Systems and methods for optimizing plasma collection volume

Abstract

The present invention relates to systems and methods for optimizing plasma collection volume. A plasma withdrawal system and a method for operating a plasma withdrawal system are provided by which the volume / weight of the anticoagulated plasma collected is optimized. In one example, a nomogram is provided that utilizes the donor hematocrit to calculate the volume / weight of raw plasma within a plasma product having a maximum volume allowed by the FDA nomogram. In a plasma withdrawal process having multiple collection phases followed by a reinfusion cycle in which concentrated red blood cells are returned to the donor, the volume of plasma product to be collected is calculated prior to the start of each collection cycle to account for the increasing hematocrit of the donor, resulting in a greater total volume of plasma product to be collected during the plasma withdrawal process.

Description

[0001] This application is a divisional application of the invention patent application filed on May 21, 2019, with application number 201980031598.1 (PCT / US2019 / 033318) and entitled "System and method for optimizing plasma collection volume". Technical Field

[0002] This application relates to systems and methods for performing plasma pheresis, and more specifically to plasma pheresis systems and methods in which the volume of source plasma or raw plasma products capable of being collected from a particular donor is optimized. Background Technology

[0003] Plasma extraction is an apheresis procedure in which whole blood is drawn from a donor, the plasma is separated from the cellular blood components (red blood cells, platelets, and white blood cells) and retained, and then the cellular blood components are returned to the donor. The separation of plasma from cellular components is usually accomplished automatically by centrifugation or diaphragm filtration.

[0004] In automated plasma retrieval, whole blood is aspirated from the donor, mixed with an anticoagulant (“AC”) at a specific ratio, and then separated into anticoagulated plasma and red blood cells and other cellular components. Once the target volume of anticoagulated plasma (or “plasma product”) has been collected, as determined by a weighing scale associated with the plasma collection container, whole blood aspiration from the donor is stopped, and the red blood cells and other cellular components are returned to the donor. Typically, plasma product is collected in multiple collection and retransfusion cycles until the total target volume of anticoagulated plasma has been collected. This anticoagulated plasma is used for subsequent transfusions or further production.

[0005] Plasma collected for use as source material in further production (“source plasma”) is collected from multiple donors and combined or merged together for this purpose. The FDA has issued guidance for registered blood collection centers regarding the volume of plasma that can be collected as source plasma during plasma collection to improve consistency in the process used to produce source plasma and minimize the chance of human error. (FDA guidance: “Volume Limits – Automated Collection of Source Plasma (11 / 4 / 92)”). This FDA guidance addresses inconsistencies caused by the various types of anticoagulant solutions used, different concentrations of anticoagulants, and different ranges of anticoagulant-to-plasma ratios.

[0006] The FDA regulation provides a simplified plasma volume nomogram, which is reproduced in... Figure 1The chart shown restricts the volume (or weight) of plasma that can be collected from a specific donor to ensure donor safety and comfort. More specifically, the FDA nomograph limits plasma volume (or weight) based on donor weight and establishes the volume of anticoagulant, which can be added at a ratio of 1:16 anticoagulant to 1 part anticoagulant blood or at a ratio of 0.06 parts anticoagulant to 1 part anticoagulant blood to achieve the maximum collection volume as a sum of plasma and anticoagulant for a specific donor.

[0007] The simplified nomogram provided in FDA regulations is the primary method for determining the collection volume of plasma products used in blood collection centers. Therefore, plasma collection equipment used in such centers is typically programmed to collect a specific volume / weight of anticoagulated plasma (assuming known density) according to the maximum collection volume allowed by the FDA nomogram, where the anticoagulant is added to whole blood at a ratio of 1:16 or 0.06.

[0008] One simplification of the FDA nomogram is that it disregards donor hematocrit when determining the collection volume of plasma products. However, the relative ratio of raw plasma to anticoagulant in a plasma product depends on the donor's hematocrit and the ratio of AC to the donor's whole blood. As a result, donors with higher hematocrits reach the maximum collection volume given in the FDA nomogram before reaching the maximum (raw) plasma volume that can be safely collected from that donor. This leads to inefficiencies in plasma collection centers because the volume of raw plasma collected is smaller than the maximum possible.

[0009] In addition, the amount of plasma that can be safely collected from a donor may also depend on factors other than the donor's weight and hematocrit, such as the donor's height, sex, and age, as these factors affect the donor's total blood volume (and plasma volume).

[0010] Since source plasma from multiple donors is combined, maximizing the volume of plasma collected from each individual donor is crucial, as even a small increase in the volume collected from each individual donor can lead to a significant increase in the total volume of combined plasma when added together. If the plasma extraction device can be better targeted for the volume of raw plasma, more plasma proteins can be collected from each donor, thereby improving the overall efficiency of the plasma collection center. Therefore, this disclosure provides a system and method for optimizing the volume of collected plasma in accordance with donor safety and comfort. Summary of the Invention

[0011] This disclosure provides a method for operating a plasma extraction system to collect a volume of anticoagulated plasma (i.e., plasma product) that ensures the total volume of raw plasma in the plasma product is a maximum value consistent with the safety and comfort of the donor, whether indicated by the donor's unique physical characteristics, an FDA nomogram, or some other method, that can be collected from a particular donor.

[0012] According to a first aspect of this disclosure, a method is provided for operating a plasma extraction system to collect a plasma product volume, the plasma product volume including the maximum permissible volume / weight of raw plasma as limited by the donor weight according to the limits given in the FDA nomograph.

[0013] To collect the maximum volume / weight of raw plasma allowed by the FDA nomogram, a modified nomogram is provided that uses the donor's hematocrit to calculate the target volume / weight of the plasma product having the maximum volume of raw plasma allowed by the FDA nomogram. The calculated volume / weight of the raw plasma is compared to the maximum volume / weight of raw plasma allowed by the FDA nomogram. If the calculated volume / weight of the raw plasma is less than the maximum allowed volume / weight, the volume / weight of the plasma product to be collected is increased from the maximum volume / weight allowed by the FDA nomogram for that plasma product by an amount equal to the difference plus the additional amount of anticoagulant added to process the extra volume / weight of plasma.

