Collecting fluid components

Abstract

Examples of methods for separating / collecting components from multicomponent fluids such as whole blood are described. Some embodiments provide controlling the amount of components, such as platelets, introduced into the separation chamber to ensure that the density of the fluid in the separation chamber does not exceed a specific value. This can be used to collect a purer component. Other embodiments may provide determining the chamber flow rate based on the component concentration in the multicomponent fluid, and then the chamber flow rate can be used to determine the centrifugation rate to collect a purer, concentrated component.

Description

[0001] This application is a divisional application of application number 201780071255.9, filed on October 13, 2017, entitled "Collection of Fluid Components".

[0002] Cross-reference to related applications

[0003] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 407,607, filed October 13, 2016, entitled “Collection of Fluid Components,” the entire contents of which are incorporated herein by reference as if fully set forth herein. Background Technology

[0004] Separation processes are commonly used in various technical fields to separate components of multi-component fluids. For example, blood components are typically separated from whole blood for transfusion or therapeutic purposes. Apheresis is an example of a blood separation process in which components are separated from whole blood.

[0005] In some separation processes, the purity of the components separated from a multi-component fluid may be important. For example, some apheresis procedures are performed to collect a target component (e.g., platelets) from blood for subsequent therapeutic uses. In these separation processes, it may be important to collect as much of the target component (e.g., platelets) and as few other components (e.g., leukocytes) as possible. Providing a mechanism for controlling the purity of the collected target component during the separation process may be useful.

[0006] Furthermore, separation processes such as apheresis can be performed on blood donors in real time. Therefore, it may be preferable for blood donors to complete the process as quickly as possible. Consequently, an efficient separation process needs to be performed, and the component products should be collected as free of other components as possible.

[0007] Embodiments of the invention have been made with these and other considerations in mind. However, the aforementioned problems do not limit the applicability of the embodiments of the invention to other applications. Summary of the Invention

[0008] The summary is intended to describe aspects of some embodiments of the invention in a simplified manner, and is not intended to identify key or essential elements of the claimed invention, nor to limit the scope of the claims.

[0009] The embodiments provide a method for separating and / or collecting fluid components. The method may provide first data, received by at least one processor, relating to the amount of a first component in a multi-component fluid. An adjustment to be used may be determined based on the first data. The multi-component fluid may then be introduced into a separation container to produce a combined fluid having the components of the multi-component fluid. The combined fluid may then be separated into at least a first component and a second component in a separation chamber. During separation, the concentration of at least one of the first and / or second components in the separation chamber may be maintained below a predetermined amount. The first component may then be collected in a storage container. In embodiments, the multi-component fluid may include whole blood. In some embodiments, the first component may include platelets, wherein the first data includes a platelet count.

[0010] Other embodiments may provide methods for separating and / or collecting components of a biological fluid. Embodiments may provide receiving first data relating to a first amount of a first component in a first multi-component fluid from a first source. A first flow rate may then be determined based on the first data. A first centrifugation speed may then be determined based on the first flow rate. A centrifuge is then rotated at the first centrifugation speed. A flow of a first combined fluid comprising at least a first component and a second component of the first multi-component fluid is introduced into a first separation chamber. The first combined fluid may be separated from the first multi-component fluid. In the separation chamber, the first component of the first combined fluid may be separated from the second component of the first combined fluid by subjecting the first combined fluid to a first-intensity centrifugal force field generated by the centrifuge rotating at the first centrifugation speed. The first component of the first combined fluid may then be collected in a first storage container. Attached Figure Description

[0011] Non-limiting and non-exhaustive embodiments are described with reference to the following figures.

[0012] Figure 1 A separation system according to an embodiment is shown that can be used to separate multi-component fluids (e.g., whole blood) into components.

[0013] Figure 2 The diagram illustrates a catheter and bag assembly in a separation system according to an embodiment that can be used to separate components of a multi-component fluid (e.g., whole blood).

[0014] Figure 3 A perspective view of a centrifuge and separation chamber, according to an embodiment, is shown.

[0015] Figure 4 A cross-sectional view of the container and separation chamber is shown, illustrating the separation of the combined fluid into components.

[0016] Figure 5A cross-sectional view of a separation chamber for separating two particles according to an embodiment is shown.

[0017] Figure 6 A cross-sectional view of a separation chamber for separating two particles according to another embodiment is shown.

[0018] Figure 7 A cross-sectional view of a separation chamber for separating two particles according to yet another embodiment is shown.

[0019] Figure 8 A flowchart of a process for collecting components from a combined fluid, according to an embodiment, is shown.

[0020] Figure 9 A flowchart of a process for collecting components from a combined fluid according to another embodiment is shown.

[0021] Figure 10 A flowchart of a process for collecting components from whole blood according to yet another embodiment is shown.

[0022] Figure 11 A computer system on which some embodiments can be implemented is shown. Detailed Implementation

[0023] The principles of the present invention can be further understood by referring to the embodiments described in the following detailed description and accompanying drawings. It should be understood that although specific features are shown and described below with reference to detailed embodiments, the present invention is not limited to the embodiments described below.

[0024] The following embodiments may be described in relation to the processing of biological fluids containing particulate components (e.g., cells) for the separation and / or collection of components. For example, embodiments may be described in relation to the separation of whole blood into components (e.g., red blood cells, white blood cells, platelets, and plasma). However, this is merely for illustrative purposes. It is important to note that the embodiments are not limited to the description below. The embodiments are intended for use in products, processes, apparatus, and systems that process organic or inorganic particles, microparticles, agglomerates, etc. Accordingly, the embodiments are not limited to the separation or concentration of blood components, but can be used to separate, concentrate, and / or collect any particles from any fluid.

[0025] Figure 1An embodiment of a separation system 100 is shown, which may be used in or in conjunction with the embodiments. In some embodiments, the separation system 100 provides a continuous whole blood separation process. In one embodiment, whole blood is drawn from a donor and supplied substantially continuously to a separation device 104, in which the blood is separated into various components, and at least one of these components is collected. One or more separated components may be collected for subsequent use or returned to the donor. In an embodiment, blood may be drawn from the donor and guided through a bag and catheter assembly 108 and a fluid handling container 116, the bag and catheter assembly 108 including a catheter loop 112, the bag and catheter assembly 108 and the fluid handling container 116 together defining a closed, sterile, disposable system. Assembly 108 may be adapted to be installed in the separation device 104. The separation device 104 includes a pump / valve / sensor assembly 120 connected to the catheter loop 112 and a centrifuge assembly 124 connected to the fluid handling container 116.

[0026] Examples of separation systems can be based on systems used in conjunction with embodiments of the present invention; for example, separation system 100 includes a SPECTRA manufactured by Terumo Bistro Corporation of Lakewood, Colorado. Apheresis system Spectroscopic apheresis system and TRIMA Fully automated blood collection system.

