Notification system and apparatus for blood processing procedures

Abstract

The present invention provides a blood processing system, apparatus, and method that includes durable hardware components, disposable fluid flow circuits, and a control unit configured to provide alerts and / or notifications. [Solution] A blood processing system and apparatus including a control unit configured to monitor a blood processing procedure and provide one or more notifications based on events monitored during the blood processing procedure.

Description

Technical Field

[0001] The present disclosure relates to systems and devices for blood treatment procedures. More particularly, the present disclosure relates to blood treatment systems and devices configured to provide alerts and / or notifications to an operator during a blood treatment procedure.

Background Art

[0002] Currently, various blood treatment 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 a blood source, specific blood components or constituents are separated, removed, collected, and the remaining blood constituents are returned to the blood source. Removing only specific components is advantageous when the blood source is a human donor. This is because the time required for the donor's body to return to pre-donation levels is potentially shorter, and donations can be made more frequently than when whole blood is collected. As a result, the overall supply of blood components available for transfer and / or treatment procedures, such as plasma and platelets, increases.

[0003] Existing apheresis devices typically include various sensors and monitoring systems to track the progress of the procedure and ensure the safety and effectiveness of the blood separation process. For example, many apheresis devices monitor the flow rate, pressure, and composition of the blood as it passes through the device. If any of these parameters deviate from a pre-defined hard-coded operating range, the device may generate an alert or notification to warn the operator.

[0004] These hard-coded notification thresholds are typically set by the device manufacturer based on general guidelines and recommendations rather than being dynamically adjusted based on specific patient or donor characteristics, the type of procedure, or real-time trends in the monitored data. As a result, the notification system does not always provide the most relevant or timely alerts to the operator.

[0005] For example, one limitation of hardcoded alarm thresholds is their ability to notify the operator when updates to procedure objectives or donor parameters may be necessary. Such changes can significantly impact the target whole blood volume to be processed and the target procedure product and its volume. Near the end of the procedure, changes may no longer be feasible without negative consequences. These could include instability in the collection process due to changes in processing speed, large volumes of blood being returned to the donor in a short time, large volumes needing to be collected in a short time, and / or exceeding the donor safety limit, thus requiring immediate termination of the procedure.

[0006] Furthermore, conventional apheresis devices may be configured to notify the operator when the volume of residual whole blood to be processed reaches a hardcoded threshold, when a hardcoded minimum residual solution volume is reached, and / or when the procedure is nearing completion based on a hardcoded amount of target blood products collected. Because the procedure may involve variable processing speeds, alarms may occur at different times between steps. This variability reduces the effectiveness of the alarms because the operator may not be aware of how much time is actually remaining for that step or the entire procedure.

[0007] For example, if the predefined threshold for residual whole blood is 500 mL and the system is processing at 50 mL / min, the operator will be notified when there are 10 minutes remaining. However, if the processing rate is 100 mL / min, the notification will only be given when there are 5 minutes remaining.

[0008] Therefore, an improved notification system related to apheresis systems and devices is needed. [Overview of the Initiative]

[0009] In one embodiment, a blood processing system is provided. The blood processing system includes a reusable separator, which includes a separator and a disposable fluid circuit including a separation chamber and a plurality of containers. The disposable fluid circuit is configured to be associated with the reusable separator. The reusable separator includes a control unit configured to monitor a blood processing procedure and to provide one or more notifications based on monitored events during the blood processing procedure.

[0010] In another embodiment, a blood processing device is provided. The blood processing device includes a separator and a control unit configured to monitor the blood processing procedure and provide one or more notifications based on monitored events during the blood processing procedure. [Brief explanation of the drawing]

[0011] Figure 1 is a perspective view of an exemplary fluid processing apparatus.

[0012] Figure 2 is a schematic diagram of an exemplary disposable fluid flow circuit that may be installed in the fluid processing apparatus of Figure 1 to complete a fluid processing system according to one aspect of the present disclosure.

[0013] Figure 3 is a plan view of an exemplary cassette of the fluid flow circuit shown in Figure 2, which can be operated in conjunction with the fluid processing apparatus shown in Figure 1 to perform various different fluid processing procedures.

[0014] Figure 4 is a schematic diagram of the fluid flow circuit shown in Figure 2, installed in the fluid processing device shown in Figure 1, illustrating how the system performs the fluid processing procedure. [Modes for carrying out the invention]

[0015] A more detailed description of the systems and methods relating to this disclosure is provided below. It should be understood that the descriptions of specific apparatuses and methods below are illustrative and do not encompass all possible variations or applications.

[0016] Figures 1-4 show components of a fluid processing system embodying various aspects of the subject matter. While this specification describes the use of a system for separating blood into two or more components and collecting at least one component, it should be understood that the system described herein can be used to process a variety of fluids, which may include bodily fluids and non-bodily fluids.

[0017] In one embodiment, the system includes two main components: a durable and reusable fluid processing apparatus 10 (Figure 1) and a disposable fluid flow circuit 12 (Figure 2). The illustrated fluid processing apparatus 10 includes a rotating membrane separator drive unit 14, a centrifuge or centrifuge 16, additional components for controlling the fluid flow through the disposable flow circuit 12, and a control unit 18 that coordinates the operation of the other components of the fluid processing apparatus 10 to perform the fluid processing procedure. The type of fluid processing apparatus 10 shown in Figure 1 is described in more detail in PCT Patent Application Publication WO2018 / 053217A1, which is incorporated herein by reference. The principles described herein may be applied when using the fluid processing apparatus 10 of Figure 1, but it should be understood that the same principles may be applied to other fluid processing apparatuses, including those employing a single separation technique or approach.

[0018] I. Durable Fluid Processing Equipment The fluid processing apparatus 10 (Figure 1) is configured to be durable enough for long-term use. The fluid processing apparatus 10 in Figure 1 is merely one example of a possible configuration, and it should be understood that the fluid processing apparatus according to this disclosure may have a different configuration.

[0019] In the illustrated embodiment, the fluid 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 for improved visibility and ergonomics) and a generally vertical portion 24. The rotary membrane separator drive unit 14 and the centrifuge 16 are shown to be incorporated into the generally horizontal portion 22 of the case 20, while the control unit 18 is shown to be incorporated into the generally vertical portion 24.

[0020] A Rotating Membrane Separator Drive Unit The fluid processing apparatus 10 includes a spinner support or 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 (incorporated herein by reference) describes an exemplary rotating membrane separator drive unit suitable for incorporation into the fluid 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.

[0021] 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 located directly above the base 28, 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 rotary membrane separator drive unit 14 to orient the rotary membrane separator 26 vertically, it is also within the scope of this disclosure that the rotary membrane separator 26 may be positioned in a different orientation when mounted to the fluid processing apparatus 10.

