the actual cell yield.

[0089] Yield Sensor C is determined by the control unit 18. Inst It is calculated using the value (and Q PLTS Given that we assume that there is no error in the decision, Yield Sensor-Error is C Inst It can be concluded that this is due to an error in the measurement of the value. Therefore, the Yield calculated by the control unit 18 of the biofluid processing device 10 Sensor To improve the value, the data management system 64 performs a subsequent procedure in which the same type of cells are collected from the same blood source, Yield Sensor-Error The data may be provided to the control unit 18. Alternatively, the data management system 64 may provide appropriate historical data to the control unit 18, and the control unit 18 itself may calculate the adjustment coefficient. Yield for the blood supply source Sensor-Error Using the values, the control unit 18 performs the cell collection procedure as usual, but each C is determined using the following formula. Inst The determination of the value can be adjusted.

[0090] C Inst-Adjusted =C Inst -C Inst ×Yield Sensor-Error [Formula 3] Here, C Inst-Adjusted This is the adjusted instantaneous cell concentration value.

[0091] The control unit 18 then performs various C Inst-Adjusted Using the values, the adjusted estimated cell yield is calculated using a modified version of Equation 1 below. Sensor-Adjusted It is possible to calculate this.

[0092] Yield Sensor-Adjusted =Σ(C Inst-Adjusted ×Q PLTs ) [Formula 4] This should result in an estimated cell yield that is closer to the actual cell yield of the procedure than the estimated cell yield calculated in the previous procedure for the blood supply source. Furthermore, by adjusting the instantaneous cell concentration value during the procedure, more efficient collection can be achieved, and on average, more cell product can be collected per procedure.

[0093] In the example above, the cell collection procedure is performed only twice for a specific blood source, therefore Yield Sensor-Error Only one value (i.e., the one calculated in the first iteration of the cell collection procedure) is available to adjust the operation of the control unit 18 in subsequent iterations. However, if the cell collection procedure is performed multiple times on the same blood source, and the data management system 64 stores the estimated cell yield (or adjusted estimated cell yield) and the actual cell yield for those procedures on that blood source, the Yield available before performing subsequent iterations of the procedure on that blood source is... Sensor-Error Multiple values ​​will exist. Figure 6 shows multiple historical yields for a specific blood source. Sensor-Error The Yield value is generated by the control unit 18, which uses this value to perform subsequent platelet collection procedures on the same blood source. Sensor-Adjusted An example approach to improve the accuracy of the values ​​is shown. Figure 6 is specific to the execution of a platelet collection procedure (and uses historical data from past platelet collection procedures to the same blood source), but the approach shown in Figure 6 can also be applied to the execution of procedures in which other types of cells are collected (using historical data from past procedures in which the same type of cells were collected from the same blood source).

[0094] In step 200 of the approach shown in Figure 6, the data management system 64 accesses the donor or blood source history file from its database, or the control unit 18 of the biofluid processing device 10 accesses the donor or blood source history file. For a predetermined number of past platelet collection procedures for the same blood source, the estimated platelet yield (step 202) and the actual platelet yield (step 204) are accessed. If the adjusted estimated platelet yield is stored in the file, instead of accessing the estimated platelet yield for that iteration, the adjusted estimated platelet yield for past platelet collection procedures may be accessed from the file.

[0095] The data management system 64 or control unit 18 then (in step 206) yields for each selected platelet collection procedure. Sensor-Error The calculation is performed. In Figure 6, the estimated platelet yield for the previous repeat of the procedure is used to calculate the yield. Sensor-Error While the calculation process is shown, it should be understood that if an adjusted estimated platelet yield for the replicate is available, it may be used instead.

[0096] Next, the data management system 64 or control unit 18 calculates the average adjustment coefficient yield by dividing the sum of the individual adjustment coefficients by the number of past platelet collection procedures, as shown in step 208. Sensor-Error-Avg Calculate.

[0097] Subsequently, the control unit 18 uses the average adjustment coefficient to control each C Inst While adjusting the value determination (steps 210 and 212), perform subsequent iterations of the platelet collection procedure to the same blood source as usual.