[0027] Centrifuge assembly 124 may include a channel 128 in a rotatable rotor assembly 132 (e.g., a centrifuge), wherein the channel 128 may be used to support a fluid processing container, such as container 116. Rotor assembly 132 may rotate to generate a centrifugal force field. Rotor assembly 132 may be configured to support a chamber for separating, concentrating, and / or washing cells. In one example, when processing whole blood, the cellular components in the blood can be separated from each other and separated from the fluid components of the blood.

[0028] A fluid processing container 116 may be installed within the channel 128. In one example, blood flows substantially continuously from the donor body through the catheter loop 112 and into the rotating fluid processing container 116. Within the fluid processing container 116, the blood can be separated into various blood component types, and at least one of these blood component types (e.g., white blood cells, platelets, plasma, red blood cells, or any combination thereof) can be removed from the fluid processing container 116 for further processing. Blood components not retained for collection or treatment (e.g., red blood cells, platelets, white blood cells, and / or plasma) can also be removed from the fluid processing container 116 and returned to the donor body via the catheter loop 112.

[0029] The operation of the separation device 104 can be controlled by one or more processors included in the device, and may include multiple embedded computer processors that are part of a computer system. The computer system may include various components such as memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical disc drives, flash memory); communication / networking devices (e.g., wired devices such as modems / network cards, or wireless devices such as Wi-Fi); input devices such as keyboards, touchscreens, cameras, and / or microphones; and output devices such as displays and audio systems. In embodiments, the computer system may control one or more pumps, valves, sensors, etc., and may be part of component 120. Embodiments of the separation device 104 may include a graphical user interface 136 with a display (e.g., ...) for cooperation with an operator of system 100. Figure 1 As shown in the diagram, the display includes an interactive touchscreen. In an embodiment, system 100 may implement a computer system (such as those referenced below). Figure 9 One or more features of the computer system (900) described.

[0030] Embodiments of catheter assemblies (e.g., catheter assembly 108) can be similar to those described above. Figure 2 The embodiments shown are used in combination. The catheter assembly may include a cassette 200 and multiple catheter / storage assemblies 202, 204, 206, 208, and 210. Additionally, catheter loops 220, 222, 224, 226, and 228 may engage with a peristaltic pump on a dissociation device (e.g., device 104 and assembly 120) to pump fluid through catheter / storage assemblies 202, 204, 206, 208, and 210. The catheter assembly may also include a container 216 and a chamber 218.

[0031] In an embodiment, Figure 2The catheter assembly shown can be used to separate whole blood into multiple components. In embodiments, some components separated from the whole blood can be returned to the donor, stored in one or more storage containers, or further processed. For example, whole blood can circulate through the catheters in the catheter assembly and enter a fluid processing container 216 mounted on a rotor assembly (e.g., assembly 128). A chamber 218 may also be mounted on the rotor assembly.

[0032] In fluid processing container 216, blood can be separated into multiple components. Some components can be returned to the donor, while others can be further processed. For example, chamber 218 can be used for further processing (concentration or separation) of components. In one embodiment, platelets, plasma, and leukocytes can be guided into chamber 218, where they can be further processed (concentrated, separated, etc.) and then stored in a container (e.g., a bag) or returned to the donor. In some of these embodiments, chamber 218 can be designed to concentrate platelets and produce a platelet product containing as few leukocytes as possible. In other embodiments, red blood cells separated from whole blood can be introduced into chamber 218 and concentrated before being stored in a container (e.g., a bag). These are merely some examples and embodiments of how other components of whole blood or other combined fluids can be separated and concentrated.

[0033] Figure 3 A perspective view of a portion 300 of a separation system is shown, which can be used as, for example, system 100. Figure 1 This is part of a system for separating blood into multiple components. Part 300 includes a centrifuge 304, which may be a centrifuge assembly (e.g., centrifuge assembly 124). Figure 1 Part of the centrifuge 304. The centrifuge 304 spins about the axis of rotation "A". A separation chamber 308 is also shown, which may be an assembly of tubing (e.g., Figure 2 Part of the tubing assembly shown. Centrifuge 304 is connected to motor 312, which causes centrifuge 304 to spin at a very high rotational speed (RPM). Controller 316 may be connected to motor 312 and used to control the speed at which motor 312 causes centrifuge 304 to spin. Controller 316 may include features of a computer system, such as... Figure 11 One or more features of the computer system 1100 shown.

[0034] In one embodiment, centrifuge 304 spins in the direction of arrow 320. In other embodiments, centrifuge 304 may spin in the opposite direction (e.g., counterclockwise). As centrifuge 304 spins, a fluid such as whole blood within channel 324 may be separated into multiple components. In some embodiments, one or more components separated in channel 324 may be further separated in chamber 308. For example, a composition of leukocytes and platelets (e.g., erythrocyte sedimentation rate, amber layer) may be further separated within chamber 308.

[0035] The spin of centrifuge 304 about axis A subject chamber 308 to a centrifugal force field. As described in more detail below, the centrifugal force field can be used to separate leukocytes and platelets. Understandably, the strength of the centrifugal force field can vary depending on how fast centrifuge 304 spins. That is, as centrifuge 304 spins faster, the fluid in channel 324 and chamber 308 experiences a stronger centrifugal force.

[0036] Figure 4 A partial cross-sectional view of one embodiment of a centrifuge 400, container 402, and separation chamber 420, according to an embodiment of the present invention, is shown. Figure 4 In the illustrated embodiment, whole blood 404 is separated into multiple components comprising red blood cells 408, layer 412 (containing platelets and white blood cells), and plasma 416. Platelets are further separated from white blood cells in chamber 420.

[0037] like Figure 4 As shown, pump 424 pumps whole blood 404 through conduit 428 into channel 406 of container 402. In an embodiment, container 402 and therefore channel 406 can be positioned around a channel in centrifuge 400, which spins and separates whole blood 404 into multiple components. Figure 4 On the left, whole blood 404 is shown separated into red blood cells 408, white blood cells / platelets 412, and plasma 416. Notably, plasma may also be present in the red blood cell and white blood cell / platelet layers.

[0038] Pump 432 removes the separated plasma 416 through conduit 436, which may have an inlet facing the top of channel 406. Conduit 440 may have an inlet facing the bottom of channel 406, allowing the removal of red blood cells 408 from channel 406. Finally, conduit 444 is used to remove white blood cells / platelets 412 from channel 406 and allow the white blood cells / platelets 412 to enter chamber 420, in which platelets are separated from white blood cells. In an embodiment, a fluidized bed of microparticles can be created as the white blood cells / platelets move into chamber 420, which facilitates the separation of platelets and white blood cells. Pump 448 may be used to first remove concentrated platelets from chamber 420, and then the separated white blood cells may be removed. Embodiments of methods and systems that can be used to separate platelets from white blood cells are described in more detail below.