[0014] Therefore, given the donor's hematocrit and the instrument's AC ratio, the volume of additional raw plasma that can be safely collected from the donor, consistent with the limits given in the FDA nomograph, is determined, and then the total volume / weight of the plasma product to be collected is adjusted accordingly based on the donor's weight given in the FDA nomograph.

[0015] Typically, the plasma extraction process involves a continuous cycle of alternating phases. One of these phases involves drawing whole blood from the donor, separating and collecting the plasma, while another phase involves returning the separated red blood cells and any other non-RBC cell components to the donor. The donor's hematocrit will change during plasma extraction, thus affecting the amount of anticoagulant in the collected plasma product from one cycle to the next.

[0016] Therefore, in the first aspect of this disclosure, a new hematocrit value for the donor is determined before the start of the subsequent extraction / separation phase, and the target volume / weight of the plasma product for the process is recalculated before the start of each extraction / separation phase to ensure that the maximum amount of raw plasma permitted by FDA Normograph is collected.

[0017] According to the second aspect, another method is provided for collecting a certain amount of plasma during apheresis. The steps of this method include: determining the donor's total whole blood volume V. b Based on V b Determine the volume V of raw plasma that can be collected from the donor. RP The target volume V of the plasma product to be collected is determined based on the anticoagulant ratio (ACR, defined as the ratio of donor blood volume to anticoagulant volume for donor blood without anticoagulant) established for this process and the donor's Hct. PP , where V PP Equal to the volume V of the raw blood plasma to be collected RP Add to V during the single-collection process RP Anticoagulant V AC The volume of V makes V PP =V RP *K, where K = (ACR * (1 - Hct / 100) + 1) / (ACR * (1 - Hct / 100)); whole blood is drawn from the donor; an anticoagulant is added to the whole blood in an amount consistent with ACR; plasma products are separated from the whole blood; and the plasma products are transferred to a collection container until the volume of plasma products in the collection container reaches V. PP Until then. Because the plasma retrieval process involves multiple extraction / separation and return phases, the Va for the process will be recalculated before the start of each extraction / separation phase, based on the donor's hematocrit value determined before the start of each extraction phase. PP And adjust the target volume of the plasma product accordingly. Alternatively, it can be based on a calculated value of the donor's total plasma volume—this calculation is based on V... b Calculated from the donor's hematocrit – determining V RP .

[0018] In a third aspect, a method for determining the volume V of plasma product that can be collected during apheresis is provided. PP The method, in which V PP Equal to the volume V of raw plasma that can be collected RP Add to V during the single-collection process RP The volume V of the anticoagulant AC The steps of this method include: determining the donor's weight W. kg And sex M or F; determine the donor's hematocrit Hct; based on the donor's weight W kg The volume V of raw plasma that can be collected is determined by gender M or F. RP V was determined based on the anticoagulant ratio (ACR) and the donor's Hct. PP With V RP The ratio K between them makes K = V PP / VRP Determine V PP This makes V PP =V RP *K. Furthermore, K = (ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)). In V PP Once determined, whole blood is drawn from the donor; anticoagulant is added to the whole blood at the amount consistent with the ACR; plasma products are separated from the whole blood; and the plasma products are transferred to the collection container. After the desired amount of whole blood has been drawn from the donor, red blood cells are returned to the donor. Then, the donor's Hct and V are determined before each aspiration stage. PP .

[0019] In the relevant aspects, the aspiration and separation steps are repeated until the volume of plasma product in the collection container reaches V. PP until.

[0020] In this regard, the donor's hematocrit after the first collection phase can be calculated using volume balance, assuming that the number of red blood cells in the donor is the same at the beginning of each aspiration cycle, while the total blood volume decreases from one cycle to the next in an amount equal to the amount of raw plasma collected. Alternatively, the donor's hematocrit at the beginning of each aspiration cycle can be measured using an optical sensor or other sensors.

[0021] On the other hand, the volume of raw plasma collected from a specific donor can be determined using any of several different methods. These methods include, for example, the FDA nomograph, which only considers the donor's weight; and a modified FDA nomograph, which further considers the donor's hematocrit and a portion of the total blood volume or total plasma volume calculated for a specific donor. The total blood volume or total plasma volume can be determined, for example, using the Nadler equation, the Gilcher five-point system, tables provided by the International Council for Standardization of Hematology (ICSH), or any other generally accepted method that takes into account the donor's height, weight, sex, and age in a manner consistent with the donor's safety and comfort.

[0022] In a fourth aspect, an automated system for separating plasma from whole blood is provided, the automated system comprising reusable hardware components and a disposable kit. The disposable kit further includes: i) a separator for separating whole blood into a plasma fraction and a concentrated cell fraction, the separator having an input end, a plasma output port, and a concentrated cell outlet port, the input end having a blood line integrally connected to the input end for transferring whole blood from a donor to the separator, the plasma output port being integrally connected via the plasma line to a plasma collection container, and the concentrated cell outlet port being integrally connected to a reservoir for receiving concentrated cells prior to re-infusion to a donor; ii) a donor line terminating at a venous puncture needle for transferring whole blood from a donor to the blood line; iii) an anticoagulant line integrally connected to the blood line and configured to connect to an anticoagulant source for transferring anticoagulant to the donor line; and iv) a re-infusion line for transferring concentrated cells from the reservoir to the donor line.

[0023] The reusable hardware components also include: i) a peristaltic first pump for delivering anticoagulant at a controlled rate into the blood line during the collection phase; ii) a second pump for delivering anticoagulant whole blood to a separator during the collection phase and returning concentrated cell fractions during the reinfusion phase; iii) a third pump for delivering concentrated cell fractions from the separator to a reservoir during the collection phase; iv) a clamp associated with each of the blood line, plasma line, and reinfusion line; v) a weighing scale for weighing each of the anticoagulant sources in the plasma collection container and reservoir; and vi) a programmable controller including a touchscreen for receiving input from the operator, the programmable controller being configured to receive signals from each of the weighing scales and automatically operate the first, second, and third pumps and the clamp to separate whole blood into plasma and concentrated cell fractions during the collection phase and to return concentrated cells to the donor during the reinfusion phase. The programmable controller is also configured to determine a target amount of plasma product to be collected in the plasma collection container according to any of the methods described herein, and the programmable controller is configured to terminate the collection phase upon receiving a signal that the amount of plasma product in the plasma collection container is equal to the target amount of plasma product determined by the controller. In determining the target amount of plasma product to be collected, the controller may be configured to calculate the donor's hematocrit before each collection phase of a cycle. Alternatively or additionally, the controller may receive a signal from a sensor or the like indicating the donor's hematocrit. Furthermore, the amount of plasma product in the plasma collection container may be determined, for example, by a weighing scale associated with the plasma collection container or by an optical sensor that directly measures volume. Attached Figure Description

[0024] Figure 1 This is a table showing the simplified nomogram proposed in the FDA's "Volume Limitations - Automated Collection of Source Plasma (11 / 4 / 92)".