[0022] 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 the rotary membrane separator drive unit 14 to accommodate rotary membrane separators 26 of different sizes. For example, the upper cap 30 can be moved perpendicularly to the base 28 and locked in a plurality of different positions, each locking position corresponding to a rotary membrane separator 26 of a different size.

[0023] 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 components of the rotating membrane separator 26 to be rotated include at least one element (e.g., a metallic material) configured to be acted upon by a magnet, 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.

[0024] 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 (or components rotating at different speeds) of the rotating membrane separator 26. 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.

[0025] B Centrifuge The centrifuge 16 includes a centrifugation section 32 that receives the centrifugation chamber 36 of the fluid flow circuit 12, as well as other components of the centrifuge 16. Further details regarding the exemplary configuration and operation of the centrifuge are described in PCT Patent Application Publication No. WO2018 / 053217A1.

[0026] A fluid (e.g., anticoagulated whole blood) is introduced into the centrifugation chamber 36 by the ambilicus and, as a result of the centrifugal force associated with rotation, is separated within the centrifugation chamber 36 into a layer of low-density components (e.g., platelet-rich plasma when separating blood) and a layer of high-density components (e.g., concentrated red blood cells). Components of the interface monitoring system can be arranged within the centrifugation section 32 to monitor the separation of the fluid within the centrifugation chamber 36. The interface monitoring system can include a light source 50 and a photodetector 52 positioned and oriented to receive at least a portion of the light emitted from the light source 50.

[0027] The orientation of each component of the interface monitoring system depends at least in part on the particular configuration of the centrifugation chamber 36. Generally, however, the light source 50 emits a light beam (e.g., a laser light beam) through the separated fluid components within the centrifugation chamber 36 (the centrifugation chamber 36 can be formed of a material that is substantially transmissive without absorbing light or at least light of a particular wavelength). A portion of the light reaches the photodetector 52, and the photodetector 52 transmits a signal indicating the position of the interface between the separated fluid components to the control unit 18. If the control unit 18 determines that the interface is in an incorrect position (which can 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 change the operation of the appropriate components of the fluid processing apparatus 10 to move the interface to an appropriate position.

[0028] C Other components of the fluid processing apparatus In addition to the rotary membrane separator drive unit 14 and the centrifuge 16, the fluid processing apparatus 10 can include other components that are compactly arranged to assist with fluid processing.

[0029] A generally horizontal portion 22 of the case 20 of the illustrated fluid processing apparatus 10 includes a cassette station 54, which houses a flow control cassette 48 of the fluid flow circuit 12. An exemplary flow control cassette 48 (described in more detail later) is shown in Figure 3. In one embodiment, the cassette station 54 is configured similarly to the pneumatically operated pump and valve station described in U.S. Patent Application Publication No. 2006 / 0161092. The illustrated cassette station 54 includes a plurality of clamps or valves V1-V9 (Figure 1) which move to a plurality of 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 C1-C9 of the flow control cassette 48 (Figure 3) of the fluid flow circuit 12. Depending on the configuration of the fluid flow circuit 12, the cassette 48 may not have valve stations C1 to C9 corresponding to each valve V1 to V9 of the cassette station 54. In that case, only some, not all, of the valves V1 to V9 will be used in the fluid processing procedure.

[0030] In the operating position, valves V1-V9 engage with their corresponding valve stations C1-C9, blocking fluid flow through those stations (for example, by closing one or more ports associated with valve stations C1-C9, thereby blocking fluid flow through those ports). In the retracted position, valves V1-V9 are separated from their corresponding valve stations C1-C9 (or are in contact with them with less force than in the operating position), thus allowing fluid flow through those stations (for example, by opening one or more ports associated with valve stations C1-C9, thereby allowing fluid flow through those ports). Additional clamps or valves V10 and V11 are located outside the cassette station 54 and interact with portions of the fluid flow circuit 12 at valve stations C10 and C11 (which may be the length of a pipe) to selectively allow or block fluid flow through them. The valves V1 to V9 of the cassette station 54 and the cassette 48, and the corresponding valve stations C1 to C9, may have different configurations and operations from valves V10 and V11, which are located away from the cassette station 54, and valve stations C10 and C11.

[0031] The cassette station 54 may be equipped with additional components, such as pressure sensors A1-A4. These interact with the sensor stations S1-S4 of the cassette 48 to monitor the 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. The other pressure sensors A1-A4 monitor the pressure in the rotating membrane separator 26 and the centrifuge 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 inform the operator of the state and / or attempt to return the pressure to an acceptable range without operator intervention.

[0032] The fluid processing device 10 may include a plurality of pumps P1 to P6 (collectively referred to as a pump assembly or pump system) to move fluid through the fluid flow circuit 12. Pumps P1 to P6 may have different configurations from each other, or they may be similarly configured, and they may perform similar or different functions from each other. In the illustrated embodiment, pumps P1 to P6 are configured as pneumatic pumps, which may be configured as generally described in U.S. Patent Application Publication No. 2006 / 0161092. The actuators of each pump P1 to P6 are controlled by a control unit 18 to alternately apply positive and negative pressure to the flexible membranes or diaphragms 64 of different pump chambers T1 to T6 defined by a flow control cassette 48 (Figure 4), thereby moving fluid through a portion of the fluid flow circuit 12. The configuration and operation of the pump system and the control unit 18 will be described in more detail later.

[0033] The illustrated fluid processing apparatus 10 also includes a spinner inlet sensor M1 for determining one or more characteristics of the fluid flowing into the rotating membrane separator 26, which is mounted in the 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 receives signals from the spinner inlet sensor M1 indicating one or more characteristics of the fluid flowing into the rotating membrane separator 26 and may use these signals to optimize the fluid processing procedure based on those characteristics. If the characteristics are outside the acceptable range, the control unit 18 may initiate an alarm or error condition to inform the operator of the situation. Appropriate apparatus and methods for monitoring hematocrit and / or platelet concentration are described in U.S. Patent No. 6,419,822 (incorporated herein by reference), but it should be understood that different methods may be employed to monitor one or more characteristics of the fluid or fluid components flowing into the rotating membrane separator 26.

[0034] The illustrated fluid processing apparatus 10 further includes a spinner outlet sensor M2 that houses a tube of a fluid flow circuit 12 for discharging fluid components separated from the rotating membrane separator 26. The spinner outlet sensor M2 monitors the separated fluid components and determines one or more of their characteristics, which may be done by optically monitoring the separated fluid components flowing through the tube or by other suitable means. In one embodiment, if separated plasma flows through the tube, 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 lipidemia. This may be done by using an optical monitor of the type described in U.S. Patent No. 8,556,793 (embodied herein by reference) that measures the optical density of the fluid in the relevant tube, or by other suitable apparatus and / or method.

