Systems and methods for generating AC volume recommendations for plasma collection
Patent Information
- Application Number
- JP2023544362
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-01-25
- Filing Date
- 2022-01-20
- Publication Date
- 2025-01-28
AI Technical Summary
Existing plasmapheresis procedures face challenges in determining the required volume of anticoagulant needed for each donor, leading to potential interruptions and increased costs due to the need for multiple containers or donor discomfort.
A method and system that estimate the total amount of anticoagulant required based on donor-specific characteristics, such as weight and hematocrit, to ensure a single container is attached before the procedure, proactively alerting operators when additional anticoagulant is needed.
Ensures a seamless plasmapheresis process by avoiding interruptions and reducing donor discomfort while optimizing costs by using a single anticoagulant container, thereby enhancing procedural efficiency and safety.
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Abstract
Description
[Technical field]
[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 141,075, filed January 25, 2021, the contents of which are incorporated herein by reference.
[0002] [Technical field] The present application relates to systems and methods for performing plasma exchange, and more particularly to plasma exchange systems and methods in which an estimate of the total volume of anticoagulant required for the procedure is predetermined based on donor-specific characteristics, and a container of anticoagulant with a sufficient volume for the entire procedure is connected to the system prior to the start of the procedure. [Background technology]
[0003] Plasma exchange is an apheresis procedure in which whole blood is drawn from a donor, the plasma is separated and retained from the cellular blood components (red blood cells, platelets, and white blood cells), and the cellular blood components are returned to the donor. Separation of the plasma from the cellular components is usually performed in automated procedures by centrifugation or membrane filtration.
[0004] In automated plasma exchange, whole blood is drawn from a donor, mixed with an anticoagulant ("AC") in specific ratios, and then separated into anticoagulated plasma, red blood cells, and other cellular components.
[0005] The volume of plasma that can be collected during a plasma exchange procedure varies from donor to donor. Furthermore, the volume of plasma that can be collected from any particular donor can be determined in a number of different ways based on various donor-specific characteristics.
[0006] Methods for determining the volume of raw plasma that can be collected from any particular donor while being consistent with donor safety and comfort typically involve estimating / determining the donor's total blood volume using donor-specific characteristics and then determining the total volume of raw plasma that can be collected from that donor. See, for example, WO2019 / 226654, filed October 23, 2020, and U.S. Patent Application No. 17 / 078,824, both of which are incorporated herein by reference, to optimize plasma collection volumes based on using donor-specific characteristics to determine a target collection volume of the donor's raw plasma.
[0007] As will be appreciated, the volume of anticoagulant required for a particular plasma exchange procedure depends on the amount of raw plasma to be collected. Since this volume will vary from donor to donor, it is desirable to ensure that a single container holding a sufficient volume of anticoagulant for the entire collection procedure is connected to the system at the start. Otherwise, the operator may need to pause the procedure to replace the anticoagulant container, which may increase the procedure time (potentially increasing donor discomfort or causing a donor reaction) and may also increase the expense of using multiple containers of anticoagulant. The present application provides a method and system that estimates the total amount of anticoagulant required for a plasma collection procedure and proactively alerts the operator to obtain additional anticoagulant containers. This facilitates replacement of the original anticoagulant container before or as soon as the anticoagulant runs out, or the use of a single container of anticoagulant in the plasma exchange procedure. Summary of the Invention
[0008] This application has several aspects. In a first aspect, a method for performing plasmapheresis using a fluid flow circuit and a blood separator is provided, the method comprising determining the total blood volume (TBV) of a donor, determining the volume of plasma (VP) to be collected from the donor based on donor-specific characteristics, determining the volume of anticoagulant (VACP) to be collected with the volume of plasma VP, calculating the volume of anticoagulant (VACR) to be returned to the donor based on the separation efficiency of the blood separator, calculating the total volume of anticoagulant (VACT) to be used, and either i) providing one or more containers of anticoagulant containing at least VACT for attachment to the fluid flow circuit, or ii) attaching a single container of anticoagulant containing at least VACT to the fluid flow circuit, wherein the recited steps are performed before connecting the donor to the fluid flow circuit.