[0025] Figure 2 This is a perspective view of an exemplary plasma extraction instrument applicable to the systems and methods of this application.

[0026] Figure 3 It is able to Figure 2 A portion of a rotating diaphragm separator, a type of device used in conjunction with a disposable kit and used with plasma extraction systems, is cut open to show a detailed perspective view.

[0027] Figure 4 yes Figure 2 A perspective view of the front panel of a plasma extraction system, showing the components of a disposable kit mounted to the front panel.

[0028] Figure 5 This is a schematic diagram illustrating the operation of the plasma extraction system during the collection phase.

[0029] Figure 6 This is a schematic diagram illustrating the operation of the plasma extraction system during the reinfusion phase.

[0030] Figure 7 It is a table showing the volume of raw plasma based on donor hematocrit, which is contained within the plasma product volume limits set by the FDA Normograph, using an anticoagulant to whole blood ratio of 16:1.

[0031] Figure 8 It shows that based on Figure 7 The table lists the difference between the values ​​listed and the maximum volume of raw plasma that can be collected based on the FDA nomograph for the volume of "unclaimed" raw plasma in the plasma product.

[0032] Figure 9 This is a table showing the volume of plasma product that, based on the donor's weight and hematocrit, will result in the maximum permissible volume of raw plasma allowed by the FDA Normograph.

[0033] Figure 10 This is a table showing the inputs to a programmable controller used to perform a hypothetical plasma extraction process, according to this application.

[0034] Figure 11a , Figure 11b Includes a table divided into two parts, illustrating how to base it on... Figure 10The input in the table increases the donor's hematocrit during the hypothetical plasma extraction process, leading to an increase in the total volume of plasma product required to collect the target volume of plasma raw material.

[0035] Figure 12 This is a diagram illustrating the dilution of IgG during plasma extraction. Detailed Implementation

[0036] A more detailed description of the systems and methods according to this disclosure will now be set forth. It should be understood that the following description of particular devices and methods is intended to be exemplary and not to exhaustively cover all possible variations or applications. Therefore, the scope of this disclosure is not intended to be limiting and should be understood to cover variations or implementations that would occur to those skilled in the art.

[0037] In the context of this application, plasma extraction is performed on an automated system comprising hardware components generally designated as 10 and disposable kits generally designated as 12, to collect plasma to be processed as source plasma. (See also...) Figures 2 to 6 As described in more detail below, the disposable kit 12 consists of an integrally connected separator, container, and tubing for transporting blood and solutions within a sterile fluid path.

[0038] exist Figure 3 The separator 14, best illustrated, has a rotating diaphragm filter 16 mounted to a rotor 18 for rotation within a housing 20 to separate blood into individual components. A detailed description of the rotating diaphragm separator can be found in U.S. Patent No. 5,194,145 to Schoendorfer, which is incorporated herein by reference. As will be understood, in different systems, the separation of whole blood can be accomplished by centrifugation. See, for example, US 5,360,542 to Williamson et al.

[0039] During plasma extraction, anticoagulated whole blood is passed through whole blood inlet port 22 into separator 14. Plasma is separated by a rotating diaphragm filter and then flows out from plasma outlet port 24, through plasma line 26, and into plasma collection container 28. Concentrated cells are pumped from concentrated cell outlet port 30 into reservoir 32, where the cells remain until they are re-infused to the donor.

[0040] The disposable kit 12 also includes the following lines: a line for introducing whole blood from the donor into the system during collection and returning concentrated cells to the donor during re-infusion (donor line 34, which terminates in a venous puncture needle 36); a line for delivering anticoagulated whole blood to a separator (blood line 38); a line for delivering concentrated cells to a reservoir (cell line 40); a line for delivering concentrated cells from the reservoir to the donor line (re-infusion line 42); a line for delivering plasma to a plasma collection container (plasma line 44); a line for saline (saline line 46); and a line for anticoagulant (AC line 48).

[0041] Hardware component 10 includes a programmable controller 50 and a touchscreen 52 with a graphical user interface (“GUI”) through which the operator controls the plasma retrieval process. For example, the GUI allows input 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 regimen is selected) and target plasma volume. The touchscreen 52 also enables the operator to collect status information and handle error conditions.

[0042] Three peristaltic pumps are positioned on the front panel of hardware component 10, including an AC pump 54, a blood pump 56, and a cell pump 58. When whole blood enters the kit from the donor, AC pump 54 delivers an anticoagulant solution (AC) to blood line 38 at a controlled rate. Blood pump 56 delivers anticoagulant whole blood to a separator during the collection phase of the plasma extraction process and returns concentrated cellular components to the donor during the re-infusion phase of the plasma extraction process, and returns replacement fluid to the donor if necessary. Cell pump 58 delivers concentrated cellular components from separator 14 to a reservoir during the collection phase.

[0043] The front panel also includes four clamps into which the disposable kit 12 is installed. These four clamps include a reinfusion clamp 60, a blood clamp 62, a saline clamp 64, and a plasma clamp 66. The reinfusion clamp 60 is used during the collection phase ( Figure 5 ) Close to block the reinfusion line (42), and during the reinfusion phase ( Figure 6The blood clamp 62 opens during the collection phase to allow the blood pump to re-infuse concentrated cellular components from reservoir 32 to the donor. The blood clamp 62 opens during the collection phase to allow anticoagulated whole blood to be pumped to separator 14 and closes during the re-infusion phase to block the blood line 38. The saline clamp 64 closes during the collection phase and during the re-infusion of the separated cellular components to block the saline line 46. If saline is used as an alternative fluid, the saline clamp 64 opens during the re-infusion phase. The plasma clamp 66 opens during the collection phase to allow plasma to flow into plasma collection container 28 and closes during the re-infusion phase.