[0035] The illustrated fluid processing apparatus further 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 a human (e.g., the same person 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 whether or not air is present 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 inform the operator of the situation and / or take corrective action to prevent air from reaching the recipient (e.g., reverse the fluid flow in the tube or divert the flow to a vent location).

[0036] The generally vertical portion 24 of Case 20 may include a plurality of volumetric measuring systems W1-W6 (six are shown, but there may be more or fewer). These are configured to be associated with one or more fluid containers F1-F7 (Figures 2 and 4) of the fluid flow circuit 12. Each volumetric measuring system W1-W6 operates in conjunction with the 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 be configured in various ways without departing the scope of this disclosure, and two or more volumetric measuring systems W1-W6 may have different configurations. As an example, a volumetric measuring system W1-W6 may be configured as, or to include, a weight scale configured to support and measure the weight of the fluid in the associated fluid containers F1-F7 (the measured weight is converted to volume by a component of the volumetric measuring system W1-W6 or by the control unit 18). As another example, volumetric measurement systems W1-W6 may include one or more sensors configured to detect the volume and / or volume change of fluid in associated fluid containers F1-F7. Volumetric measurement systems including additional components (e.g., both weight scales and sensors) and / or alternative components can also be employed without departing from the scope of this disclosure.

[0037] Regardless of its specific configuration, each volume measurement system W1-W6 may transmit a signal to the control unit 18 indicating the fluid volume 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 fluid processing volume and flow rate, and, based on the derived processing volume, generate signals to control processing events, at least in part. For example, the control unit 18 can diagnose leaks or blockages in the fluid flow circuit 12 and notify the operator.

[0038] The illustrated case 20 is also provided with a number of hooks or supports H1 and H2, which can support various components of the fluid flow circuit 12 or other articles of appropriate size and shape.

[0039] D Control Unit According to one aspect of the present disclosure, the fluid processing apparatus 10 includes a control unit 18 which is appropriately configured or programmed to control the operation of the fluid processing apparatus 10. In one embodiment, the control unit 18 includes a main processing unit (MPU), which may include, for example, an Intel Pentium™ type microprocessor, but other types of conventional microprocessors may also be used. In one embodiment, the control unit 18 may be mounted in a generally vertical portion 24 of the case 20, 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 fluid processing apparatus 10 (physically, by cables, etc., or wirelessly).

[0040] The control unit 18 is configured and / or programmed to perform at least one fluid processing procedure, but more advantageously, it is configured and / or programmed to perform a variety of different fluid processing procedures. For example, the control unit 18 may be configured 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.

[0041] More specifically, in carrying out these fluid processing procedures, the control unit 18 is configured or programmed to control one or more of the following tasks: taking fluid into a fluid flow circuit 12 attached to the fluid processing apparatus 10; transporting the fluid to a separation location (i.e., a rotating membrane separator 26 or centrifugal separator 36 in the fluid flow circuit 12); separating the fluid into two or more components as desired; and transporting the separated components to a storage container, a second location for further separation (e.g., to either a rotating membrane separator 26 or centrifugal separator 36 not used in the initial separation stage), or to a recipient (which may be the source from which the fluid was originally taken).

[0042] 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 apply a specific (positive or negative) pressure to the flexible membranes or diaphragms 64 of the associated pump chambers T1-T6 of the cassette 48 for a specific period of time, so that fluid passes through a portion of the fluid flow circuit 12 at a specific flow rate. Therefore, even if it is stated herein that a specific component of the fluid processing apparatus 10 (e.g., the rotating membrane separator drive unit 14 or the centrifuge 16) performs a specific function, it should be understood that the component is controlled by the control unit 18 to perform that function.

[0043] Before, during, and after the procedure, the control unit 18 can receive signals from various components of the fluid processing device 10 (e.g., pressure sensors A1-A4) and monitor various aspects of the operation of the fluid 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 the components and / or one or more characteristics of the fluid or separated fluid components are outside the acceptable range, the control unit 18 can activate an alarm or error condition to inform the operator of the condition and / or take measures to correct the condition. Appropriate corrective measures may depend on the specific error condition and may be performed with or without operator involvement.

[0044] For example, the control unit 18 may include an interface control module, which 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 instruct the appropriate components of the fluid processing apparatus 10 to change their operation in order to move the interface to the correct position. For example, the control unit 18 can 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 at a different speed using the centrifuge 16.

[0045] If an operator interface station is provided associated with the control unit 18, the operator can view information about the system's operation on a screen or display (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. Otherwise, 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. Within the scope of this disclosure, the operator interface station may be configured to receive input from both a touchscreen and a separate input device (e.g., a keypad).

[0046] II. Disposable Fluid Flow Circuits The fluid flow circuit or flow set 12 (Figure 2) is sterile and intended as a single-use disposable item. Before initiating a predetermined fluid handling procedure, the operator attaches the various components of the fluid flow circuit 12 to the case 20 in association with the fluid 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 disconnects the fluid flow circuit 12 from its association with the fluid processing device 10. The portion of the fluid flow circuit 12 holding 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 fluid flow circuit 12 is removed from the case 20 and discarded.

[0047] In the illustrated embodiment, the fluid flow circuit 12 includes a cassette 48 (Figure 3), and other components of the fluid flow circuit 12 are connected to this cassette 48 by flexible tubes. 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. The illustrated flow circuit 12 further 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.

[0048] The flow control cassette 48 provides a centralized, programmable, and integrated platform for all the pumping and numerous valve functions required for a given fluid processing procedure. In one embodiment, the cassette 48 is configured similarly to the cassette in U.S. Patent Publication 2006 / 0161092, but is adapted to include various stations and flow paths necessary to perform the fluid processing procedure carried out by the fluid processing system.

[0049] During use, the cassette 48 is attached to the cassette station 54 of the fluid processing apparatus 10, and positioned so that the flexible membrane or diaphragm 64 of the cassette 48 is in contact with the cassette station 54. The flexible diaphragm 64 covers an array of internal cavities formed by the body of the cassette 48. These different internal cavities define sensor stations S1-S4, valve stations C1-C9, pump stations T1-T6, and multiple flow paths. The side of the cassette 48 opposite to the flexible diaphragm 64 may be sealed by another flexible diaphragm or rigid cover, thereby isolating the fluid flow through the cassette 48 from the external environment.