[0039] Figure 5 A cross-sectional view of a separation chamber 500 for separating two particles according to an embodiment is shown. In some embodiments, the separation chamber can be used to separate components of a combined fluid. In the following description, Figures 5 to 7 The description is about, for example, in chamber 218 ( Figure 2 ), chamber 308 ( Figure 3 ) and / or chamber 420 ( Figure 4 Platelets are separated from white blood cells in a process called PCR. However, the invention is not limited thereto. In other embodiments, the separated one or more particles may be other components of blood (e.g., red blood cells, specific types of white blood cells, etc.), components of other biological fluids, and / or components of inorganic fluids.

[0040] like Figure 5 As shown, the separation chamber 500 includes a volume 504, a first port 508, and a second port 512. A combined fluid 516 (in this embodiment, a composition of plasma 520, leukocytes 524, and platelets 528) enters the volume 504. A fluid path (e.g., a conduit 532) is connected to port 508 to allow fluid 516 to enter the volume 504. The chamber 500 is subjected to a centrifugal force field as indicated by arrow 536A. As described above, in this embodiment, the conduit 532 is a tubing assembly (e.g., Figure 1 and Figure 2 As part of the catheter assembly, the catheter assembly can be connected to a container (e.g., container 116, container 216) in which whole blood (or other multi-component fluid) can be separated into multiple components, and then a combined fluid 516 containing plasma, platelets and white blood cells can be guided into chamber 500.

[0041] Fluid 516 flows through conduit 532. In an embodiment, fluid 532 may be in fluid communication with a separation container (e.g., container 402) in which whole blood from a source (e.g., a blood donor) can be separated into multiple components, which include the combined fluid 516 flowing from the separation container into chamber 500 through conduit 532. At least one pump may control the flow rate of fluid 516 from conduit 532 into chamber 500 (as indicated by arrow 548). When fluid flows into volume 504, a fluidized bed of particles may be created. When fluid 516 is subjected to a centrifugal force field 536, larger and / or denser particles (e.g., leukocytes 524) may tend to accumulate in the bottom portion 540 of chamber 500. Lighter particles (e.g., platelets 528) may tend to move toward the top portion 544 of chamber 500. After a period of time (e.g., when the process reaches a steady state), less dense platelets 528 can continuously flow out of chamber 500 through port 512, as indicated by arrow 552. Platelets flowing out of chamber 500 can be collected to generate platelets in plasma products. In an embodiment, a collection bag, which may be part of a catheter assembly, can be connected to port 512 to collect platelets 528.

[0042] Without being bound by theory, it is plausible that when the density of the fluid within volume 504 begins to increase, the sedimentation rate of leukocytes 524 can be reduced due to the accumulation of, for example, platelets 528 and leukocytes 524 within volume 504. View 556A shows an enlarged view of a portion of volume 504 located in the top portion 544 of chamber 500. As indicated by arrow 560A, leukocytes 524 exhibit a reduced sedimentation rate, which may be due to the high-density fluid (containing leukocytes and platelets) in the top portion 544. This can cause leukocytes 524 to remain in the top portion 544 of chamber 500. Therefore, when platelets 528 are removed from chamber 500 for collection (e.g., collected in a storage container), these platelets can sweep away leukocytes 524 at a concentration higher than desired.

[0043] Figure 6 Another cross-sectional view of the separation chamber 500 is shown. Figure 5 In the illustrated embodiment, the concentration of one or more of leukocytes 524 and / or platelets 528 has been controlled to ensure that the density of the fluid 516 in volume 504 does not cause the sedimentation rate of leukocytes 524 to exceed a predetermined amount. Without being bound by theory, it is plausible that by keeping the concentration of one or more of leukocytes 524 and / or platelets 528 in volume 504 below a predetermined amount, the sedimentation rate can be kept sufficiently high to ensure that more leukocytes 524 settle into the bottom portion 540 and do not remain in the top portion 544 and flow out with the platelets 528.

[0044] like Figure 6 As shown, the concentration of leukocytes 524 and / or platelets 528 in fluid 516 is lower than Figure 6 The concentrations of white blood cells 524 and / or platelets 528 shown. This can be performed, for example, by controlling the amount of fluid pumped from the source of fluid 516. In one embodiment, whole blood can be drawn from a donor into a container (in which whole blood is separated to produce plasma, red blood cells, and combined fluid 516 (platelets, plasma, and white blood cells)) by a pump (e.g., pump 424). Figure 4 This can reduce the flow rate of the pump, allowing a smaller volume of whole blood to be separated, which can reduce the inflow of white blood cells 524 and / or platelets 528 into chamber 500 in fluid 516. The flow rate 548A through chamber 500 can remain constant.

[0045] As shown in view 556B, an enlarged view of a portion of volume 504 located in the top portion 544 of chamber 500 is presented. The density of the fluid 516 (containing leukocytes and platelets) can be lower, which allows leukocytes 524 to have a high sedimentation velocity, as indicated by arrow 560B. Therefore, fewer leukocytes 524 can remain in the top portion 544 of chamber 500. Accordingly, when platelets 528 flow out of chamber 500 to be collected (e.g., collected in a storage container), these platelets can contain fewer leukocytes 524.

[0046] like Figure 5 and Figure 6 As shown, the embodiment can provide control over the components flowing into the separation chamber (e.g., separation chamber 500). This allows control over the density of the fluid in the separation chamber so that the sedimentation velocity of leukocytes remains sufficiently high to allow leukocytes to settle and not be collected along with platelets.

[0047] In embodiments involving whole blood, for example, the concentration of platelets (and / or white blood cells) is kept below a threshold to ensure that the density of the fluid in the separation chamber does not become too high and to reduce the sedimentation rate of white blood cells to the point that too many white blood cells escape the separation chamber along with the platelets. Initially, the donor's platelet or white blood cell concentration (e.g., count) can be determined. The count can be used to determine how much blood should initially be drawn from the donor and how that count may change (e.g., increase) as the donor loses blood throughout the procedure.

[0048] Some embodiments provide for determining regulation based on data relating to the amount of components in the fluid (e.g., white blood cells and / or platelets). For example, in one embodiment, component counts (e.g., platelet counts) can be used to determine how to regulate the extraction flow rate of the multicomponent fluid introduced into the separation vessel over time.

[0049] In operation, chamber 500 can be used in the separation process to separate whole blood into multiple components to produce at least platelets in the plasma products. Chamber 500 can be used as separation chamber 420 ( Figure 4 The separation chamber 420 can be used in systems such as system 100. Figure 1 The system 100 can separate whole blood into plasma, platelets, white blood cells, and red blood cells, with chamber 500 used to separate platelets from white blood cells. In an embodiment, when chamber 500 is used in apheresis component separation procedures, uncollected components can be returned to the donor.