[0044] Hardware component 10 includes three scales to monitor the current plasma collection volume (scale 68), AC solution volume (scale 70), and concentrated cell component volume (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.

[0045] The donor remains connected to the system throughout the process. As illustrated, the disposable kit 12 includes a single intravenous puncture needle 36, used during the collection phase ( Figure 5 Whole blood is drawn from the donor through the venous puncture needle 36, and during the re-infusion phase ( Figure 6 The concentrated cells are returned to the donor via the venipuncture needle 36. As mentioned above, the plasma retrieval process may include multiple cycles, each with a collection / separation phase followed by a return or reinfusion phase. During the collection phase, whole blood is separated into plasma and concentrated cells. The disposable kit includes a plasma collection container 28 for receiving the separated plasma and a reservoir 32 for receiving the concentrated cells. During the reinfusion phase, the concentrated cells from the reservoir 32 are reinfused to the donor via the venipuncture needle 36. Typically, plasma retrieval using a single venipuncture needle 36 involves multiple collection and reinfusion cycles.

[0046] Return to Figure 5 During the collection phase, an anticoagulant solution (AC) is pumped at a controlled rate and mixed with whole blood as it enters disposable kit 12. The anticoagulant blood is pumped to separator 14, where plasma is separated from cellular components and directed to plasma collection container 28.

[0047] Cellular components are pumped from separator 14 to reservoir 32. The collection phase stops when reservoir 32 reaches the desired volume of concentrated cells or if the target plasma collection volume has been reached.

[0048] Then, the infusion phase begins. (Refer to...) Figure 6During the reinfusion phase, the blood pump 56 reverses direction and pumps concentrated cells from the reservoir 32 back to the donor via the apheresis needle 36. If the saline protocol is selected, saline is returned to the donor as a replacement fluid for the collected plasma, and saline infusion is performed after the final reinfusion phase.

[0049] According to one aspect of this disclosure, an automated plasma collection device is configured to collect a volume / weight of anticoagulated plasma (i.e., plasma product) having the maximum volume / weight of raw plasma allowed by the donor under the limits given in the FDA nomograph. To maximize the volume of raw plasma containing the plasma product, the device is programmed using a nomograph that takes into account the donor's hematocrit. Given the donor's hematocrit and the instrument's AC ratio, the total volume / weight of the plasma product to be collected can be determined such that the plasma product includes the maximum volume / weight of raw plasma material that can be collected from the donor, consistent with the limits on the total volume / weight of raw plasma given in the FDA nomograph. By programming the calculation into the controller, the possibility of operator error is reduced compared to calculating the collection volume offline and then inputting that volume into the instrument.

[0050] During plasma extraction, when the anticoagulant is mixed with whole blood drawn from the donor, the anticoagulant is uniformly distributed in the raw plasma within the blood. However, the amount of raw plasma in the whole blood depends on the hematocrit (Hct) of the whole blood. The following relationship was established:

[0051] RBC volume = whole blood volume * Hct / 100. [1]

[0052] The volume of raw plasma = the volume of whole blood * (1 - Hct / 100). [2]

[0053] When mixing anticoagulants with whole blood, the AC ratio (ACR) is usually measured as 16 parts whole blood to 1 part AC or 1 part whole blood to 0.06 parts AC.

[0054] ACR = Volume of whole blood / Volume of anticoagulant (donor blood contains no anticoagulant). [3]

[0055] (This yielded slightly different results from the FDA nomograph, which, as mentioned above, normalizes the volume of anticoagulant that can be added to a ratio of 1:16 between anticoagulant and anticoagulated blood, or 0.06 parts anticoagulant to 1 part anticoagulated blood.)

[0056] The volume of anticoagulated blood = the volume of anticoagulant + the volume of whole blood. [4]

[0057] Combining the equation, we can derive:

[0058] The volume of raw plasma = ACR * anticoagulant volume * (1 - Hct / 100). [5]

[0059] Because the red blood cells were returned to the donor:

[0060] The volume of plasma collected = the volume of raw plasma + the volume of anticoagulant. [6]

[0061] Equations [5] and [6] can be combined to calculate the amount of anticoagulant in a given volume of collected plasma: Volume of anticoagulant = Volume of collected plasma / (1 + ACR * (1 - Hct / 100)). [7]

[0062] also:

[0063] The volume of collected plasma = the volume of raw plasma * K, where K = (ACR * (1 - Hct / 100) + 1) / (ACR * (1 - Hct / 100)). [8]

[0064] Considering the relationships expressed in the above equations, the volume of raw plasma contained in a plasma product, within the allowable volume according to the FDA nomograph, can be determined based on the donor's hematocrit. The results of this calculation are... Figure 7 The text is incomplete and contains errors. A more accurate translation would require the full context. Figure 7 The figure shows the volume of raw plasma contained within the plasma product volume limits set by the FDA Normograph, based on donor hematocrit.

[0065] For reference Figure 7 Understandably, for donors weighing between 110 and 149 pounds (for which the maximum plasma volume according to the FDA nomograph is 690 mL), if the donor's hematocrit is 42 or greater, the volume of raw plasma collected will be less than the 625 mL allowed by the FDA nomograph. A similar situation applies to donors weighing between 150 and 174 pounds (for which the maximum plasma collection volume according to the FDA nomograph is 825 mL) and to donors weighing over 175 pounds (for which the maximum plasma collection volume according to the FDA nomograph is 880 mL), when the donor's hematocrit is 40 or greater.

[0066] Figure 8 The table given is based on Figure 7 The difference between the value given and the maximum volume of raw plasma that can be collected based on the FDA nomograph represents the volume of "unrequired" raw plasma in the plasma product. Therefore, as... Figure 9 As shown in the table provided, plasma products collected from any particular donor can be adjusted according to the plasma products given in the FDA nomograph as follows: This amount is consistent with... Figure 8The amount of "unrequired" raw plasma given in the text corresponds to the amount of anticoagulant required to process the additional volume.