[0050] Each sensor station S1-S4 is aligned with a corresponding pressure sensor A1-A4 in the cassette station 54, and each pressure sensor A1-A4 can monitor the pressure within the corresponding sensor station S1-S4. Each valve station C1-C9 is aligned with a corresponding valve V1-V9, and may define one or more ports that enable fluid communication between the valve stations C1-C9 and other internal cavities (e.g., flow paths) in the cassette 48. As described above, each valve V1-V9 moves 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 to selectively contact the valve stations C1-C9 in the cassette 48. In the activated position, the valves V1-V9 engage with the corresponding valve stations C1-C9, closing one or more of their ports to prevent fluid from passing through. In the retracted position, valves V1-V9 are separated from their corresponding valve stations C1-C9 (or are in contact with them with less force than in the operating position), so that one or more ports associated with valve stations C1-C9 are opened, allowing fluid to pass through.

[0051] As described above, the cassette 48 defines multiple pump chambers T1 to T6, each pump chamber interacting with a pneumatic pump P1 to P6 located in the cassette station 54 of the fluid processing device 10. Different pumps P1 to P6 may interact with the pump stations T1 to T6 of the cassette 48 during a procedure to perform different tasks, but in the context of this disclosure, each of the pumps P1 to 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.

[0052] Tubes of various lengths extend from the sides of the cassette 48 and are connected to other components of the fluid flow circuit 12, such as various fluid containers F1-F7, the rotating membrane separator 26, and the centrifugal chamber 36. The tubes connected to the centrifugal chamber 36 (including one inlet tube and two outlet tubes) can be assembled as an umbilicus.

[0053] Various additional components may be incorporated into the tubes extending from the cassette 48, or into one of the cavities of the cassette 48. For example, as shown in Figure 2, 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 located on the line upstream of the centrifugal chamber 36.

[0054] III. Example of a Fluid Processing Procedure An example of a fluid processing procedure according to this disclosure is described below. In this example, blood is separated into concentrated red blood cells and platelet-concentrated plasma (PRP) by centrifugation. A portion of the platelet-concentrated plasma is recirculated through a centrifugation chamber, and another portion is separated into platelet concentrate and platelet-poor plasma, and this process is repeated until a predetermined volume of platelets is collected. The procedure described below is merely an example, and it should be understood that the principles described herein can be combined with other fluid processing procedures (for example, a procedure for recirculating platelet-poor plasma into a centrifugation chamber during blood separation) without departing from the scope of this disclosure.

[0055] Prior to processing, the operator selects a desired protocol (for example, using an operator interface station if one is provided). This informs the control unit 18 how it should control other components of the fluid processing apparatus 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 and 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, such as a pre-count of platelets.

[0056] If there are fluid containers (e.g., platelet additive containers) that are not integrally formed with the fluid flow circuit 12, they can be connected to the fluid flow circuit 12 (e.g., by puncturing the tubular partitions of the fluid flow circuit 12, or via Luer connectors). The fluid flow circuit 12 is then attached to the fluid processing apparatus 10 (which, as appropriate, includes associating the fluid containers F1-F7 with volume measurement systems W1-W6). As an example, each volume measurement system W1-W6 includes a weight scale associated with a hook for suspending the fluid container. As another example, at least one of the volume measurement systems W1-W6 includes a weight scale associated with a horizontal platform or surface, the container is placed and supported on that platform or surface, and the weight scale transmits a signal to the control unit 18 indicating the weight of the container (and its contents) throughout the course of the procedure. In other embodiments, the fluid container may be associated with a volume measurement system that omits the weight scale, but even in that case, other means (e.g., one or more sensors) for measuring the volume of fluid in the container are included.

[0057] The control unit 18 may perform a consistency check of the fluid flow circuit 12 to confirm that each component is properly connected and functioning correctly. If the consistency check is successful, the fluid supply 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 delivering saline solution from a saline container F2 by operating one or more pumps P1 to P6 of the fluid processing device 10).

[0058] After the fluid flow circuit 12 is primed, fluid processing can be initiated. In the first stage of an exemplary platelet collection procedure (Figure 4), 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 through a single needle connected to the cassette by line L1. Line L1 is provided with a manual clamp 56, which may initially be in a closed position, preventing fluid flow through line L1. When processing is initiated, the operator moves the manual clamp 56 from the closed position to the open position, allowing fluid flow through line L1.

[0059] Blood is drawn into line L1 by the supply pump P2 of the fluid processing device 10. The anticoagulant from the anticoagulant container F1 is drawn through line L2 by the operation of the anticoagulant pump P1 and can be added to the blood at the junction of lines L1 and L2.

[0060] In the illustrated embodiment, valve V10 is open, allowing anticoagulated blood to pass through line L3 and the sensor station of the cassette associated with pressure sensor A1. Valve V11, on the other hand, is closed, preventing fluid flow through line L4. If the blood source is a living organism (e.g., a donor), pressure sensor A1 can communicate with the control unit 18 to monitor the pressure in the vein of the blood source.

[0061] 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 directed to the processing container F3 via line L7 and the cassette's sensor station associated with pressure sensor A3, while the remainder goes to the centrifugal pump P3 via line L8. The centrifugal pump P3 controls the amount of blood sent to the centrifuge chamber 36 rather than the processing container F3. Specifically, the flow rate of the source pump P2 is greater than that 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 stage.

[0062] Blood, delivered by the centrifugal pump P3 through line L8, passes through line L9, air trap 62, and a sensor station on a cassette associated with pressure sensor A2 (this pressure sensor A2 works in conjunction with the control unit 18 of the fluid processing device 10 to monitor the pressure in the centrifugal chamber 36) before reaching the centrifugal chamber 36 of the fluid flow circuit 12. The centrifuge 16 of the fluid processing device 10 operates the centrifugal chamber 36 to separate the blood in the centrifugal chamber 36 into platelet-concentrated plasma and concentrated red blood cells. In one embodiment, the centrifugal chamber 36 is nominally rotated at 4500 rpm, but the specific rotation speed may vary depending on the flow rates of inflow and outflow into the centrifugal chamber 36.

[0063] Red blood cells are discharged from the centrifuge chamber 36 via line L10 and flow into the blood return container F4 via line L11. Platelet-concentrated plasma is drawn from the centrifuge chamber 36 via line L12 by the cooperative action of the recirculation pump P5 and outlet pump P4 of the fluid processing device 10. The platelet-concentrated plasma flows through line L12 and, upon reaching a branching point, splits into lines L13 and L14. The recirculation pump P5 is associated with line L13 and recirculates a portion of the platelet-concentrated plasma, returning it to a confluence point for mixing with the blood being transported to the centrifuge chamber 36 by the centrifugal pump P3 in line L8. By recirculating a portion of the platelet-concentrated plasma along with the incoming blood to the centrifuge chamber 36, the hematocrit of the blood flowing into the centrifuge chamber 36 is reduced, potentially improving separation efficiency. With this configuration, the flow rate of the fluid flowing into the centrifuge 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 into 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.