[0009] In a second aspect, donor-specific characteristics include weight and hematocrit. The hematocrit may be a default value representing the worst case, such as a hematocrit of 54%. Alternatively, the hematocrit may be the measured hematocrit of the donor.
[0010] In a third aspect, donor-specific variables include weight, height, and hematocrit.
[0011] In a fourth aspect, donor-specific variables include weight, height, gender, and hematocrit.
[0012] In a fifth aspect, one or more containers or a single container contains 250 mL of anticoagulant if VACT < 250 mL, 500 mL of anticoagulant if 250 mL < VACT < 500 mL, 750 mL of anticoagulant if 500 mL < VACT < 750 mL, and 1000 mL of anticoagulant if 750 mL < VACT < 1000 mL.
[0013] In a sixth embodiment, VACP=VP / (1+ACR×(1−Hct / 100)), where ACR is the anticoagulant to whole blood ratio and Hct is the donor's hematocrit.
[0014] In a seventh embodiment, the separation efficiency of the blood separator is based at least in part on the hematocrit of the donor.
[0015] In an eighth aspect, the separation efficiency of the blood separator is based, at least in part, on the anticoagulant to whole blood ratio (ACR) used.
[0016] In a ninth embodiment, VACT = VACP + VACR. Alternatively, VACT may be based on an estimated volume of whole blood that is processed to reach a volume of plasma to be collected, which is based on the separation efficiency.
[0017] In a tenth embodiment, the VACT further comprises a volume of anticoagulant that is used to prime the fluid flow circuit and the blood separator.
[0018] In an eleventh embodiment, VACT is increased to provide a safety margin, such that VACT is increased from 25 mL to 50 mL.
[0019] In a twelfth aspect, an automated system for separating plasma from whole blood is provided, the automated system comprising a disposable fluid flow circuit including a separator for separating the whole blood into a plasma fraction and an enriched cell fraction, and a reusable hardware component comprising a programmable controller having a touch screen for receiving input from an operator, and configured to provide a calculation of the total volume of anticoagulant required for treatment based on the operator's input.
[0020] In the 13th aspect, the programmable control unit calculates the total blood volume (TBV) of the donor, the volume of plasma (VP) to be collected from the donor based on donor-specific characteristics, the volume of anticoagulant (VACP) collected together with the plasma volume VP, the volume of anticoagulant (VACR) returned to the donor based on the estimated separation efficiency of the separator, and the total volume of anticoagulant used (VACT), where VACT = VACP + VACR, and is configured to display VACT on the touch screen.
[0021] In the 14th aspect, the control unit is further configured to make a recommendation regarding the volume of a single container of anticoagulant attached to the disposable fluid flow circuit based on VACT. When VACT < 250 mL, it is recommended to provide a single container or multiple containers containing 250 mL of anticoagulant; when 250 mL < VACT < 500 mL, 500 mL of anticoagulant; when 500 mL < VACT < 750 mL, 750 mL of anticoagulant; and when 750 mL < VACT < 1000 mL, 1000 mL of anticoagulant.
[0022] Other aspects will become apparent with reference to the following description and the accompanying drawings.
Brief Description of the Drawings
[0023] FIG. 1 is a perspective view of an exemplary plasmapheresis device suitable for use in the system and method of the present application.
[0024] FIG. 2 is a perspective view of a type of rotary membrane separator incorporated in a disposable set that can be used in the plasmapheresis system of FIG. 1, with a portion broken away to show details.
[0025] FIG. 3 is a perspective view of the front panel of the plasmapheresis system of FIG. 1, showing the components of the disposable set attached thereto.
[0026] FIG. 4 is a schematic diagram showing the operation of the plasmapheresis system during the collection phase.
[0027] FIG. 5 is a schematic diagram showing the operation of the plasma exchange system during the reinfusion phase.