[0067] Alternatively, the volume of the plasma product to be collected can be calculated using the following steps: First, determine the donor's weight and hematocrit Hct; based on the donor's weight W... kg Determine the raw material plasma V that can be collected RP The volume; determined based on the anticoagulant ratio (ACR; 1:16 or 0.06:1 according to the FDA nomograph) and the donor's Hct. PP With V RP The ratio K between them makes K = V PP / V RP ; and determine V PP This makes V PP =V RP *K. In addition, K = (ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)).

[0068] In another alternative, the volume V of the plasma product to be collected can be calculated using the following steps. PP First, determine the donor's weight W. kg Hematocrit (Hct); based on donor weight (W) kg Determine the raw material plasma V that can be collected RP The volume of anticoagulant to be added (V) is determined based on the anticoagulant ratio (ACR; 1:16 or 0.06:1 according to the FDA nomograph) and the donor's hematocrit. AC This makes V AC =V RP *(ACR*(1-Hct / 100)); and determine the acquisition volume such that V PP =V RP +V AC .

[0069] Various methods can be used to determine the volume of raw plasma that can be collected based on the donor's weight. For example, the donor's weight can be multiplied by an established constant "K1" (e.g., 10 mL / kg). Alternatively, donor weights can be categorized into weight classes, with a fixed volume established for each class (as discussed above in the FDA nomograph, where the range of donor weights is divided into three classes).

[0070] Alternatively, the donor's plasma volume can be estimated based on the donor's total blood volume, and this estimate can be used to obtain a plasma volume consistent with the donor's safety and comfort. Methods utilizing donor parameters are commonly used to estimate the donor's total blood volume. Examples of these methods include Nadler's equation (which considers the donor's height, sex, and weight), Gilcher's five-point system (which considers sex, weight, and body type (obese, lean, normal, or robust), or the standards of the International Committee for Standardization of Hematology (“ICSH”) as given in Br. J. Haem. 1995, 89:748-56 (which considers the donor's height, weight, age, and sex). Any other generally accepted method can also be used to determine the donor's total blood volume. Once the donor's total blood volume is determined, the donor's plasma volume can be estimated by multiplying the total blood volume by a constant “K2”, where “K2” equals (1 - donor's Hct).

[0071] An analysis of demographic, examination, and laboratory data from the 2015-2016 National Health and Nutrition Examination Survey—in which sex, age, height, weight, pregnancy data, and hematocrit were extracted and presented in Pearson et al.’s Interpretation of measured red cell mass and plasma volume in adults: Expert Panel on Radionuclides of the International Council for Standardization in Haematology (1995) (based on the analysis of the ICSH-recommended formula)—has determined that up to 36% of usable plasma can be collected from donors with certain characteristics (i.e., low-weight women with high hematocrit) while complying with current regulations. Plasma collection procedures from such donors have been routinely performed without adverse effects and are therefore considered safe. This indicates that up to 36% of the donor's usable plasma can be safely collected during the plasma extraction process.

[0072] Considering the potential risks associated with only a negative deviation between the donor's actual blood volume and the predicted / calculated total blood volume, it would be appropriate to further reduce the available plasma volume. Based on the discrepancy between the calculated blood volume determined by Pearson et al. (cited above) and the experimental blood volume data presented in Retzlaff et al.'s study, *Erythrocyte Volume, Plasma Volume, and Lean Body Mass in Adult Men and Women* (J. Haematology, 33, 5:649-667 (1969)), there is a 95% confidence that the individual's predicted blood volume will differ by no more than 20.5%. Therefore, a proportionality factor of 0.795 can be used to determine the available raw plasma, representing 36% of the donor's total plasma volume as described above, so that 28.6% of the donor's calculated raw plasma volume can be obtained in accordance with donor safety and comfort.

[0073] Alternatively, the volume V of available plasma can be calculated. RP The previously calculated volume V of whole blood WB Adjust V C Thus, V RP =0.36(1-Hct)(V WB -V C Regression analysis was performed on the data provided by Retzlaff, and the results determined V. C =523mL.

[0074] Therefore, the collection volume (volume of plasma product) is determined based on the volume of raw plasma that can be collected from a specific donor, the donor's hematocrit, and a fixed anticoagulant ratio (ACR). This method allows for more consistent control over the donor's raw plasma volume, which is the variable most relevant to donor safety.

[0075] In practice, the operator inputs the target volume of plasma product for a specific donor into the system controller based on the available raw plasma volume. The target plasma collection volume can be based on the donor's weight and hematocrit at the initial collection stage, or determined by any of the other methods given above. Figure 9As given in [reference needed]. Alternatively, the controller is configured to: for the initial collection phase, when the operator inputs the target plasma product collection volume, such as the donor's weight and hematocrit and / or any other donor-specific information (e.g., donor's sex, height, and age), as required by the methods used to determine the donor's total blood volume, total plasma volume, and the target volume of available plasma that can be collected, calculate the target plasma product collection volume according to methods such as those described above. In another alternative, the plasma collection device can be integrated with a donor management system, through which donor parameters for eligibility screening (e.g., weight, hematocrit, etc.) can be electronically transmitted to the instrument, eliminating the chance of operator error in inputting donor parameters. The donor management system can also automatically calculate the plasma collection volume using donor screening measurements and the relationship between raw plasma volume and collection volume, which is then transmitted to the controller of the plasma extraction device.

[0076] As mentioned above, the plasma retrieval process is performed in multiple cycles of collection / aspiration and return / reinfusion phases. If the return / reinfusion phase does not include the reinfusion of replacement fluids, the donor's hematocrit will increase from one cycle to the next. Therefore, if the target volume of the plasma product is determined solely based on the donor's initial hematocrit without considering the increase in the donor's hematocrit, the volume of anticoagulant in the plasma product will be larger than predicted by the initial calculations used to determine the target volume of the plasma product (while the volume of raw plasma will be smaller). Therefore, to ensure that the volume of the collected plasma product includes the maximum volume of raw plasma determined to be obtained from a particular donor, the target volume of the plasma product is recalculated periodically throughout the plasma retrieval process, such as before the start of the collection phase of each cycle, to take into account changes in the donor's hematocrit.