[0050] As described above, the platelet or white blood cell concentration of the blood donor can be determined (e.g., count). This can be done by testing a sample of the donor's blood, or alternatively, it can be determined automatically, for example, using an optical system. The count can be used to determine regulation. That is, the count can be used to determine how much blood should initially be drawn from the donor, and how that count may change (e.g., increase) as the donor loses blood throughout the procedure.

[0051] The donor can then be connected to system 100 as a whole blood source. For example, whole blood can be drawn from the donor into a separation container (e.g., container 402) using a pump (e.g., pump 424), where the whole blood is separated into plasma, a combined fluid (platelet / leukocyte fraction), and red blood cells. The platelet / leukocyte fraction can then be pumped into separation chamber 500 using a pump (e.g., pump 448).

[0052] Initially, whole blood can be drawn from the donor at a relatively low rate to ensure that the concentration of platelets and / or leukocytes does not increase the density in chamber 500 to a level suitable for sweeping away leukocytes using separated platelets. That is, the sedimentation rate of leukocytes is kept sufficiently high to avoid leaving many leukocytes in the top portion 544 of the chamber. In an embodiment, the density of the fluid in chamber 500 is maintained such that, for example, for every 3 × 10⁻⁶ platelet products collected in a storage container... 11 Of the platelets collected, less than approximately 1 × 10⁹ were collected in the final platelet product. 6 One white blood cell.

[0053] In this embodiment, the amount of blood drawn from the donor can be varied over time to maintain not only the sedimentation rate of leukocytes in chamber 500 but also to minimize the time required for the procedure. The flow rate of fluid through chamber 500 can be kept constant, while the concentrations of platelets and leukocytes can be varied based on the amount of blood drawn from the donor. As an example, when performing the procedure on a donor with a high platelet count, blood can initially be drawn from the donor at a lower rate. As the donor loses platelets, the rate at which blood is drawn from the donor can be increased, for example, proportionally. Increasing the rate at which blood is drawn from the donor can shorten the procedure, but as described above, the leukocyte sedimentation rate is maintained at a certain level throughout the procedure to reduce the number of leukocytes swept into the platelets when they are removed from chamber 500.

[0054] Figure 7 Another cross-sectional view of the separation chamber 500 according to another embodiment is shown. Figure 7 In this process, a procedure is being executed to collect a high-concentration product (e.g., a high-concentration platelet product) of the first component. In this embodiment, the flow rate through chamber 500 can be less than [a certain value]. Figure 5 and Figure 6 The flow rate used is shown as arrow 548B.

[0055] In an embodiment, the flow rate 548B can be determined based on the concentration of the first component in the multi-component fluid and the need to collect concentrated products. To achieve a high concentration of the first component, and... Figure 5 and Figure 6 Compared to the previous process, the flow rate of 548B can be lower. Due to the lower flow rate, the particle concentration in volume 504 can be higher.

[0056] Continuing with the platelet product example, initially, after deciding to perform the collection of concentrated platelet product and determining the chamber flow rate, the force of the centrifugal force field, as indicated by arrow 536, can be determined. In an embodiment, the force of the centrifugal force field can be controlled by the rotational speed of a centrifuge (on which chamber 500 is mounted). In an embodiment, this speed can be determined based on the collection of concentrated platelet product, and the chamber flow rate can be determined based on the concentration of the first component in the combined fluid.

[0057] Without being bound by theory, it is plausible that when collecting concentrated products and selecting the chamber flow rate based on the concentration of the first component in the multicomponent fluid (e.g., platelet or white blood cell count), a lower chamber flow rate may result in a higher component concentration in the chamber. To offset the higher component concentration, the centrifugal force 536B can be lower, causing fewer other components to be swept into the concentrated product. The lower centrifugal force (generated by a lower centrifugal speed) can allow platelets to move toward the top portion 544, as indicated by arrow 560C. Compared to conventional processes that provide the same predetermined centrifugal speed for all processes collecting concentrated products (regardless of chamber flow rate), this embodiment, which provides selection of centrifugation speed based on chamber flow rate, can produce a concentrated product with fewer other particles.

[0058] In this embodiment, concentrated platelet product can be produced, such that for every 3 × 10 11 Platelets, less than approximately 1 × 10⁹ / L 6 White blood cells are collected in the final product of platelet concentrate.

[0059] supply Figures 5 to 7 This is for illustrative purposes only. Other embodiments may provide the separation of other particles (with different sizes and / or densities) from a combined fluid other than blood. For example, embodiments may provide the separation of inorganic particles with different sizes, weights, densities, etc. Similarly, embodiments may provide the separation of other components from blood. For example, embodiments may separate white blood cells from red blood cells. In other embodiments, different types of white blood cells may be separated. Accordingly, the invention is not limited to the above references. Figures 5 to 7 Specific embodiments described.

[0060] Furthermore, while a chamber 500 with one design is shown, other designs may be provided in the embodiments. As shown above, the chamber 500 may have a conical volume. In other embodiments, the chamber 500 may have volumes with different shapes, including but not limited to cubes, spheres, ellipsoids, teardrop shapes, rectangular prisms, etc.

[0061] In embodiments, chamber 500 may include other features that may assist in particle separation. In some embodiments, chamber 500 may be referred to as an LRS chamber and includes one or more features described in any one of U.S. Patents 5,674,173; 6,053,856; 6,334,842; and 7,963,901, the entire contents of which are incorporated herein by reference as if fully set forth herein. For example, in embodiments, as shown and described in U.S. Patent 5,674,173, chamber 500 may have grooved or stepped features on its inner surface. These are merely examples, and the invention is not limited thereto.

[0062] Figure 8 , Figure 9 and Figure 10 Flowcharts 800, 900, and 1000, which can be executed in embodiments of the present invention, are shown. While specific devices for performing the steps in flowcharts 800, 900, and 1000 are described below, the invention is not limited thereto. For example, some steps may be described as being performed by a processor (e.g., processor 1112). Figure 11 )) or chamber (e.g., chamber 500 ( Figures 5 to 7 This is for illustrative purposes only, and flowcharts 800, 900, and 1000 are not intended to be executed by any particular device.

[0063] Flowchart 800 illustrates a process according to an embodiment of the present invention for separating / collecting one or more components from a combined fluid separated from a multi-component fluid. In an embodiment, flowchart 800 may be comprised of, for example, system 100 (… Figure 1 A separation system is implemented to separate one or more components from whole blood. For example, flowchart 800 can be used to separate / collect platelet components separated from whole blood. However, flowchart 800 is not limited to separating / collecting one or more components of whole blood, and in embodiments can be used to separate / collect different types of microparticles.