[0064] Line L14 terminates at a branching point where it merges with lines L15 and L16. Valve V6 is closed, preventing fluid flow through line L16 and guiding the separated platelet-concentrated plasma through line L15 to the rotating membrane separator 26. 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, while pressure sensor A4 can monitor the pressure in the rotating membrane separator 26.

[0065] In Figure 4, valve V6 is shown in a closed state, but it 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. One example of this is at the start of the procedure, when the separation has been initialized and platelets have not yet been discharged from the centrifuge chamber 36. In this case, the fluid being transported through line L14 by the outlet pump P4 can be diverted to the blood return container F4.

[0066] The rotating membrane separator drive unit 14 of the fluid processing apparatus 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 fluid processing apparatus 10. Valves V5, V6, V8, and V9 are closed, and the separated plasma is guided along line L18, through valve V4, to the blood return container F4 (along with the separated red blood cells). On its way to the blood return container F4, the plasma passes through the spinner outlet sensor M2. This sensor M2 works in cooperation with the control unit 18 to determine one or more characteristics of the plasma, such as the amount of cellular blood components in the plasma, and / or whether the plasma is hemolytic and / or lipidemia.

[0067] 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 can be selectively opened to allow fluid flow through line L20, which can then be merged at a branching point with plasma heading towards the blood return container F4 via line L18.

[0068] Depending on the volume of platelets to be collected, the blood collection stage in Figure 4 may be repeated. The blood collection stage alternates with a blood return stage in which the blood in the processing container F3 is separated in the centrifuge chamber 36, while the already collected blood components in the return container F4 are returned to the blood source. During such a blood return stage, the separated red blood cells and platelet-concentrated plasma pass through various pathways in the fluid flow circuit 12, and, as in the blood collection stage in Figure 4, after being separated from platelet-poor plasma in the rotating membrane separator 26, an additional volume of platelets is collected in the platelet collection container F6. Before ending the procedure, a platelet additive from the additive container F7 may be added to the collected platelets in the platelet collection container F6.

[0069] IV Notification System As described herein, the control unit 18 can receive signals from various components of the fluid processing apparatus 10 and monitor various operating surfaces of the fluid processing apparatus 10, as well as the characteristics of the fluid flowing through the fluid flow circuit 12 and the separated fluid components. If there is a malfunction in the operation of any component, if an error condition exists (for example, if air is present in a pipe, or after a leak or blockage in the fluid flow circuit 12 is detected), and / or if one or more characteristics of the fluid or separated fluid components (e.g., fluid pressure, hematocrit, platelet concentration, and / or volume) are outside an acceptable hardcoded range or value, the control unit can provide an alert and / or notification to the operator. In one embodiment, the alert may be an audible alert. For example, an audible alert may be a chime, alarm, ding, voice recording, or other appropriate audible alert. The apparatus 10 may include a speaker for providing audible alerts. In some embodiments, the alert may be a visual alert. For example, the control unit 18 can instruct the device 10 to illuminate a status light, display a visual alert such as an alphanumeric message on the operator interface (if any), or display other appropriate visual alerts. As an example, the device 10 may be associated with an external device via a wireless or wired connection, and the control unit 18 may be configured to provide alerts and / or notifications through that external device. The external device may be, but not limited to, a panel configured to monitor all operational equipment in the system (including the device 10). The external device may include speakers, lights, and / or screens. Alerts may be audible and / or visual alerts. For example, the device 10 may be configured to provide real-time information through a data management system such as a Fresenius DXT system. Real-time information from the device 10 may be remotely monitored by the external device.

[0070] In addition to being configured to provide alerts and / or notifications based on hardcoded values, the control unit 18 is configured to provide "intelligent" alerts and / or notifications based on events monitored during blood processing procedures. For example, instead of only alerting the operator when a specific value is detected, the control unit 18 can provide alerts and / or notifications in response to dynamic events during the procedure, resulting in a more personalized and efficient procedure.

[0071] Similar to providing alerts based on hardcoded values, the control unit 18 is configured to provide "intelligent" alerts and / or notifications using the various sensors of the device 10. The control unit 18 may be configured to receive information from the system's sensors, store and analyze that information to determine when and how to provide alerts and / or notifications. Furthermore, the control unit 18 may be configured to record the operation and behavior of the device 10 and use this information to determine when and how to provide alerts and / or notifications. In some embodiments, the control unit 18 includes an onboard procedure estimator. The onboard procedure estimator may be configured to determine procedure results based on system settings. For example, the onboard procedure estimator may determine procedure results based on parameters entered by the operator before the procedure started, adjustments made by the control unit 18 during the procedure, and / or adjustments made by the operator during the procedure. For example, the onboard procedure estimator can determine procedure outcomes by considering factors such as air detection / purging, centrifugal line occlusion requiring saline to clear line blockages, procedure efficiency due to flow rate (which may be adjusted by the control unit 18 or the operator), or operator-initiated events such as saline injection during the procedure (e.g., to respond to the citrate reaction or to prevent blood coagulation during prolonged pauses / stops). Furthermore, the control unit 18 may include an optimizer. The optimizer may be configured to determine the optimal procedure configuration and objectives using the output of the onboard estimator and inputs not used by the estimator (e.g., blood type and / or donor / donation history).

[0072] For example, monitored events may include the optimal point in time when parameters can be changed during the procedure. In some embodiments, the operator may manually adjust procedure parameters during the procedure. The control unit 18 may be configured to determine the safe and / or optimal timing for adjusting parameters during the procedure. By utilizing the onboard procedure estimator of the control unit 18 and information from various sensors of the device 10, it is possible to predict the impact of changes to the procedure on other appropriate procedure inputs, such as target dose (i.e., changing from a dual platelet dose to a triple platelet dose, or simultaneous plasma product collection), target product volume / quantity, donor parameters (i.e., pre-count), or procedure settings (i.e., CIR rate). Optimal timing is any point in the procedure except during times when parameter changes are not recommended (e.g., before and after), and such times are considered suboptimal. Suboptimal timing is any point in the procedure where a parameter change may be deemed unsafe for the patient / donor. In some embodiments, the control unit 18 may notify the operator a certain time before a point in the procedure where a parameter change would become unsafe for the donor / patient. For example, the control unit 18 may be configured to issue an alert to the operator 5 minutes, 10 minutes, or at any other appropriate time before parameter adjustment becomes unsafe.