[0077] Therefore, the target volume of the plasma product is determined based on the donor's initial hematocrit. The plasma extraction process begins with the first aspiration phase and continues until a specified volume of whole blood (typically approximately 500 mL) has been extracted from the donor. An anticoagulant is added to the whole blood, and the anticoagulated whole blood is separated into plasma product, red blood cells, and other non-RBC blood components. At the end of the first aspiration phase, the red blood cells and non-RBC blood components are returned to the donor. The current volume of the plasma product collected after the first aspiration phase is determined, for example, by a weighing scale. The donor's current hematocrit value is then established, and a new target volume of plasma product to be collected is determined, and a second cycle of the aspiration and return phases is performed. The cycle of aspiration and return phases is repeated until the target volume of plasma product for this plasma extraction process, as recalculated before the start of each aspiration phase, is collected. After the final collection phase, the controller initiates the final red blood cell re-infusion phase, after which the donor is disconnected.

[0078] Reference Figure 10 and Figure 11a , Figure 11b The table shows the benefits of performing a plasma extraction process with multiple collection / reinfusion cycles according to the method given above. Figure 10 The input data for a hypothetical plasma extraction procedure is shown for a donor weighing 190 lbs (86.4 kg) with an initial hematocrit of 44. Reference Figure 1 The simplified FDA nomogram limits the volume of plasma to be collected from such donors to 800 mL and the total volume of plasma product to be collected to 880 mL. In this example, the FDA nomogram's limitations on the volume of raw plasma that can be collected are for illustrative purposes only. As given above, other methods can be used to determine the amount of raw plasma that can be safely drawn from a donor, which may differ from the amount indicated by the FDA nomogram.

[0079] The number of collection and re-infusion cycles in a plasma retrieval process can range from three to twelve. In the hypothetical plasma retrieval process, there are five collection and re-infusion cycles; the choice of five collection and re-infusion cycles is for illustrative purposes.

[0080] Before the start of the first collection cycle, the volume of raw plasma to be collected and the total target volume of the plasma product to be collected are determined based on the donor's initial hematocrit according to the method described above. As given in the first row of the table (start of cycle 1), the initial target volume of the plasma product to be collected is 889 mL, which is consistent with the initial target volume of the plasma product to be collected. Figure 9 The form is the same as that for donors weighing over 175 pounds and with a hematocrit of 44, in order to obtain 800 mL of raw plasma from the donor, which is FDA-restricted.

[0081] During each collection phase, 500 mL of whole blood was drawn from the donor, and anticoagulant was added to the whole blood at a predetermined ratio (i.e., 1:16), such that 31 mL was added for each 500 mL collection cycle. The whole blood with anticoagulant was then separated into plasma and red blood cell fractions.

[0082] During the first return phase (end of cycle 1 return), red blood cells and “non-RBC” blood components are returned to the donor, increasing the donor’s hematocrit to 45.6% at the end of the first return cycle. This is calculated by the controller based on the fact that the blood volume is reduced by the amount of raw plasma collected, while the number of red blood cells in the total blood volume remains the same as at the start of the plasma extraction process. When determining the new hematocrit value for the next cycle, the controller may also consider the volume of anticoagulant re-infused with red blood cells in each return phase and the residual anticoagulant in the donor whole blood aspirated in cycle 2 and thereafter. The raw plasma volume to be collected and the total target volume of plasma products for this process are then recalculated based on the donor’s raw plasma volume and the newly increased hematocrit. This provides a new target collection volume of 891 mL.

[0083] The second collection phase was then performed, resulting in a total of 430 mL of plasma product containing 386 mL of raw plasma collected during the first two collection phases (end of cycle 2 aspiration). Red blood cells and “non-RBC” blood components were returned to the donor, after which the donor’s hematocrit was calculated to be 47.2%.

[0084] Two more 500mL collection phases are performed, each followed by a return phase, where new values ​​for the volume of raw plasma to be collected and the total volume of plasma product are determined before the start of each collection phase. As the donor's hematocrit increases, the target collection volume for this process is recalculated to 893mL (for the third collection phase), and then to 894mL (for the fourth collection phase). A fifth "micro" collection cycle is performed to bring the collected raw plasma volume to 800mL, as per the FDA nomograph for the assumed donor. The recalculated target collection volume of plasma product for the fifth collection phase remains at 894mL.

[0085] Therefore, as shown in the example above, when the target collection volume for the plasma product is recalculated for each collection stage, the target collection volume for the plasma product is 894 mL, which is required to collect the target volume of 800 mL of raw plasma. In contrast, if the target collection volume is determined solely based on the donor's initial hematocrit, 889 mL of plasma product will be collected; or, if the target collection volume is based on a simplified FDA nomogram, 880 mL of plasma product will be collected. In both cases, the target volume will be less than 800 mL.

[0086] As can be understood, the higher the accuracy of the donor's hematocrit as determined before and during the procedure, the more likely the target volume of the collected plasma product is to include the maximum volume of raw plasma that can be collected for a particular donor. As described above, the donor's hematocrit during the procedure is based on the assumption that 100% of the red blood cells drawn in each aspiration cycle are reinfused in each return cycle along with 100% of the non-RBC cell product and a certain volume of anticoagulant. However, it has been determined that during the blood separation procedure, interstitial fluid shifts into the intravascular space, thereby restoring half of the drawn volume. See Saito et al., Interstitial fluid shifts to plasma compartment during blooddonation, published in Transfusion 2013;53(11):2744-50. In each return phase, the shifted interstitial fluid is also reinfused in addition to the red blood cells, non-RBC cell product, and anticoagulant. Therefore, considering that the transfer of interstitial fluid will lead to a more accurate determination of hematocrit and thus a more precise determination of the target volume of plasma products, this will yield the maximum amount of raw plasma.

[0087] The transfer of interstitial fluid during plasma retrieval has been confirmed by tracking donor immunoglobulin G (IgG) levels during the process. See, for example, Burkhardt et al., *Immunoglobulin G levels during collection of large volume plasma forfractionation*, published in *Transfusion* 2017;56:417-420. Without interstitial fluid transfer, donor IgG levels would remain stable during plasma retrieval. However, IgG levels have been shown to decrease, and the amount of decrease is a function of the volume of interstitial fluid that has transferred into the bloodstream.