[0028] FIG. 6 is a flow chart illustrating the steps of the method according to the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] A more detailed description of the systems and methods according to the present disclosure is provided below. It should be understood that the following description of specific devices and methods is for illustrative purposes and does not exhaust all possible variations or applications. Thus, the scope of the present disclosure is not intended to be limiting, but should be understood to encompass variations or embodiments that may occur to those skilled in the art.
[0030] In the context of the present application, plasma exchange is performed on an automated system comprising hardware components, generally designated 10, for collecting plasma, and a disposable set, generally designated 12. As described in more detail below with reference to Figures 1-5, the disposable set 12 consists of integrally connected separators, containers, and tubing for transporting blood and solutions within a sterile fluid pathway.
[0031] The separator 14, best shown in FIG. 2, has a spinning membrane filter 16 attached to a rotor 18 that rotates within a case 20 to separate the blood into components. A detailed description of spinning membrane separators can be found in U.S. Patent No. 5,194,145 to Schondorfer, which is incorporated herein by reference. As will be appreciated, in alternative systems, separation of whole blood can be accomplished by centrifugation. See, for example, U.S. Patent No. 5,360,542 to Williamson et al.
[0032] During plasma exchange, whole blood is drawn from a donor, anticoagulant is added, and then the anticoagulated whole blood enters separator 14 through whole blood input port 22. Plasma is separated by a spinning membrane filter and exits plasma output port 24 through plasma line 26 into plasma collection container 28. Enriched cells are pumped out enriched cell output port 30 into reservoir 32 where the cells remain until reinfused into the donor. As will be appreciated, a portion of the anticoagulant added to the whole blood remains in the separated plasma, while another volume of anticoagulant remains with the enriched cells.
[0033] The disposable set 12 includes tubing lines for introducing whole blood from a donor into the system during collection and returning concentrated cells to the donor during reinfusion (donor line 34 terminating in venipuncture needle 36), tubing lines for transporting anticoagulated whole blood to a separator (blood line 38), tubing lines for transporting concentrated cells to a reservoir (cell line 40), tubing lines for transporting concentrated cells from the reservoir to the donor line (reinfusion line 42), tubing lines for transporting plasma to a plasma collection container (plasma line 44), tubing lines for transporting saline (saline line 46), and tubing lines for transporting anticoagulant (AC line 48).
[0034] The hardware components 10 include a programmable control 50 and a touch screen 52 with a graphical user interface ("GUI") through which an operator controls the procedure. For example, the GUI allows for entry of any of the following: donor ID, donor gender, donor height, donor weight, donor age, donor hematocrit / hemoglobin, target saline infusion volume (if a saline protocol is selected), and target plasma volume. The touch screen 52 also allows the operator to gather status information and handle error conditions.
[0035] Three peristaltic pumps are located on the front panel of the hardware component 10, including an AC pump 54, a blood pump 56, and a cell pump 58. The AC pump 54 delivers anticoagulant solution (AC) at a controlled rate to the blood line 38 as whole blood enters the set from the donor. The blood pump 56 pumps anticoagulated whole blood to the separator during the collection phase of the procedure and returns concentrated cellular components and, if necessary, replacement fluid to the donor during the reinfusion phase of the procedure. The cell pump 58 delivers concentrated cellular components from the separator 14 to the reservoir during the collection phase.
[0036] The front panel also includes four clamps to which the disposable set 12 is attached, including a reinfusion clamp 60, a blood clamp 62, a saline clamp 64, and a plasma clamp 66. The reinfusion clamp 60 closes during the collection phase (FIG. 5) to block the reinfusion line (42) and opens during the reinfusion phase (FIG. 6) to allow the blood pump to reinfuse concentrated cellular components from the reservoir 32 to the donor. The blood clamp 62 opens during the collection phase to allow anticoagulated whole blood to be sent to the separator 14 and closes during the reinfusion phase to block the blood line 38. The saline clamp 64 closes to block the saline line 46 during the collection phase and during reinfusion of the separated cellular components. If saline is used as the replacement fluid, the saline clamp 64 opens during the reinfusion phase. The plasma clamp 66 opens during the collection phase to allow plasma to flow into the plasma collection container 28 and closes during the reinfusion phase.