[0064] Flowchart 800 begins at 804. The process proceeds from 804 to optional step 808, where first data may be received. The first data may indicate the concentration of a component in the multi-component fluid. In embodiments, step 808 may involve several sub-steps. For example, in one embodiment, an operator may input a concentration into a user interface (UI) (e.g., user interface 136). As an example, if the multi-component fluid to be separated into multiple components is whole blood, the data input at step 808 may be the concentration of the blood components. The concentration may be determined by the operator testing or performing some analysis on a whole blood sample. In one embodiment involving whole blood, the data may be the concentration (e.g., count) of platelets or white blood cells in the whole blood.

[0065] In other embodiments, data received at step 808 can be received from an imaging system. For example, the data may be image data captured by one or more cameras. In other embodiments, data can be received from a photodetector that detects light reflected or transmitted by the multi-component fluid and / or separated components. The reflected or transmitted light can be used to calculate concentrations (e.g., platelet or white blood cell counts). In embodiments, a processor (e.g., processor 1112) may be part of a separation device (e.g., device 104). Figure 11 Data can be received at step 808.

[0066] Following step 808, the process proceeds to step 812, where a determination regarding the adjustment is made based on the data received at step 808. In an embodiment, the processor (e.g., processor 1112) Figure 11 This determination can be made. Depending on the specific program being executed, the adjustment can involve how quickly the multi-component fluid is initially drawn from the source and how the rate can be adjusted (e.g., higher) as the program progresses. Therefore, the adjustment determined at step 812 can involve parameters that cause changes in fluid flow (e.g., the flow rate of the fluid drawn from the source). In embodiments, this can be a processor (e.g., processor 1112) that is part of a separation device (e.g., device 104). Figure 11 This adjustment can be determined at step 812.

[0067] Following step 812, step 816 can be performed to introduce the multi-component fluid into the separation container at a predetermined rate. As part of step 816, the combined fluid can be separated from the multi-component fluid at an optional step 820. As an example, as described above, whole blood can be separated into multiple components in a separation container (e.g., container 402). Whole blood can be separated into plasma, platelets / white blood cells, and red blood cells. In an embodiment, the combined fluid separated at step 820 may include platelets containing white blood cells, which were initially separated from whole blood in the separation container. In other embodiments, the combined fluid may include white blood cells and red blood cells.

[0068] Then, process 800 proceeds to 822, where the combined fluid separated from the multi-component fluid in step 820 can be introduced into the separation chamber. In an embodiment, the separation chamber can be designed to separate at least two different types of particles. The flow rate of the combined fluid through the chamber can be kept constant throughout the process. In an embodiment, the fluid introduced into the separation chamber may include one or more components of whole blood, such as plasma, platelets, white blood cells, and / or red blood cells.

[0069] Process 800 proceeds from step 822 to step 824, where the components of the combined fluid are separated. In embodiments, step 824 may involve one or more sub-steps. For example, in one embodiment, a fluidized bed may be generated at an optional step 826. Examples of fluidized beds are... Figures 5 to 7 As shown in the diagram. Optional step 826 can involve any number of steps or structures; for example, the separation chamber can have a design for creating a fluidized bed (e.g., conical volume, stepped sides, etc.). In some embodiments, fluid can be introduced into the separation chamber at appropriate locations and at specific flow rates to assist in establishing a fluidized bed.

[0070] As part of step 824, the fluid may be subjected to a centrifugal force field. Therefore, step 824 may involve a sub-step 828 in which the fluid is subjected to a centrifugal force field. The centrifugal force field can be established, for example, by providing a separator on a system having a rotating centrifuge assembly. As an example, a separation chamber can be installed as referenced above. Figure 1 and Figure 3 The centrifuge assembly shown. As fluid flows through the separation chamber, the centrifuge can rotate, subjecting the fluid to a centrifugal force field. In an embodiment, the centrifuge may be powered by a motor (e.g., motor 312). Figure 3 The centrifuge spins, and the centrifuge can be controlled by a computer system (e.g., controller 316). Figure 3 ))control.

[0071] After step 824, process 800 proceeds to step 832, where the concentration of the component can be maintained at or below a threshold. (See above reference...) Figure 5 and Figure 6 The described process 800 can be used to collect platelets, for example, from plasma. To collect platelets with as few white blood cells as possible, the density of the fluid in the separation chamber can be kept below a predetermined density. (See above reference...) Figure 5 and Figure 6 The density can affect the sedimentation rate of components (e.g., white blood cells). To maintain a specific density, in step 832, the platelet concentration in the separation chamber is maintained, for example, at or below a threshold amount. In an embodiment, to achieve this, the pump drawing whole blood from the source and introducing it into the separation container (e.g., step 816) can be initially slowed down to control the amount of platelets flowing into the separation chamber.

[0072] Step 836 can be performed to change the flow rate of the fluid during the process of process 800. Continuing the example above (regarding step 832), the concentration of platelets in the source (e.g., a blood donor) may initially be high. Therefore, process 800 can initially provide a lower flow rate of the fluid drawn from the blood donor and introduced into the container (e.g., step 816). That is, the flow rate introduced into the separation container at step 816 can be at a first predetermined rate. After a predetermined period of time, the blood donor may lose platelets. At this time, step 836 can provide to change the flow rate of the pump that draws fluid from the blood donor and introduces the fluid into the separation container (e.g., change to a second rate). For example, since the level of lost platelets will not cause the concentration in the separation chamber to exceed a threshold, the pump flow rate can be increased to draw more whole blood for separation. Step 840 can also utilize the adjustment determined at step 812. That is, based on the adjustment determined at step 812, a specific amount can be added to the pump that introduces the multi-component fluid into the separation container after a predetermined period of time starting from the point where the program begins. The flow rate variation can be implemented by a processor (e.g., processor 1112), which can be used to control the extraction flow pump, such as pump 424. Figure 4 ).

[0073] Then, process 800 proceeds to step 844, where a component (e.g., platelets) is collected. In an embodiment, step 844 may involve moving the component from the separation chamber to a storage container for collection. In an embodiment, the component may be collected in a soft storage container (such as, for example, a... Figure 2 (In the bag of a portion of the catheter assembly shown). Then, process 800 ends at 844.

[0074] Flowchart 900 illustrates a process according to an embodiment of the present invention for separating / collecting one or more components from a combined fluid. In an embodiment, flowchart 900 may be comprised of, for example, system 100 (… Figure 1 A separation system is implemented to separate one or more components from whole blood. For example, flowchart 900 can be used to separate / collect concentrated platelet components separated from whole blood. However, flowchart 900 is not limited to separating / collecting one or more components of whole blood, and in embodiments can be used to separate / collect different types of microparticles.

[0075] Flowchart 900 begins at 904. The process proceeds from 904 to step 908, where data may be received. The data may indicate the concentration of one or more components in a multi-component fluid, such as whole blood. In embodiments, step 908 may involve several sub-steps. For example, in one embodiment, an operator may input concentrations into a user interface (UI) (e.g., user interface 136). As an example, if the multi-component fluid to be separated into multiple components is whole blood, the data input at step 908 may be the concentration of blood components. The concentration may be determined by the operator testing a whole blood sample or by some analysis to determine the concentration. In one embodiment involving whole blood, the data may be the concentration (e.g., count) of platelets and / or white blood cells.