[0088] Reference Figure 12 The figure shows a curve of collected plasma volume (along the X-axis) versus IgG concentration (along the Y-axis), based on experiments. It can be seen that from a baseline of zero collected plasma (at the start of the process) to 200 mL of collected plasma, the donor's IgG decreased by 9%, and from 200 mL of collected plasma to 800 mL of collected plasma, the donor's IgG decreased by an additional 4%. This can be attributed to the transfer of interstitial fluid equaling approximately 9% of the donor's initial total blood volume (after 200 mL of plasma was collected) to approximately 13% of the donor's initial total blood volume (after 800 mL of plasma was collected).

[0089] based on Figure 12 The curve has established the following relationship between the donor's IgG concentration and the volume of plasma collected: y = 1.0017x -0.02 Where y = IgG concentration and x = plasma volume collected. Therefore, the proportion of donor blood volume replaced by interstitial fluid transfer is equal to V. b (1-y), where V b This is the initial volume of the donor's whole blood. Therefore, the transfer volume of interstitial fluid can be calculated based on the volume of collected plasma, and this amount can be added to the volumes of re-infused red blood cells, non-RBC cell products, and anticoagulants at each return stage to determine the donor's current total blood volume and thus hematocrit. As will be understood, the controller can be configured to automatically determine the volume of transferred interstitial fluid based on the volume of collected plasma and include this transferred volume when determining the donor's hematocrit before each aspiration stage.

[0090] Alternatively, other methods can be used to directly measure the donor's hematocrit, such as optical sensors, or, if a centrifuge is used, to measure the volume of red blood cells in the centrifuge.

[0091] Additionally, anticoagulants are typically introduced into disposable kits during a pretreatment step before the plasma extraction process begins, such as for pre-injection of the kits to perform one or more pre-cycles or for other pre-processing steps. The anticoagulant used for these purposes can be taken into account when determining the volume of raw plasma collected in the plasma collection container—which results in the target volume of collected raw plasma—as the anticoagulant will ultimately be directed directly to the plasma product collection container. This can be accomplished, for example, by measuring the weight of the container “filled” with anticoagulant and the weight of the container with anticoagulant before the first aspiration cycle begins, and adding the volume of anticoagulant to the target volume of the plasma product. The controller can be configured to automatically perform the steps necessary to account for the anticoagulant introduced into the plasma collection container separately from the anticoagulated plasma.

[0092] The methods and systems described above have several aspects. In a first aspect, a method for collecting plasma is provided, wherein plasma products are collected in multiple collection stages, and between said multiple collection stages, separated red blood cells are re-infused to a donor. The method of this first aspect includes: a) determining the volume V of the donor's whole blood. b a) Determine the volume of raw plasma (V) that can be collected from the donor, including hematocrit (Hct); b) Determine the volume of raw plasma (V) that can be collected from the donor. RP c) Determine the volume V of the plasma product that can be collected. PPThe process includes: d) drawing whole blood from the donor; e) introducing the anticoagulant (ACR) into the drawn whole blood at a specific ratio; f) separating the drawn whole blood into the plasma product and a second component containing red blood cells; g) collecting the plasma product in a plasma collection container; h) returning the red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and i) determining the donor's Hct and V before each collection stage. PP .

[0093] In the second aspect, continue steps d) through i) until the measured volume of the plasma product in the collection container equals V. PP until.

[0094] In a third aspect, a method for collecting plasma is provided, wherein plasma products are collected in multiple collection stages, and between said multiple collection stages, separated red blood cells are re-infused to a donor. The method of the second aspect includes: a) determining the volume V of the donor's whole blood. b and hematocrit (Hct); b) based on V b Determine the volume V of raw plasma that can be collected from the donor. RP c) Determine the amount to be added to V based on the anticoagulant ratio (ACR) and the donor's Hct. RP The volume V of the anticoagulant AC This makes V AC =V RP *(ACR*(1-Hct)); d) Determine the volume V of the plasma product that can be collected. PP Plasma products include raw plasma volume V RP Volume V of anticoagulant added AC e) Draw whole blood from the donor; f) Introduce an anticoagulant (ACR) into the drawn whole blood at a specific ratio; g) Separate the drawn whole blood into plasma products and a second component containing red blood cells; h) Collect the plasma products in a plasma collection container; i) Return red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and j) Determine the donor's Hct and V before each collection stage. PP .

[0095] In the fourth aspect, continue steps d) through j) until the measured volume of the plasma product in the collection container equals V. PP until.

[0096] Fifthly, V b It is determined based on one or more donor-specific characteristics, including the donor's weight, height, gender, age, and body type.

[0097] Fourthly, a method for collecting a certain volume V during a single-sample process is provided.PP A method for producing plasma products, wherein plasma products are collected in multiple collection stages, and between said multiple collection stages, separated red blood cells are re-infused to the donor. In the fourth aspect of the method, V PP Equal to the volume V of raw plasma that can be collected from the donor. RP Add to V during the single-collection process RP Anticoagulant V AC The volume. The steps of the method include: a) determining the donor's weight W. kg a) Determine the donor's sex (M or F); b) Determine the donor's hematocrit (Hct); c) Based on the donor's weight (W) kg The volume V of raw plasma that can be collected is determined by gender M or F. RP ;d) Determine V based on the anticoagulant ratio and the donor's Hct PP With V RP The ratio K between them makes K = V PP / V RP e) Determine V PP This makes V PP =V RP *k; f) Draw whole blood from the donor; g) Introduce an anticoagulant (ACR) into the drawn whole blood at a specific ratio; h) Separate the drawn whole blood into plasma products and a second component containing red blood cells; i) Collect the plasma products in a plasma collection container; j) Return the red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and k) Determine the donor's Hct and target V before each collection stage. PP .

[0098] In the fifth aspect, repeat steps c) through k) until the measured volume of the plasma product in the collection container equals V. PP Until then. Preferably, K = V PP / V RP =(ACR*(1-Hct / 100)+1) / (ACR*(1-HCT / 100)).