[0037] The hardware components 10 include three weigh scales for monitoring the current plasma collection volume (weigh scale 68), the AC solution volume (weigh scale 70), and the concentrated cellular component volume (weigh scale 72). The system also includes various sensors and detectors, including a venous pressure sensor 74, a separator pressure sensor 76, an optical blood detector 78, and an air detector 80.
[0038] The donor is connected to the system throughout the procedure. As shown, the disposable set 12 includes a single venipuncture needle 36 through which whole blood is drawn from the donor in a collection phase (FIG. 4) and enriched cells are returned to the donor in a reinfusion phase (FIG. 5). As discussed above, the plasma exchange procedure includes multiple cycles, each cycle having a recovery / separation phase followed by a return or reinfusion phase. In the collection phase, the whole blood is separated into plasma and enriched cells. The disposable set includes a plasma collection container 28 for receiving the separated plasma and a reservoir 32 for receiving the enriched cells. In the reinfusion phase, the enriched cells from the reservoir 32 are reinfused into the donor through the venipuncture needle 36. Typically, plasma exchange therapy performed using a single venipuncture needle 36 includes multiple cycles of collection and reinfusion.
[0039] 4, during the collection phase, an anticoagulant solution (AC) is pumped at a controlled rate and mixed with the whole blood entering the disposable set 12. The anticoagulated blood is sent to separator 14 where the plasma is separated from the cellular components and sent to a plasma collection container 28.
[0040] The cellular components are pumped from the separator 14 to a reservoir 32. The collection phase stops when the reservoir 32 reaches the expected volume of concentrated cells or when the target plasma collection volume is achieved.
[0041] The reinfusion phase then begins. Referring to Figure 5, during the reinfusion phase, the blood pump 56 reverses direction and pumps the concentrated cells from the reservoir 32 back through the apheresis needle 36 to the donor. If a saline protocol is selected, saline is returned to the donor as a replacement for the collected plasma, and saline is infused after the final reinfusion phase.
[0042] In line with the present application, an estimated volume of anticoagulant required for the procedure is determined so that a single container of anticoagulant can be connected to the disposable set 14 before the start of the procedure. To this end, the donor's total blood volume (TBV) and the amount of plasma that can be collected from the donor are determined using donor-specific characteristics. For this purpose, various nomograms can be employed.
[0043] The donor specific characteristics used include at least the donor's weight and hematocrit, as the hematocrit is necessary to determine the percentage of anticoagulant that is collected with the plasma in the plasma product container. The hematocrit may be a default value, such as a "worst case" where the donor's hematocrit is assumed to be 54%, or the donor's hematocrit may be determined using any number of well-known methods, such as by using a dedicated hematocrit centrifuge (e.g., SciLogex DM4124 hematocrit centrifuge) or a hematology analyzer (e.g., Sysmex XP-300TM automated hematology analyzer).
[0044] Donor hematocrit may also vary as a function of the amount of plasma collected during the plasma exchange procedure. More specifically, the donor's hematocrit will be higher in the later portions of the procedure because the donor loses plasma as the procedure progresses. Thus, more anticoagulant will be required than the initial estimate based on the donor's initial hematocrit. Thus, the anticoagulant estimate based on the donor's initial hematocrit may be increased to account for the increased hematocrit.