[0076] In other embodiments, data received at step 908 can be received from an imaging system. For example, the data may be image data captured by one or more cameras. In other embodiments, data can be received from a photodetector that detects light reflected or transmitted by the multi-component fluid and / or separated components. The reflected or transmitted light can be used to calculate concentrations (e.g., platelet or white blood cell counts). In embodiments, a processor (e.g., processor 1112) may be part of a separation device (e.g., device 104). Figure 11 Data can be received at step 908.

[0077] After step 908, the process proceeds to step 910, where the chamber flow rate of the program is determined based on the data received in step 908. In an embodiment, the processor (e.g., processor 1112) Figure 11This determination can be made. In some embodiments, this determination is made at least in part based on data received at step 908. For example, as described above, the data received at step 908 may relate to the concentration of components in the multicomponent fluid. In one embodiment, if the concentration of components in the multicomponent fluid is low, the chamber flow rate may be lower than if the concentration of components in the multicomponent fluid is high. In other words, the chamber flow rate may be varied between multiple processes based on the concentration of the components separated in the multicomponent fluid. These are merely examples, and the invention is not limited thereto.

[0078] Following step 910, the process proceeds to step 912, where the centrifugation speed of the program is determined based on the chamber flow rate determined in step 910. In an embodiment, the processor (e.g., processor 1112) Figure 11 This determination can be made. In some embodiments, this determination is made at least in part based on the chamber flow rate, which, as described above, is determined at least in part by the data received at step 908. In other words, the centrifugation rate can be varied between multiple procedures based on the chamber flow rate determined at step 910.

[0079] Then, process 900 proceeds to step 916, in which a centrifuge (e.g., centrifuge 124 or centrifuge 304) rotates at the speed determined at step 912. After step 916, the process proceeds to 920, in which the combined fluid may be introduced into the separation chamber at the chamber flow rate determined at step 910. In embodiments, the separation chamber may be designed to separate at least two different types of particles. In some embodiments, the fluid introduced into the separation chamber may be a component of whole blood.

[0080] It is worth noting that in some embodiments, the fluid introduced at step 920 may have previously been separated from the multi-component fluid. Optional step 924 may be performed to separate the combined fluid from the multi-component fluid. As an example, as described above, whole blood can be separated into multiple components in a separation container (e.g., container 402). Whole blood can be separated into plasma, platelets / white blood cells, and red blood cells. In an embodiment, the combined fluid introduced into the separation chamber at step 920 may include platelets containing white blood cells that were initially separated from the whole blood in the separation container.

[0081] Process 900 proceeds from step 920 to step 928, in which the components of the combined fluid are separated. In an embodiment, step 928 may involve one or more sub-steps. As part of step 928, the fluid may be subjected to a centrifugal force field generated by the rotation of a centrifuge at step 916. Therefore, step 928 may involve sub-step 932, in which the fluid is subjected to a centrifugal force field. As the fluid flows through the separation chamber, the centrifuge may spin, thereby subjecting the fluid to a centrifugal force field. In an embodiment, the centrifuge may be powered by a motor (e.g., motor 312). Figure 3 The centrifuge spins, and the centrifuge can be controlled by a computer system (e.g., controller 316). Figure 3 ))control.

[0082] Alternatively, a fluidized bed can be generated at optional step 936. An example of a fluidized bed is shown in... Figures 5 to 7 As shown in the diagram. Optional step 936 can utilize a structure, for example, the separation chamber can have a specific design for generating a fluidized bed (e.g., conical volume, stepped sides, etc.). In some embodiments, fluid can be introduced into the separation chamber at appropriate locations and at specific flow rates to assist in establishing a fluidized bed.

[0083] Then, process 900 proceeds to step 940, in which a component (e.g., platelets) is collected. In an embodiment, step 940 may involve moving the component from the separation chamber to a storage container for collection. In an embodiment, the component may be collected in a soft storage container (such as, for example, a... Figure 2 (In the bag of a portion of the catheter assembly shown). Then, process 900 ends at 944.

[0084] Flowchart 1000 illustrates aspects of combining processes 800 and 900 according to embodiments of the present invention, for separating / collecting one or more components from a combined fluid separated from whole blood. In embodiments, flowchart 1000 may be derived from systems such as system 100 (… Figure 1 The separation system is implemented to perform apheresis procedures for collecting a product comprising components of whole blood. In an embodiment, the product may be standard platelets (e.g., approximately 1500 × 10⁻⁶ per microliter) from plasma products. 3 Platelets (e.g., approximately 4000 × 10⁶ per microliter) or concentrated platelets in plasma products (e.g., approximately 4000 × 10⁶ per microliter). 3 (platelets). In other embodiments, other products may also be collected, and these other products may include other components of whole blood, such as red blood cells and / or white blood cells.

[0085] Flowchart 1000 begins at 1004. The process proceeds from 1004 to step 1008, where data and instructions regarding the procedure may be received. As described in more detail below, the procedure may be a first procedure for collecting a product comprising whole blood components, or a second procedure for collecting a concentrated product comprising a more concentrated amount of whole blood components. Additionally, the data received at step 1008 may relate to the concentration of components in the whole blood. For example, in an embodiment, the data may relate to platelet or white blood cell counts. In an embodiment, step 1008 may involve several sub-steps. For example, in one embodiment, an operator may input the procedure and / or data into a user interface (UI) (e.g., user interface 136).

[0086] In some embodiments, data received at step 1008 can be received from an imaging system. For example, the data may be image data captured by one or more cameras. In other embodiments, data can be received from a light detector that detects light reflected or transmitted by whole blood and / or separated components. The reflected or transmitted light can be used to calculate concentrations (e.g., platelet or white blood cell counts). In embodiments, a processor (e.g., processor 1112) may be part of a separation device (e.g., device 104). Figure 11 Data can be received at step 1008.

[0087] After step 1008, the process proceeds to decision 1012, where it is determined what program was received in step 1008. In an embodiment, the processor (e.g., processor 1112) Figure 11 This determination can be made. If the determination at point 1012 indicates a first procedure, the process proceeds to step 1016. In an embodiment, the first procedure may be used to collect a product of platelets having a standard concentration in plasma.

[0088] At step 1016, a determination regarding the adjustment is made based on the data received at step 1008. In an embodiment, the processor (e.g., processor 1112) Figure 11 This determination can be made. Adjustments may involve how quickly whole blood is initially drawn from the donor and how the rate can be adjusted (e.g., higher or lower) as the procedure progresses.

[0089] After step 1016, step 1020 can be performed to rotate the centrifuge. In an embodiment, the centrifuge can rotate at a first predetermined speed. In an embodiment, the first predetermined speed can be the same for any procedure performed to produce a product with a standard concentration of platelets in plasma.