[0073] In some embodiments, the control unit 18 may be optionally configured to lock a parameter (i.e., prevent parameter adjustment) if there is no optimal time to change the parameter during the procedure. For example, the control unit 18 may be configured to lock a parameter if the optimal time to change that parameter has already passed during the procedure. For instance, if the optimal time to adjust a parameter to terminate the procedure early has passed, the operator cannot change that parameter to terminate the procedure early. Furthermore, in some embodiments, the operator (or administrator or supervisor) can select which parameters to lock after the optimal time to adjust them has passed. For example, before the procedure begins, the operator can select a setting via a user interface (if any), and the control unit 18 can be configured to lock that parameter after the optimal time to change it has passed. By configuring the control unit 18 to lock parameters after the optimal time for adjusting each parameter has passed, the operator does not need to determine whether changing a parameter at a particular time is safe for the patient, thus reducing the operator's cognitive load.

[0074] In some embodiments, the events monitored may include the amount of time remaining in a blood processing procedure. For example, the control unit 18 may be configured to provide alerts and / or notifications indicating the amount of time remaining in a procedure being performed by the device 10. The amount of time remaining may be consistent across procedures performed by the device 10. For example, the control unit 18 may be configured to provide alerts and / or notifications indicating that the time remaining in a procedure is 5 minutes, 10 minutes, or other appropriate amount of time.

[0075] Typically, the device can provide alerts based on volume to indicate that a procedure is nearing completion, but this can result in inconsistent timing of alerts due to fluctuations in flow rate between procedures. By configuring the control unit 18 to monitor the procedure, it can analyze information from various sensors in the device 10 (e.g., flow rate) and provide alerts and / or notifications based on the amount of time remaining in the procedure. In this way, the control unit 18 can provide alerts to the operator at a consistent time when the amount of time remaining in the procedure is constant, regardless of the type of procedure, allowing the operator to have a certain amount of time to prepare post-procedure supplies as needed. For example, the operator can be prompted to gather supplies needed for donor / patient separation / post-processing or to begin post-procedure vital sign measurements of the donor / patient. Receiving alerts at consistent timing at the end of the procedure allows the operator to rotate donors / patients more efficiently, and as a result, the blood donation center / treatment center can accept more donors / patients.

[0076] Furthermore, in some embodiments, the monitored events may include the remaining procedure time until the solution container associated with the disposable circuit 12 is empty. Specifically, the control unit 18 may be configured to provide alerts and / or notifications when there is a certain remaining time until the solution container (e.g., F1, F2, and / or F7) associated with the disposable circuit 12 is empty. In some examples, one or more solution containers may contain any appropriate solution, such as additives (e.g., PAS), saline solution, or anticoagulants (e.g., the anticoagulant dextrose citrate (ACD)). Furthermore, one or more solution containers may be monitored using volume measurement systems W1-W6. As described herein, the control unit 18 may be configured to monitor the rate of procedure progress. Using the rate of procedure progress and information from the volume measurement systems W1-W6, the onboard procedure estimator of the control unit 18 can determine whether a particular solution container contains enough solution to complete the remainder of the procedure. The control unit 18 may be configured to provide alerts and / or notifications at consistent timings when the remaining time until a container is empty is 5 minutes, 10 minutes, or other appropriate time. By providing alerts at regular intervals based on the remaining time until the solution container is empty, the operator is notified to check the solution in the container and prepare an additional container to replace the nearly empty container. The operator can then replace the container (after configuring the system safely for container replacement), minimizing downtime and improving the efficiency of the procedure. For example, the control unit 18 may be configured to notify the operator when a collection container containing PAS or saline (used for reinjection / post-collection processing) is nearing empty, or whether the amount of anticoagulant solution (e.g., ACD) is sufficient to complete the procedure.

[0077] Furthermore, in some embodiments, the control unit 18 may be configured to provide alerts and / or notifications when a specific amount of time is remaining at a particular step of the blood processing procedure. For example, the control unit 18 may be configured to monitor the processing rate of each step of the blood processing procedure. Based on the monitored rate, the control unit 18 can determine the amount of time remaining at that step. The control unit 18 can then provide alerts and / or notifications when a specific amount of time is remaining at a step of the procedure. For example, the control unit 18 can provide alerts and / or notifications when there is 5 minutes, 10 minutes, or other appropriate remaining time at a step. The control unit 18 may be configured to provide alerts and / or notifications at various steps of the blood processing procedure, such as whole blood collection, separation of whole blood into hematologic products, collection of the separated hematologic products, and / or other appropriate steps in the blood processing procedure.

[0078] Furthermore, in some embodiments, the control unit 18 may be configured to provide alerts and / or notifications after a certain period of time has elapsed since the start of the procedure, or at predetermined time intervals during the procedure. In some embodiments, the operator (or administrator or supervisor) can select the time or time interval at which the alerts and / or notifications are provided and configure the control unit accordingly. For example, the operator (or administrator or supervisor) may configure the control unit 18 to provide alerts and / or notifications after a certain period of time to check on the donor / patient's condition. This may be done to remind the operator to assess the donor / patient's condition, for example, after the donor / patient has complained of feeling cold or uncomfortable, or after a mild citrate reaction.

[0079] Furthermore, in some embodiments, the control unit 18 may be configured to provide alerts and / or notifications after a specific event in a procedure, or if a specific event does not occur during the procedure. For example, the control unit 18 may provide an alert and / or notification if the operator has not entered an updated donor parameter from a pre-sample that should be entered into the system (i.e., the control unit 18) by a predetermined time. The control unit 18 may provide alerts and / or notifications after any appropriate event in a procedure. In some examples, the operator (or administrator or supervisor) may pre-select the events that trigger the control unit 18 to provide alerts and / or notifications.

[0080] In some embodiments, monitored events may include the blood processing procedure approaching a selected target product volume. For example, the control unit 18 may be configured to provide an alert and / or notification to the operator when the target blood product approaches a pre-selected / set target volume. For example, the control unit 18 may provide this alert and / or notification based on the amount / volume of target blood product collected or the amount of time remaining in the procedure. In a specific example, the control unit 18 may be configured to provide an alert and / or notification based on the amount / volume of target blood product collected, as determined by the onboard estimator using factors such as the volume processed or the time remaining in the procedure. The target blood product is not limited to platelet volume, plasma volume, red blood cell volume, and other appropriate blood products. After an alert and / or notification is provided that the procedure is approaching a target product volume, the operator can use information from the onboard procedure estimator and optimizer to suggest a more optimal procedure to the donor (if a more optimal procedure is possible) or to confirm whether the donor is willing to stay longer. For example, this could include collecting additional blood products or making procedural adjustments such as changing procedural parameters (e.g., flow rate). This could increase the overall amount of products collected and allow for the collection of products that are of greater value to the blood donation center / treatment center.