[0045] As an example, if a donor's total blood volume is determined to be 5000 mL and the donor's hematocrit at the start of the procedure is 40%, then red blood cells will make up 2000 mL and plasma will make up 3000 mL. After 500 mL of plasma is collected and the associated red blood cells are reinfused into the donor, the donor's total blood volume will be 4500 mL, with 2000 mL of red blood cells and 2500 mL of plasma, resulting in a hematocrit of 44.4% (2000 mL / (2000 mL+2500 mL)), i.e., a 4.4% increase in hematocrit. The increase in hematocrit is a function of the donor's size (larger donors with more total blood volume and therefore more total plasma volume will see less of a change in hematocrit) and how much plasma was collected. The increase in hematocrit will increase the amount of anticoagulant required for subsequent plasma collections. Therefore, based on the targeted plasma collection volume, the donor's "final" hematocrit can be estimated, which will be higher than the initial hematocrit. The hematocrit for the entire procedure can be based on the average between the donor's initial and final hematocrit, and the average value used in determining the total amount of anticoagulant needed for the plasma collection procedure. The amount of anticoagulant returned to the donor with the red blood cells may also be considered in determining the average hematocrit during the procedure, as this will lower the donor's hematocrit.
[0046] The donor specific characteristics may be entered into the controller by an operator using a touch screen, or alternatively, the donor specific characteristics may be provided to the controller through a data management system that includes a database containing such information.
[0047] If donor weight and hematocrit are the only donor-specific characteristics used, a three-tiered nomogram, such as the FDA nomogram described above, can be employed in which three different donor weight classes are utilized (between 110 and 149 pounds, between 150 and 174 pounds, and 175 pounds or greater). For example, under the FDA nomogram, if a donor weighs 180 pounds, 800 mL of plasma and 880 mL of plasma product (plasma and anticoagulant) may be collected. The volume of anticoagulant in the plasma product can be calculated using a default or donor-specific hematocrit.
[0048] Alternatively, the donor's total blood volume can be determined using the donor's weight and height, for example using the Lemens formula, where the total blood volume is based on the donor's BMI (body mass index) (TBV=70 / √(BMI / 22)). The donor's hematocrit is then applied to the donor's total blood volume to determine the total plasma volume (TPV). A certain percentage of the TPV is set as the target volume of plasma to be collected from the donor, and an upper limit is set (e.g., 1000 mL).
[0049] In yet another alternative, the donor's total blood volume can be determined using the donor's weight, height, and sex, for example by using the Nadler equation, and the donor's hematocrit can then be applied as described above to determine the total plasma volume and the target volume of plasma to be collected.
[0050] As will be appreciated, the methods for determining total blood volume described above are exemplary. Other commonly accepted methodologies for determining a donor's total blood volume can also be used, such as any of those described in U.S. Patent No. 2020 / 0147289, which is incorporated herein by reference.
[0051] Once either the target volume of plasma to be collected or the target volume of the plasma product (plasma + anticoagulant) has been determined, the percentage of anticoagulant that will make up the plasma product can be determined by applying the donor hematocrit. For example, the percentage of anticoagulant is equal to 1 / (1+ACR×(1−HCT / 100)).
[0052] Once the volume and / or percentage of anticoagulant collected with the plasma has been calculated, the amount of anticoagulant returned / reinfused to the donor with the enriched cells can be determined based on the efficiency of the blood separator. The efficiency of a separator is defined as the ratio of the liquid portion output from the separator to the liquid portion input to the separator. For example, when separating 100 mL of anticoagulated whole blood with a hematocrit of 40%, 60 mL contains liquid (mainly plasma and anticoagulant) and 40 mL contains cellular material (mainly red blood cells), and 40 mL of liquid is collected after separating the anticoagulated whole blood, the efficiency of the separator is 40 / 60=67%. If the efficiency of the blood separator is 67%, then 67% of the anticoagulant will be retained in the collected plasma and 33% of the anticoagulant will be reinfused to the donor with the enriched cells.
[0053] Separation efficiency is a function of several parameters, with different parameters being relevant depending on the technology. For example, hematocrit has a large effect on the efficiency of the centrifuge. (See, for example, RI Brown, Physics of Continuous Flow Centrifugal Cell Separation, Artificial Organs 13(1):4-20 (1989)). The ratio of anticoagulant also affects separation efficiency, since the higher the ratio of anticoagulant, the lower the hematocrit of the anticoagulated whole blood that is separated, and the lower the hematocrit of the blood, the higher the separation efficiency. In spinning membrane separation technology, the surface area of the membrane has a larger effect than the hematocrit. (See, for example, U.S. Pat. Nos. 8,840,790 and 10,046,278). In general, separation efficiency is predetermined and entered into the control unit by the operator or preprogrammed into the control unit.