[0090] Following step 1020, whole blood may be introduced into a separation container at a first predetermined rate at step 1024. As part of step 1024, the combined fluid may be separated from the whole blood at an optional step 1028. The whole blood may be separated into multiple components in a separation container (e.g., container 402). The whole blood may be separated into plasma, platelets / white blood cells (e.g., the combined fluid), and red blood cells.

[0091] Then, process 1000 proceeds to step 1032, in which the combined fluid (e.g., platelets / leukocytes) separated in step 1028 is introduced into the separation chamber. In step 1036, the combined fluid is separated into a first component and a second component in the separation chamber.

[0092] In an embodiment, step 1036 may involve one or more sub-steps. As part of step 1036, the fluid may be subjected to a centrifugal force field generated by the rotation of the centrifuge at step 1020. The centrifuge may spin as the fluid flows through the separation chamber, thereby subjecting the fluid to a centrifugal force field. In an embodiment, the centrifuge may be powered by a motor (e.g., motor 312). Figure 3 The centrifuge spins, and the centrifuge can be controlled by a computer system (e.g., controller 316). Figure 3 ))control.

[0093] Alternatively, a fluidized bed can be generated at optional step 1044. An example of a fluidized bed is shown in... Figures 5 to 7 As shown in the diagram. Optional step 1044 can utilize a structure, for example, the separation chamber can have a specific design for generating a fluidized bed (e.g., conical volume, stepped sides, etc.). In some embodiments, fluid can be introduced into the separation chamber at appropriate locations and at specific flow rates to assist in establishing a fluidized bed.

[0094] Then, process 1000 can proceed to step 1048, in which the concentration of the component can be maintained at or below a threshold. In the case of platelet collection, in order to collect platelets with as few white blood cells as possible, the density of the fluid in the separation chamber can be maintained below a predetermined density. (Refer to the above...) Figure 5 and Figure 6 The density may affect the sedimentation rate of components (e.g., white blood cells). To maintain the density at an appropriate level, at step 1048, the platelet concentration in the separation chamber is maintained, for example, at or below a threshold amount. In an embodiment, to achieve this, the pump drawing blood from the donor and entering the separation container (at step 1024) may be initially slowed down to control the amount of platelets flowing into the separation chamber.

[0095] Following step 1048, step 1052 can be performed to change the flow rate of the whole blood introduced at step 1024. Continuing the example above (referring to step 1048), the donor's platelet concentration may initially be high. Therefore, process 1000 can initially provide a lower flow rate of whole blood drawn from the donor and entering the container. That is, the flow rate introduced into the separation container at step 1024 can be at a first predetermined rate. After a predetermined period of time, the donor may lose platelets. At this time, step 1052 can provide to change the flow rate of the pump drawing fluid from the donor and introducing the fluid into the separation container (e.g., a second flow rate). For example, since the lost platelet level will not cause the concentration in the separation chamber to exceed a threshold, the pump flow rate can be increased to draw more whole blood for separation. Step 1052 can utilize the adjustment determined at step 1016. That is, based on the adjustment determined at step 1016, a specific amount can be added to the pump introducing whole blood into the separation container after a predetermined period of time starting from the point where the program begins. The flow rate variation can be implemented by a processor (e.g., processor 1112), which can be used to control the extraction flow pump, such as pump 424. Figure 4 ).

[0096] Then, process 1000 proceeds to step 1056, in which components (e.g., platelets) are collected. In an embodiment, the components may be collected in a soft storage container (such as, for example, a... Figure 2 (as shown in the bag of a portion of the catheter assembly). Then, process 1000 ends at 1060.

[0097] Returning to reference decision 1012, if the decision indicates the program is a second program, process 1000 proceeds to step 1062. At step 1062, the chamber flow rate for the program is determined. In embodiments, this determination may be performed by a processor (e.g., processor 1112). In some embodiments, this determination is based at least in part on data received at step 1008. For example, as described above, the data received at step 1008 may relate to the concentration of components in whole blood (e.g., platelet count, white blood cell count, etc.). In one embodiment, if the concentration of a component in whole blood is low, the flow rate may be lower than if the concentration of a component in whole blood is high. In other words, the chamber flow rate may vary between programs based on the concentration of the separated components in whole blood. These are merely examples, and the invention is not limited thereto.

[0098] At step 1064, a centrifuge speed for the program is determined. In an embodiment, the processor may perform this determination. In some embodiments, this determination is based at least in part on the chamber flow rate determined at step 1062. In one embodiment, if the chamber flow rate is relatively low, the centrifuge speed may be lower than the centrifuge speed if the chamber flow rate is high.

[0099] Then, process 1000 proceeds to step 1068, in which a centrifuge (e.g., centrifuge 124 or centrifuge 304) rotates at the speed determined at step 1064. After step 1068, process 1000 proceeds to step 1072, in which whole blood may be introduced into a separation container. As part of step 1072, the combined fluid may be separated from the whole blood at an optional step 1076. The whole blood may be separated into multiple components in a separation container (e.g., container 402). The whole blood may be separated into plasma, platelets / white blood cells (e.g., the combined fluid), and red blood cells.

[0100] Then, process 1000 proceeds to step 1080, in which the combined fluid (e.g., platelets / leukocytes) separated in step 1076 is introduced into the separation chamber at a flow rate determined in step 1062. In step 1084, the combined fluid is separated into a first component and a second component in the separation chamber.

[0101] In an embodiment, step 1084 may involve one or more sub-steps. As part of step 1084, the fluid may be subjected to a centrifugal force field generated by the rotation of the centrifuge at step 1088. The centrifuge may spin as the fluid flows through the separation chamber, thereby subjecting the fluid to a centrifugal force field. In an embodiment, the centrifuge may be powered by a motor (e.g., motor 312). Figure 3 The centrifuge spins, and the centrifuge can be controlled by a computer system (e.g., controller 316). Figure 3 ))control.

[0102] Alternatively, a fluidized bed can be generated at optional step 1092. An example of a fluidized bed is shown in... Figures 5 to 7 As shown in the diagram. Optional step 1092 can utilize a structure, for example, the separation chamber can have a specific design for generating a fluidized bed (e.g., conical volume, stepped sides, etc.). In some embodiments, fluid can be introduced into the separation chamber at appropriate locations and at specific flow rates to assist in establishing a fluidized bed.

[0103] Then, process 1000 proceeds to step 1096, in which components (e.g., platelets) are collected. In an embodiment, the components may be collected in a soft storage container (such as, for example, a... Figure 2(as shown in the bag of a portion of the catheter assembly). Then, process 1000 ends at 1060.