[0081] In some embodiments, monitored events may include adjustments to predetermined parameters in a blood processing procedure. As described herein, the control unit 18 is configured to cause the device 10 to perform a blood processing procedure. For example, the control unit 18 is configured to instruct the device to open valves, operate pumps to affect the fluid flow through the disposable circuit 12, or operate the separation chamber. Before initiating a blood processing procedure, the operator (or administrator or supervisor) may input predetermined parameters to the control unit 18, and / or the control unit may pre-set parameters based on a selected procedure. For example, predetermined parameters may include, but are not limited to, a target product volume, flow rate, pressure, procedure time, target volume of whole blood to be processed, spinner speed, anticoagulant ratio, citrate injection rate, and cuff pressure. During the procedure, the control unit 18 may be configured to instruct the device 10 to act in response to information or error conditions received from one or more sensors. In some cases, such action may involve adjusting one or more predetermined parameters to continue the procedure. The control unit 18 is configured to provide alerts and / or notifications when one or more predetermined parameters are adjusted. By notifying the operator that the predetermined parameters have been adjusted, the operator can confirm whether the action was necessary or override the action.

[0082] For example, the control unit 18 may be configured to detect a venous occlusion event and, in response, increase the cuff pressure and / or decrease the sampling rate of the procedure. In this case, the control unit 18 is configured to provide an alert and / or notification after the response action. This informs the operator that the control unit 18 has instructed the device 10 to act in order to maintain good flow. By providing an alert and / or notification, the operator can prompt the donor to squeeze or override that action if the venous occlusion was not a recurring issue (i.e., the donor simply moved their arm).

[0083] As another example, the control unit 18 may provide alerts and / or notifications to the operator when adjustments are made to the procedure time and / or the amount / volume of fluid to be processed (e.g., whole blood). For example, the procedure time may be extended or shortened. As described herein, in some cases the operator may manually adjust certain parameters during the procedure. For example, the operator may change donor parameters such as pre-counts and red blood cell content, procedure targets, or settings within the procedure (i.e., AC ratio / citrate infusion rate). Furthermore, the control unit 18 may instruct the apparatus 10 to perform actions such as adjusting certain parameters to complete the procedure. In these cases, even if the procedure time and the volume of fluid to be processed are not directly adjusted, adjustments to other parameters or settings may result in the control unit 18 indirectly adjusting the procedure time and / or the volume of fluid to be processed. Therefore, the control unit 18 is configured to provide alerts and / or notifications to the operator that the procedure time has been shortened or extended and / or that the volume of fluid to be processed (e.g., whole blood) has increased or decreased.

[0084] In some embodiments, the events monitored may include device performance events. In this case, the control unit 18 is configured to provide alerts and / or notifications to the operator when the device 10 detects a procedural problem, such as an error condition as described herein. For example, the device 10 may use its various sensors to detect venous occlusion, poor interface control (i.e., spillover), the presence of lipoplasma, or other procedural problems. If lipoplasma is detected, the system may not be able to continue the collection procedure or may result in poor collection unless adjustments are made (e.g., configuration adjustments of the optical measurement system including the light source 50 and photodetector 52). In the case of a device performance event, the control unit 18 may be configured to provide alerts and / or notifications to the operator as a gentle reminder so as not to startle the donor / patient. In other words, the alerts and / or notifications may be gentler than other alerts and / or notifications described herein. For example, the alerts and / or notifications may be chimes. The operator can check the device 10 and decide whether to continue, pause, or terminate the procedure.

[0085] The apparatus and methods described herein include, but are not limited to, the following embodiments, and additional embodiments exist.

[0086] Appearance 1 A blood processing system comprising a reusable separation device, the reusable separation device including a separator, and a disposable fluid circuit, the disposable fluid circuit including a separation chamber and a plurality of containers, and configured to be associated with the reusable separation device, wherein the reusable separation device includes a control unit configured to monitor a blood processing procedure and to provide one or more notifications based on events monitored during the blood processing procedure.

[0087] Appearance 2 The system according to Embodiment 1, wherein the one or more of the aforementioned notifications are audible or visual notifications.

[0088] Appearance 3 The system according to Embodiment 1 or Embodiment 2, wherein the monitored event includes an optimal time in which the parameters can be changed during the procedure.

[0089] Pattern 4 The system according to embodiment 3, wherein the control unit is configured to lock the parameter after the optimal time in the procedure for changing the parameter has passed.

[0090] Appearance 5 The system according to embodiment 3 or 4, wherein the parameters include a target dose, a target product volume, donor parameters, and / or procedure settings.

[0091] Appearance 6 The system according to any one of embodiments 1 to 5, wherein the monitored event includes the amount of time remaining in the blood processing procedure.

[0092] Appearance 7 The system according to embodiment 6, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

[0093] Appearance 8 The system according to any one of embodiments 1 to 7, wherein the monitored event includes the blood processing procedure approaching a selected target product amount.

[0094] Appearance 9 The system according to any one of embodiments 1 to 8, wherein the monitored event includes the amount of time remaining in the procedure until the solution container associated with the disposable circuit is emptied.

[0095] Appearance 10 The system according to embodiment 9, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

[0096] Appearance 11 The monitored event is a system according to any one of embodiments 1 to 10, including the adjustment of predetermined parameters in the procedure.

[0097] Appearance 12 The system according to embodiment 11, wherein the adjustment includes extending or shortening a predetermined time for the procedure.

[0098] Appearance 13 The system according to embodiment 11, wherein the adjustment includes increasing or decreasing the volume of the fluid to be processed.

[0099] Appearance 14 The system described in any one of the embodiments 1 to 13, wherein the monitored events include device performance events.

[0100] Appearance 15 The system according to embodiment 14, wherein the device performance events include venous occlusion, control of the interface between separated blood components, and / or the presence of lipoplasma.

[0101] Appearance 16 The system according to any one of embodiments 1 to 15, wherein the control unit is configured to provide a notification after a predetermined period of time has elapsed.

[0102] Appearance 17 A blood processing apparatus comprising a separator and a control unit configured to monitor a blood processing procedure and provide one or more notifications based on events monitored during the blood processing procedure.

[0103] Appearance 18 The apparatus according to embodiment 17, configured to be associated with a disposable fluid circuit including a separation chamber and a plurality of containers.

[0104] Appearance 19 The apparatus according to aspect 17 or aspect 18, wherein the one or more of the notifications are audible or visual.