[0098] Throughout the procedure, the control unit 18 continues to calculate and update the adjusted estimated platelet yield (step 214). After updating the adjusted estimated platelet yield, the control unit 18 checks whether the procedure is complete (step 216). If the procedure is not complete (step 218), the control unit 18 continues to calculate the adjusted instantaneous platelet concentration (steps 210 and 212) and update the adjusted estimated platelet yield (step 214). If the procedure is complete (step 220), the control unit 18 determines the adjusted estimated platelet yield for that procedure and transmits it to the data management system 64 (step 222). This value is stored in the blood source history file. After the procedure is complete, the collected platelet product may be analyzed (e.g., using a cell counter 66) to determine the actual platelet yield. This actual platelet yield is transmitted to the data management system 64 and may be stored in the blood source history file.

[0099] Regarding the example According to an example embodiment of the principle described herein, a platelet collection procedure is performed on a blood source that has previously been used in two platelet collection procedures.

[0100] In this example, the first previously executed step yielded the following value: Yield sensor = 6.4e11 platelets,

[0101] Yield Actual = 6.0e11 platelets, and

[0102] Yield Sensor-Error =((6.4e11-6.0e11) / 6.4e11)×100=6.25% (following Equation 2). As described above, the first two values ​​can be stored in the blood supply source history file of the data management system 64. The third value, on the other hand, can be calculated by the control unit 18 of the biofluid processing device 10 or the data management system 64 in order to perform a subsequent platelet collection procedure on the blood supply source.

[0103] In this example, the second previous platelet collection procedure performed yielded the following values.

[0104] Yield sensor = 6.2e11 platelets,

[0105] Yield Actual = 6.0e11 platelets, and

[0106] Yield Sensor-Error =((6.2e11-6.0e11) / 6.2e11)×100=3.23% (following Equation 2). The first two values, like the values ​​corresponding to the first procedure, can be stored in the same blood source history file in the data management system 64. The third value, on the other hand, can be calculated by the control unit 18 of the biofluid processing device 10 or the data management system 64 in order to perform a subsequent platelet collection procedure on that blood source.

[0107] As described above, once adjustment factors are calculated for the two past platelet collection procedures, the average adjustment factor can be calculated as follows. Yield Sensor-Error-Avg =(6.25%+3.23%) / 2=4.74% (according to the formula shown in step 208 of Figure 6). Similar to the adjustment coefficient, the average adjustment coefficient may be calculated by the data management system 64 and transmitted to the control unit 18 of the biofluid processing device 10 for use in executing subsequent platelet collection procedures for the blood supply source, or the control unit 18 itself may calculate the average adjustment coefficient.

[0108] When performing a subsequent platelet collection procedure on the blood supply source, the control unit 18 monitors the instantaneous platelet concentration C of the monitored fluid at a certain point in the procedure. Inst The concentration is determined to be 1550e3 particles / μL. Using the formula shown in step 212 of Figure 6, the adjusted instantaneous platelet concentration of the monitored fluid is calculated as follows:

[0109] C Inst-Adjusted=1550e3 / μL-1550e3 / μL×4.74%=1476.5e3 platelets / μL Subsequently, the control unit 18 calculates the adjusted estimated platelet yield using the adjusted instantaneous platelet concentration, as described above and as shown in step 214 of Figure 6. Once the procedure is complete, according to step 222 of Figure 6, the control unit 18 may transmit the final value of the adjusted estimated platelet yield to the data management system 64.

[0110] VII. Aspect Appearance 1 A biofluid processing apparatus comprising a pump system, a valve system, a control unit programmed to control the operation of the pump system and the valve system for performing a biofluid processing procedure on a blood source, and an optical detection assembly, wherein the optical detection assembly comprises a light source configured and directed to irradiate and direct light onto a cell-containing fluid in a container during a biofluid processing procedure on the blood source, and a photodetector configured to receive at least a portion of the light emitted from the container, wherein the control unit is programmed to receive a signal from the photodetector during a biofluid processing procedure on the blood source, the signal from the photodetector indicating the intensity of at least a portion of the light received by the photodetector, and to receive or calculate an adjustment coefficient derived from historical data reflecting a cell collection procedure previously performed on the blood source from which the cells were collected, and to determine an adjusted cell concentration in the cell-containing fluid in the container during a biofluid processing procedure on the blood source, at least in part based on the signal from the photodetector and the adjustment coefficient.