[0054] Additionally, the determination of the volume of anticoagulant required may also take into account anticoagulants that are typically introduced into the disposable kit for pretreatment steps, such as performing one or more pre-cycles or other pretreatment steps to prime the apheresis kit, prior to the start of the apheresis procedure. Pretreatment volumes of such anticoagulants may vary depending on the disposable kit. These are typically determined empirically and may be preprogrammed into the system controller or entered by the operator.
[0055] The volume of anticoagulant required may also be increased to a predetermined volume, for example 25 mL to 50 mL, to provide a safety margin so that the anticoagulant container is not emptied prior to completion of the plasma exchange procedure.
[0056] As can be appreciated, many of the steps performed in arriving at the predicted total volume of anticoagulant can be pre-programmed into the control unit of the system and enabled to be executed automatically upon appropriate input of relevant donor-specific characteristics by the operator of the system.
[0057] Once a predicted value of the total volume of anticoagulant required for the procedure is determined, a single container of anticoagulant having at least the predicted total volume is connected to the disposable kit. In practice, the anticoagulant is provided in containers containing 250 mL to 1000 mL of anticoagulant. Thus, the single container of anticoagulant attached to the disposable set contains 250 mL of anticoagulant if the total volume of anticoagulant (VACT) required for the procedure is less than 250 mL, 500 mL of anticoagulant if 250 mL < VACT < 500 mL, 750 mL of anticoagulant if 500 mL < VACT < 750 mL, and 1000 mL of anticoagulant if 750 mL < VACT < 1000 mL. The volume of the anticoagulant container to be attached can be presented to the operator in the form of a recommendation viewable on a display associated with the control unit. Further, VACT can be compared to the inventory of anticoagulant containers, and if VACT is greater than the volume of anticoagulant in stock, the operator may be provided with a further notification so that an additional anticoagulant container can be obtained before starting the procedure.
[0058] The basic steps of the method are illustrated by a flow chart including Figure 6 of the present application. Referring to Figure 6, the method includes a first step (box 90) of determining the total blood volume (TBV) of the donor, a second step (box 91) of determining the volume of plasma (VP) to be collected from the donor based on donor-specific characteristics, a third step (box 92) of determining the volume of anticoagulant (VACP) to be collected with the volume of plasma VP, a fourth step (box 93) of estimating the separation efficiency of the blood separator, a fifth step (box 94) of calculating the volume of anticoagulant (VACR) returned to the donor based on the separation efficiency, a sixth step (box 95) of calculating the total volume of anticoagulant used (VACT), where VACT = VACP + VACR, and a seventh step (box 96) of attaching a single container of anticoagulant containing at least VACT to the fluid flow circuit, where each of the steps illustrated in boxes 90-96 are performed before connecting the donor to the fluid flow circuit. As will be appreciated, once donor specific characteristics are entered into the controller by an operator or a data management system, the controller can automatically execute steps 90-92, 94 and 95 and make recommendations regarding the volume of the container of anticoagulant to be installed in the disposable kit.
[0059] It will be understood that the described embodiments are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including combinations of features individually disclosed or claimed herein. For these reasons, the scope of the claims should not be limited to the above description, but should be as set forth in the following claims.
Claims
1. 1. A method carried out in an automated system for performing plasma exchange using a fluid flow circuit and a blood separator, comprising: a) a controller of the automated system determining a total blood volume (TBV) of a donor; b) the controller determines the volume of plasma (V) to be collected from the donor based on the donor-specific characteristics. Ｐ ) and c) The control unit determines the volume V Ｐ The volume of anticoagulant collected with ＡＣＰ ) and d) the control unit determines the volume of anticoagulant returned to the donor (V ＡＣＲ ) and e) the control unit determines the total volume of anticoagulant used (V ＡＣＴ ) and f) at least V in total ＡＣＴ Providing one or more containers of anticoagulant for attachment to the fluid flow circuit, comprising at least V ＡＣＴ and attaching to the fluid flow circuit a single container of anticoagulant comprising g) A method wherein steps a) through g) are performed prior to connecting the donor to the fluid flow circuit.