[0105] Appearance 20 The apparatus according to any one of embodiments 17 to 19, wherein the monitored event includes an optimal time in which the parameters can be changed during the procedure.

[0106] Appearance 21 The apparatus according to embodiment 20, wherein the control unit is configured to lock the parameter after the optimal time in the procedure for changing the parameter has passed.

[0107] Appearance 22 The apparatus according to embodiment 20 or embodiment 21, wherein the parameters include a target dose, a target product volume, donor parameters, and / or procedure settings.

[0108] Appearance 23 The apparatus according to any one of embodiments 17 to 22, wherein the monitored event includes the amount of time remaining in the blood processing procedure.

[0109] Pattern 24 The apparatus according to embodiment 23, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

[0110] Appearance 25 The apparatus according to any one of embodiments 17 to 24, wherein the monitored event includes the blood processing procedure approaching a selected target product amount.

[0111] Appearance 26 The apparatus according to any one of embodiments 18 to 25, wherein the monitored event includes the amount of time remaining in the procedure until the solution in one of the plurality of containers of the disposable fluid circuit is emptied.

[0112] Appearance 27 The apparatus according to embodiment 26, wherein the control unit is configured to determine the amount of time remaining in the blood processing procedure based on the processing speed of the blood processing procedure.

[0113] Appearance 28 The apparatus according to any one of embodiments 17 to 27, wherein the monitored event includes adjustment of predetermined parameters in the procedure.

[0114] Appearance 29 The apparatus according to embodiment 28, wherein the adjustment includes extending or shortening a predetermined time for the procedure.

[0115] Appearance 30 The apparatus according to embodiment 28, wherein the adjustment includes increasing or decreasing the volume of the fluid to be processed.

[0116] Appearance 31 The monitored events include device performance events, as described in any one of the embodiments 17 to 30 of the apparatus.

[0117] Appearance 32 The apparatus according to embodiment 31, wherein the apparatus performance events include venous occlusion, control of the interface between separated blood components, and / or the presence of lipoplasma.

[0118] Appearance 33 The apparatus according to any one of embodiments 17 to 32, wherein the control unit is configured to provide a notification after a predetermined period of time has elapsed.

[0119] It will be understood that the embodiments and examples described above are illustrative of some applications or principles of the subject matter. Those skilled in the art can make numerous modifications without departing from the spirit and scope of the claimed subject matter, including those involving combinations of features individually disclosed or claimed herein. Therefore, it will be understood that the scope of this application is not limited to the above description but is defined in the following claims, which may be directed to features including combinations of features individually disclosed or claimed herein.

Claims

1. A reusable separation device, comprising a separator, A disposable fluid circuit comprising a separation chamber and a plurality of containers, and configured to be associated with the reusable separation device, The reusable separation device includes a control unit configured to monitor a blood processing procedure and provide one or more notifications based on events monitored during the blood processing procedure, in a blood processing system.

2. The system according to claim 1, wherein the one or more notifications are audible or visual notifications.

3. The system according to claim 1 or 2, wherein the monitored event includes an optimal time in which the parameters can be changed during the procedure.

4. The system according to claim 3, wherein the control unit is configured to lock the parameter after the optimal time in the procedure for changing the parameter has passed.

5. The system according to claim 3 or 4, wherein the parameters include a target dose, a target product volume, donor parameters, and / or procedure settings.

6. The system according to any one of claims 1 to 5, wherein the monitored event includes the amount of time remaining in the blood processing procedure.

7. The system according to claim 6, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

8. The system according to any one of claims 1 to 7, wherein the monitored event includes the blood processing procedure approaching a selected target product amount.

9. The system according to any one of claims 1 to 8, wherein the monitored event includes the amount of time remaining in the procedure until the solution container associated with the disposable circuit is empty.

10. The system according to claim 9, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

11. The system according to any one of claims 1 to 10, wherein the monitored event includes adjusting predetermined parameters in the procedure.

12. The system according to claim 11, wherein the adjustment includes extending or shortening a predetermined time for the procedure.

13. The system according to claim 11, wherein the adjustment includes increasing or decreasing the volume of the fluid to be processed.

14. The system according to any one of claims 1 to 13, wherein the monitored events include device performance events.

15. The system according to claim 14, wherein the device performance events include venous occlusion, control of the interface between separated blood components, and / or the presence of lipoplasma.

16. The system according to any one of claims 1 to 15, wherein the control unit is configured to provide a notification after a predetermined period of time has elapsed.

17. Separator and, A blood processing apparatus comprising a control unit configured to monitor a blood processing procedure and provide one or more notifications based on events monitored during the blood processing procedure.

18. The apparatus according to claim 17, configured to be associated with a disposable fluid circuit including a separation chamber and a plurality of containers.

19. The apparatus according to claim 17 or 18, wherein the one or more notifications are audible or visual notifications.

20. The apparatus according to any one of claims 17 to 19, wherein the monitored event includes an optimal time in which the parameters can be changed during the procedure.

21. The apparatus according to claim 20, wherein the control unit is configured to lock the parameter after the optimal time in the procedure for changing the parameter has passed.

22. The apparatus according to claim 20 or 21, wherein the parameters include a target dose, a target product volume, donor parameters, and / or procedure settings.

23. The apparatus according to any one of claims 17 to 22, wherein the monitored event includes the amount of time remaining in the blood processing procedure.

24. The apparatus according to claim 23, wherein the control unit is configured to determine the amount of time remaining for the blood processing procedure based on the processing speed of the blood processing procedure.

25. The apparatus according to any one of claims 17 to 24, wherein the monitored event includes the blood processing procedure approaching a selected target product amount.

26. The apparatus according to any one of claims 18 to 25, wherein the monitored event includes the amount of time remaining in the procedure until the solution in one of the plurality of containers of the disposable fluid circuit is emptied.

27. The apparatus according to claim 26, wherein the control unit is configured to determine the amount of time remaining in the blood processing procedure based on the processing speed of the blood processing procedure.

28. The apparatus according to any one of claims 17 to 27, wherein the monitored event includes adjusting predetermined parameters in the procedure.

29. The apparatus according to claim 28, wherein the adjustment includes extending or shortening a predetermined time for the procedure.

30. The apparatus according to claim 28, wherein the adjustment includes increasing or decreasing the volume of the fluid to be processed.

31. The apparatus according to any one of claims 17 to 30, wherein the monitored events include apparatus performance events.

32. The apparatus according to claim 31, wherein the apparatus performance events include venous occlusion, control of the interface between separated blood components, and / or the presence of lipoplasma.

33. The apparatus according to any one of claims 17 to 32, wherein the control unit is configured to provide a notification after a predetermined period of time has elapsed.

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