[0111] Appearance 2 A biofluid apparatus according to Embodiment 1, wherein the control unit is further programmed to calculate a adjusted estimated cell yield of a biofluid processing procedure for the blood supply source, the adjusted estimated cell yield being at least in part based on the adjusted cell concentration of the cell-containing fluid in the container.

[0112] Appearance 3 A biofluid apparatus according to Embodiment 1 or Embodiment 2, wherein the adjustment coefficient is at least partially based on the difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source and the actual cell yield in the cell collection procedure previously performed on the blood source.

[0113] Pattern 4 A biofluid apparatus according to Embodiment 3, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source and the actual cell yield in the cell collection procedure previously performed on the blood source.

[0114] Appearance 5 A biofluid apparatus according to any one of embodiments 1 to 4, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed with respect to the blood supply source from which the cells were collected.

[0115] Appearance 6 A biofluid apparatus according to embodiment 5, wherein the adjustment coefficient is at least in part based on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0116] Appearance 7 A biofluid apparatus according to embodiment 6, wherein the adjustment coefficient reflects the average percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0117] Appearance 8 A biofluid apparatus according to any one of Embodiments 1 to 7, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

[0118] Appearance 9 A biofluid processing system comprising a biofluid processing device, the biofluid processing device comprising a pump system, a valve system, a control unit programmed to control the operation of the pump system and the valve system to perform a biofluid processing procedure on a blood source, and an optical detection assembly, the optical detection assembly comprising a light source configured and directed to irradiate light onto a cell-containing fluid in a container during the biofluid processing procedure on the blood source, and a photodetector configured to receive at least a portion of the light emitted from the container, the biofluid processing device storing historical data reflecting cell collection procedures previously performed on the blood source from which the cells were collected. A biofluid processing apparatus comprising a data management system programmed to perform a biofluid processing procedure on the blood source, wherein the control unit further receives a signal from the photodetector during a biofluid processing procedure on the blood source, the signal from the photodetector indicating the intensity of at least a portion of the light received by the photodetector, and receives an adjustment coefficient derived from the data management system based on the historical data, or receives the historical data from the data management system and calculates the adjustment coefficient, and is programmed to determine an adjusted cell concentration of the cell-containing fluid in the container during a biofluid processing procedure on the blood source, at least in part based on the signal from the photodetector and the adjustment coefficient.

[0119] Appearance 10 A biofluid processing system according to embodiment 9, wherein the control unit is further programmed to calculate a adjusted estimated cell yield of a biofluid processing procedure for the blood supply source, the adjusted estimated cell yield being at least partially based on the adjusted cell concentration of the cell-containing fluid in the container.

[0120] Appearance 11 A biofluid processing system according to embodiment 9 or embodiment 10, wherein the adjustment coefficient is based at least in part on the difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

[0121] Appearance 12 A biofluid processing system according to embodiment 11, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

[0122] Appearance 13 A biofluid processing system according to any one of embodiments 9 to 12, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed on the blood source from which the cells were collected.

[0123] Appearance 14 A biofluid processing system according to embodiment 13, wherein the adjustment coefficient is based at least in part on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0124] Appearance 15 A biofluid processing system according to embodiment 14, wherein the adjustment coefficient reflects the average percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0125] Appearance 16 A biofluid processing system according to any one of embodiments 9 to 15, wherein the biofluid processing system further comprises a cell counter configured to determine the actual cell yield of a biofluid processing procedure for a blood source, and the data management system is programmed to store the actual cell yield of the biofluid processing procedure for the blood source.