2. The method of claim 1 , wherein the donor-specific characteristics include weight and hematocrit.
3. The method of claim 2 , wherein the hematocrit is a default value.
4. The method of claim 3 , wherein the default value of hematocrit represents a worst case scenario.
5. The method of claim 4 , wherein the default hematocrit value is 54%.
6. The method of claim 2 , wherein the donor's hematocrit is measured.
7. The method of claim 1 , wherein the donor-specific variables include weight, height, and hematocrit.
8. The method of claim 1 , wherein the donor-specific variables include weight, height, sex, and hematocrit.
9. One or more containers or a single container may contain V ＡＣＴ If < 250 mL, 250 mL of anticoagulant, 250 mL < V ＡＣＴ If <500mL, 500mL of anticoagulant, 500mL <V ＡＣＴ If < 750 mL, 750 mL of anticoagulant, 750 mL < V ＡＣＴ 2. The method of claim 1, comprising 1000 mL of anticoagulant for <1000 mL.
10. V ＡＣＰ = V Ｐ 2. The method of claim 1, wherein ACR is the anticoagulant to whole blood ratio and Hct is the donor's hematocrit.
11. The method of claim 1 , wherein the separation efficiency of the blood separator is determined at least in part based on the hematocrit of the donor.
12. 10. The method of claim 1, wherein the separation efficiency of the blood separator is based, at least in part, on the anticoagulant-to-whole blood ratio (ACR) used.
13. V ＡＣＴ = V ＡＣＰ +V ＡＣＲ The method of claim 1, wherein
14. V ＡＣＴ is the volume of plasma to be collected V Ｐ and an estimated volume of whole blood to be processed to reach a separation efficiency.
15. V ＡＣＴ 10. The method of claim 1, further comprising a volume of anticoagulant used to prime the fluid flow circuit and the blood separator.
16. V to provide a safety margin ＡＣＴ The method of claim 1 , wherein is increased.
17. V to provide a safety margin ＡＣＴ The method of claim 15, wherein is increased.
18. V ＡＣＴ The method of claim 17, wherein the amount of the solution is increased by 25 mL to 50 mL.
19. The control unit of the automation system is V ＡＣＴ comparing the anticoagulant to an inventory of anticoagulant containers; ＡＣＴ and determining whether is greater than the volume of anticoagulant in the inventory.
20. 1. An automated system for separating plasma from whole blood comprising a disposable fluid flow circuit including a separator for separating whole blood into a plasma fraction and an enriched cell fraction, and reusable hardware components including a programmable controller having a touch screen for receiving input from an operator, the automated system being configured to provide a calculation of a total volume of anticoagulant required for treatment based on the operator's input.
21. The programmable control unit includes: The total blood volume (TBV) of the donor and the volume of plasma (V) that will be collected from the donor based on the donor's unique characteristics Ｐ ) and the plasma volume V Ｐ The volume of anticoagulant collected with ＡＣＰ ) and the volume of anticoagulant returned to the donor (V ＡＣＲ ) and the total volume of anticoagulant used (V ＡＣＴ ) and apply V ＡＣＴ 21. The automated system of claim 20, configured to display:
22. The control unit is V ＡＣＴ and further configured to make a recommendation regarding a total volume of anticoagulant to be installed in the disposable fluid flow circuit based on V ＡＣＴ If < 250 mL, 250 mL of anticoagulant, 250 mL < V ＡＣＴ If <500mL, 500mL of anticoagulant, 500mL <V ＡＣＴ If < 750 mL, 750 mL of anticoagulant, 750 mL < V ＡＣＴ 20. The automated system of claim 19, wherein for volumes <1000 mL, it is recommended to provide a single container or multiple containers containing 1000 mL of anticoagulant.