[0104] Although processes 800, 900, and 1000 are described as having steps listed in a specific order, the invention is not limited thereto. In other embodiments, steps may be performed in a different order, in parallel, or with any number of different times, for example, before and after another step. Furthermore, as described above, processes 800, 900, and 1000 may include some optional steps / sub-steps. However, those steps not indicated as optional should not be considered essential to the invention, but may be performed in some embodiments of the invention and not in others.

[0105] Figure 11 Example components of a basic computer system 1100 on which embodiments of the present invention can be implemented are shown. For example, system 104 ( Figure 1 ) and / or controller 316 ( Figure 3 ) can contain Figure 11 The basic computer system 1100 shown in the diagram has the following features. The computer system 1100 includes one or more output devices 1104 and one or more input devices 1108. Additionally, the one or more output devices 1104 may include one or more displays, including CRT (cathode ray tube) displays, LCD (liquid crystal display) displays, and / or plasma displays. The one or more output devices 1104 may also include printers, speakers, etc. The one or more input devices 1108 may include, but are not limited to, keyboards, touch input devices, mice, voice input devices, scanners, etc.

[0106] According to embodiments of the present invention, the basic computer system 1100 may further include one or more processors 1112 and memory 1116. In embodiments, the one or more processors 1112 may be operable general-purpose processors that execute processor-executable instructions stored in memory 1116. According to embodiments, the one or more processors 1112 may include a single processor or multiple processors. Additionally, in embodiments, each processor may be a single-core processor or a multi-core processor, each processor having one or more cores to read and execute individual instructions. In embodiments, the processor may include a general-purpose processor, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), and other integrated circuits.

[0107] Memory 1116 may include any tangible storage medium for short-term or long-term storage of data and / or processor-executable instructions. Memory 1116 may include, for example, random access memory (RAM), read-only memory (ROM), or electrically erasable programmable read-only memory (EEPROM). Other storage media may include, for example, CD-ROM, tape, digital universal disc (DVD) or other optical storage, magnetic disk storage, magnetic tape, other magnetic storage devices, etc.

[0108] Storage component 1128 can be any long-term data storage device or component. Storage component 1128 may include one or more devices described above with reference to memory 1116. Storage component 1128 may be permanent or removable.

[0109] Computer system 1100 also includes communication device 1136. Device 1136 allows system 1100 to communicate over a network (e.g., wide area network, local area network, storage network, etc.), and device 1136 may include multiple devices such as modems, hubs, network interface cards, wireless network interface cards, routers, switches, bridges, gateways, wireless access points, etc.

[0110] Components of computer system 1100 such as Figure 11 The components of system 1100 are connected via system bus 1140. However, it is worth noting that in other embodiments, the components of system 1100 may be connected using more than a single bus.

[0111] In the embodiment, the separation device 104 ( Figure 1 This may include aspects of system 1100. In these embodiments, memory 1116 may store regulation 1120, such as flow rate regulation, centrifuge regulation, etc. In other embodiments, storage component 1128 may store data 1132 indicating, for example, the concentration of a component in a combined fluid.

[0112] It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and structures of this invention without departing from the scope of the invention. Therefore, it should be understood that the invention is not limited to the given embodiments. Rather, the invention is intended to cover modifications, variations, and equivalents.

[0113] Although exemplary embodiments and applications of the invention have been shown, it should be understood that the invention is not limited to the exact configurations shown in the drawings or described above. It will be apparent to those skilled in the art that various modifications, alterations, and variations can be made to the arrangement, operation, and details of the methods and systems disclosed herein without departing from the scope of the invention.

Claims

1. A separation system, comprising: A separation device configured to separate a first component from a multi-component fluid; A pump configured to pass the multi-component fluid through the separation device; as well as A controller configured to start the pump; in The controller is configured to determine the concentration of the second component in the multi-component fluid, the separation device, or a combination thereof; The controller is configured to predict the aggregation of the second component in the separation device based at least in part on the determined concentration of the second component; and The controller is configured to adjust the pump flow rate when the predicted aggregation exceeds a threshold.

2. The fluid separation system according to claim 1, wherein, The multi-component fluid is blood.

3. The fluid separation system according to claim 2, wherein, The second component is platelets, white blood cells, or a combination thereof.

4. The fluid separation system according to claim 3, wherein, The second component is platelets; and The controller is configured to predict the likelihood of platelet aggregation in the separation device based at least in part on the determined amount of platelets.

5. The fluid separation system according to claim 1, further comprising an imaging system configured to output imaging data to the controller, wherein, The controller is configured to determine the concentration of the second component based on the reflected or transmitted light indicated by the imaging data.

6. The fluid separation system of claim 1, further comprising a user interface configured to output data to the controller, wherein the controller is configured to determine the concentration of the second component based on the output data.

7. The fluid separation system of claim 1, further comprising a separation container configured to receive the multi-component fluid, wherein, The first component is separated from the multi-component fluid within the separation container.

8. The fluid separation system of claim 7, further comprising a separation chamber configured to receive the first component from the separation container, wherein, The particles are separated from the first component in the separation chamber.

9. The fluid separation system according to claim 8, wherein, The particles include platelets.

10. The fluid separation system according to claim 1, wherein, The first component is plasma, platelets, white blood cells, red blood cells, or a combination thereof.

11. A method for separating a first component from a multi-component fluid in a fluid separation system, the fluid separation system comprising separation equipment for separating the first component from the multi-component fluid, the method comprising: Multi-component fluid is received through the inlet of the separation device; The multi-component fluid is pumped through the separation device using a pump; The pump is started using a controller to control the flow of the multi-component fluid through the inlet and through the separation device; The concentration of the second component in the multi-component fluid is determined by the controller; The controller predicts the aggregation of the second component in the separation device based at least in part on the determined concentration of the second component; as well as When the predicted aggregation exceeds a threshold, the flow rate of the pump is adjusted using the controller.

12. The method according to claim 11, wherein, The multi-component fluid is blood.

13. The method according to claim 12, wherein, The second component is platelets, white blood cells, or a combination thereof.

14. The method according to claim 13, wherein, The second component is platelets; and Predicting the aggregation of the second component in the separation device via the controller includes predicting the likelihood of platelet aggregation in the separation device based at least in part on the determined amount of platelets.

15. The method of claim 11, further comprising: Imaging data from the imaging system is provided to the controller; The concentration of the second component is determined by the controller, which includes determining the concentration of the second component based on the reflected or transmitted light indicated by the imaging data.

16. The method of claim 11, further comprising: Provide output data to the controller from the user interface; Determining the concentration of the second component by the controller includes determining the concentration of the second component based on the output data.

17. The method of claim 11, further comprising: Within the separation container, the first component is separated from the multi-component fluid.

18. The method of claim 17, further comprising: The first component from the separation container is received in the separation chamber; as well as The particles are separated from the first component in the separation chamber.

19. The method according to claim 18, wherein, The particles include platelets.

20. The method according to claim 11, wherein, The second component is red blood cells.

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