[0126] Appearance 17 A biofluid processing system according to any one of embodiments 9 to 16, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

[0127] Appearance 18 A control unit implementation method for performing a biofluid processing procedure on a blood supply source, A step of separating cell-containing fluid from the blood from the blood supply source, The steps include irradiating the cell-containing fluid with light, A step of receiving at least a portion of the light emitted from the cell-containing fluid, A step of generating a signal indicating the intensity of at least a portion of the light emitted from the cell-containing fluid, A step of receiving an adjustment coefficient derived from historical data that reflects a cell collection procedure previously performed with respect to the blood supply from which the cells were collected, or a step of receiving the historical data and calculating the adjustment coefficient, A step of determining the adjusted cell concentration of the cell-containing fluid based at least in part on the signal and the adjustment coefficient, A control unit implementation method, including the above.

[0128] Appearance 19 A method according to embodiment 18, further comprising the step of calculating the adjusted estimated cell yield of the biofluid treatment procedure for the blood source, wherein the adjusted estimated cell yield is at least in part based on the adjusted cell concentration of the cell-containing fluid.

[0129] Appearance 20 A method according to embodiment 18 or embodiment 19, wherein the adjustment coefficient is based at least in part on the difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in a cell collection procedure previously performed on the blood source.

[0130] Appearance 21 A method according to Embodiment 20, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

[0131] Appearance 22 A method according to any one of embodiments 18 to 21, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0132] Appearance 23 A method according to embodiment 22, wherein the adjustment coefficient is at least in part based on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0133] Pattern 24 A method according to embodiment 23, wherein the adjustment coefficient reflects the mean percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

[0134] Appearance 25 A method according to any one of embodiments 18 to 24, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

[0135] It will be understood that the embodiments described above illustrate only some examples of the application of the principles of the present invention. Those skilled in the art will understand that numerous modifications are possible without departing from the spirit and scope of the subject matter of the claims, including combinations of features individually disclosed herein or described in the claims. For these reasons, it will be understood that the scope of the present invention is not limited to the above description but extends to the scope described in the following claims, and that the claims also apply to the features of the present invention, including combinations of features individually disclosed herein or described in the claims.

Claims

1. A biological fluid processing apparatus, Pump system and, Valve system and, A control unit programmed to control the operation of the pump system and the valve system in order to perform a biofluid processing procedure on a blood supply source, Equipped with an optical detection assembly, The optical detection assembly is During the biofluid processing procedure for the blood supply source, a light source configured and directed to irradiate the cell-containing fluid in the container with light, The container comprises a photodetector configured to receive at least a portion of the light emitted from the container, The control unit further, During the biofluid processing procedure for the blood supply source, a signal is received from the photodetector, and the signal from the photodetector indicates the intensity of at least a portion of the light received by the photodetector. The system receives or calculates an adjustment coefficient derived from historical data that reflects cell collection procedures previously performed on the blood source from which the cells were collected. A biofluid processing apparatus programmed to determine the adjusted cell concentration of the cell-containing fluid in the container during a biofluid processing procedure for the blood supply source, at least in part, based on the signal from the photodetector and the adjustment coefficient.

2. A biofluid apparatus according to claim 1, wherein the control unit is further programmed to calculate a adjusted estimated cell yield of a biofluid processing procedure for the blood supply source, the adjusted estimated cell yield being at least in part based on the adjusted cell concentration of the cell-containing fluid in the container.

3. A biofluid apparatus according to claim 1 or claim 2, wherein the adjustment coefficient is at least partially based on the difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source and the actual cell yield in the cell collection procedure previously performed on the blood source.

4. A biofluid apparatus according to claim 3, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source and the actual cell yield in the cell collection procedure previously performed on the blood source.

5. A biofluid apparatus according to claim 1 or claim 2, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

6. A biofluid apparatus according to claim 5, wherein the adjustment coefficient is at least in part based on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

7. A biofluid apparatus according to claim 6, wherein the adjustment coefficient reflects the average percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

8. A biofluid apparatus according to claim 1 or claim 2, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

9. A biofluid processing system, Includes a biological fluid processing device, The said biological fluid processing apparatus is Pump system and, Valve system and, A control unit programmed to control the operation of the pump system and the valve system in order to perform a biofluid processing procedure on a blood supply source, Including an optical detection assembly, The optical detection assembly is During the biofluid processing procedure for the blood supply source, a light source configured and directed to irradiate the cell-containing fluid in the container with light, The container includes a photodetector configured to receive at least a portion of the light emitted from the container, The aforementioned biological processing device is The system includes a data management system programmed to store historical data reflecting previously performed cell collection procedures for the blood source from which the cells were collected, The control unit further, During the biofluid processing procedure for the blood supply source, a signal is received from the photodetector, and the signal from the photodetector indicates the intensity of at least a portion of the light received by the photodetector. The adjustment coefficient derived based on the historical data is received from the data management system, or the historical data is received from the data management system and the adjustment coefficient is calculated. A biofluid processing apparatus programmed to determine the adjusted cell concentration of the cell-containing fluid in the container during a biofluid processing procedure for the blood supply source, at least in part, based on the signal from the photodetector and the adjustment coefficient.

10. A biofluid processing system according to claim 9, wherein the control unit is further programmed to calculate a adjusted estimated cell yield of a biofluid processing procedure for the blood supply source, the adjusted estimated cell yield being at least partially based on the adjusted cell concentration of the cell-containing fluid in the container.

11. A biofluid processing system according to claim 9 or claim 10, wherein the adjustment coefficient is at least in part based on the difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

12. A biofluid processing system according to claim 11, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

13. A biofluid processing system according to any one of claims 9 to 10, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

14. A biofluid processing system according to claim 13, wherein the adjustment coefficient is based at least in part on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

15. A biofluid processing system according to claim 14, wherein the adjustment coefficient reflects the average percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

16. A biofluid processing system according to any one of claims 9 to 10, wherein the biofluid processing system further comprises a cell counter configured to determine the actual cell yield of a biofluid processing procedure for a blood source, and the data management system is programmed to store the actual cell yield of the biofluid processing procedure for the blood source.

17. A biofluid processing system according to any one of claims 9 to 10, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

18. A control unit implementation method for performing a biofluid processing procedure on a blood supply source, A step of separating cell-containing fluid from the blood from the blood supply source, The steps include irradiating the cell-containing fluid with light, A step of receiving at least a portion of the light emitted from the cell-containing fluid, A step of generating a signal indicating the intensity of at least a portion of the light emitted from the cell-containing fluid, A step of receiving an adjustment coefficient derived from historical data that reflects a cell collection procedure previously performed with respect to the blood supply from which the cells were collected, or a step of receiving the historical data and calculating the adjustment coefficient, A step of determining the adjusted cell concentration of the cell-containing fluid based at least in part on the signal and the adjustment coefficient, A control unit implementation method, including the above.

19. A method according to claim 18, further comprising the step of calculating the adjusted estimated cell yield of the biofluid treatment procedure for the blood source, wherein the adjusted estimated cell yield is at least partially based on the adjusted cell concentration of the cell-containing fluid.

20. A method according to claim 18 or claim 19, wherein the adjustment coefficient is based at least in part on the difference between an estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

21. A method according to claim 20, wherein the adjustment coefficient reflects the percentage difference between the estimated cell yield or adjusted estimated cell yield in a cell collection procedure previously performed on the blood source from which the cells were collected and the actual cell yield in the cell collection procedure previously performed on the blood source.

22. A method according to any one of claims 18 to 19, wherein the adjustment coefficient is derived from historical data reflecting a plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

23. A method according to claim 22, wherein the adjustment coefficient is at least in part based on the mean difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

24. A method according to claim 23, wherein the adjustment coefficient reflects the mean percentage difference between the estimated cell yield or adjusted estimated cell yield and the actual cell yield in each of the plurality of cell collection procedures previously performed with respect to the blood source from which the cells were collected.

25. A method according to any one of claims 18 to 19, wherein the cells are platelets and the adjusted cell concentration is the adjusted platelet concentration.

Images