[0099] Fifthly, a method for collecting a certain volume V during a single sampling process is provided. PP A method for producing plasma products, wherein plasma products are collected in multiple collection stages, and between said multiple collection stages, separated red blood cells are re-infused to a donor. In this fifth aspect, V PP Equal to the volume V of raw plasma that can be collected from the donor. RP Add to V during the single-collection process RP The volume V of the anticoagulant AC The steps of this method include: a) determining the donor's weight W kga) Determine the donor's sex (M or F); b) Determine the donor's hematocrit (Hct); c) Based on the donor's weight (W) kg The donor's sex (M or F) determines the volume (V) of raw plasma that can be collected. RP ;d) Determine the amount to be added to V based on the anticoagulant ratio (ACR) and the donor's Hct. RP V AC This makes V AC =V RP *(ACR*(1-Hct)); e) Determine V PP This makes V PP =V RP +V AC f) Draw whole blood from the donor; g) Introduce an anticoagulant (ACR) into the drawn whole blood at a specific ratio; h) Separate the drawn whole blood into plasma products and a second component containing red blood cells; i) Collect the plasma products in a plasma collection container; j) Return the red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and k) Determine the donor's Hct and V before each collection stage. PP .

[0100] In the sixth aspect, continue steps d) through k) until the measured volume of the plasma product in the collection container equals V. PP until.

[0101] In the seventh aspect, V RP The following method is used to determine V for each of the multiple ranges of donor weight. RP And select V for a weight range including the donor's weight. RP Donor weight can be divided into three categories: from 110 to 149 pounds, from 150 to 174 pounds, and over 175 pounds.

[0102] In the eighth aspect, V RP =K1*W kg .

[0103] In the ninth aspect, V RP Not greater than (1-Hct)*(V) b 28.6% of ).

[0104] In the tenth aspect, V b It is determined using one of the following methods: Nadler's equation, Gilcher's quintile method, ICSH criteria, or any other generally accepted method.

[0105] In the eleventh aspect, V RP =W kg *10mL / kg.

[0106] In the twelfth aspect, donor parameters are used to estimate the total blood volume V of the donor. b At that time, V RP =K2*V b .

[0107] In the thirteenth aspect, an automated system for separating plasma from whole blood is provided, the automated system comprising reusable hardware components and disposable kits. The disposable kit also includes: i) a separator for separating whole blood into a plasma fraction and a concentrated cell fraction, the separator having an inlet, a plasma outlet port, and a concentrated cell outlet port, the inlet having a blood line integrally connected to the inlet for transferring whole blood from the donor to the separator, the plasma outlet port being integrally connected to a plasma collection container via the plasma line, and the concentrated cell outlet port being integrally connected to a reservoir for receiving concentrated cells prior to re-infusion to the donor; ii) a donor line terminating at a venipuncture needle for transferring whole blood from the donor to the blood line; iii) an anticoagulant line integrally connected to the blood line and configured to connect to an anticoagulant source for transferring anticoagulant to the donor line; iv) a saline line configured to connect to a saline source for transferring saline to the blood line; and v) a re-infusion line for transferring concentrated cells from the reservoir to the donor line. The reusable hardware components also include: i) a peristaltic first pump for delivering anticoagulant at a controlled rate into the blood line during the collection phase; ii) a second pump for delivering anticoagulant whole blood to a separator during the collection phase and returning concentrated cell fractions during the re-infusion phase; iii) a third pump for delivering concentrated cell fractions from the separator to a reservoir during the collection phase; iv) clamps associated with each of the blood line, plasma line, re-infusion line, and saline line; v) a weighing scale for weighing each of the plasma collection container, reservoir, and anticoagulant source; and vi) a programmable controller including a touchscreen for receiving input from the operator, the programmable controller being configured to receive signals from each weighing scale and automatically operate the first, second, and third pumps and the clamps to separate whole blood into plasma and concentrated cell fractions during the collection phase and to return concentrated cells to the donor during the re-infusion phase. The programmable controller is also configured to determine the weight of the plasma fraction to be collected in the plasma collection container according to any of the aspects described herein, and the programmable controller is configured to terminate the collection phase upon receiving a signal from a weighing scale indicating that the weight of the plasma fraction in the plasma collection container is equal to the weight determined by the controller. When determining the target amount of plasma product to be collected, the controller may be configured to calculate the donor's hematocrit before the collection phase of each cycle. Alternatively or additionally, the controller may receive a signal from a sensor, etc., indicating the donor's hematocrit. Furthermore, the amount of plasma product in the plasma collection container may be determined, for example, by a weighing scale associated with plasma collection. In one embodiment, the separator includes a rotating diaphragm separator.

[0108] It will be understood that the described embodiments illustrate some applications of the principles of this subject matter. Many modifications can 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 is not limited to the foregoing description, but is set forth in the appended claims.

Claims

1. A system for collecting plasma, comprising: A separator configured to separate whole blood into a plasma product and a second blood component including red blood cells, the blood separator having a plasma output port connected to a plasma line configured to transport the plasma product to a plasma product collection container; A donor line, the donor line being configured to introduce the whole blood from the donor into the separator, the flow through the donor line being controlled by a blood pump; An anticoagulant line connected to an anticoagulant source, through which flow is controlled by an anticoagulant pump to combine the anticoagulant with the whole blood from the donor based on the anticoagulant ratio (ACR); A touchscreen configured to receive input from an operator; as well as A controller, programmed to control the operation of the system, is coupled to the touchscreen and programmed to electronically receive donor parameters from a donor management system to use a target volume of raw plasma at least partially based on the donor parameters, including height and weight for calculating the total donor blood volume and hematocrit Hct for calculating the total donor plasma volume, wherein the target volume of raw plasma is set before blood is collected from the donor; the controller is configured to control the system to operate an aspiration phase and a return phase to draw whole blood from the donor and separate the whole blood into the plasma product and the second blood component, and to return the second blood component to the donor, wherein the controller is further configured to operate the aspiration phase and the return phase until the volume V of raw plasma in the collection container reaches a certain value. RP The volume V of the raw plasma is equal to the target volume of the raw plasma. RP Measurement volume V of plasma products PP The relationship is represented as: V PP / V RP =(ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)).

2. The system according to claim 1, wherein, ACR = Volume of whole blood / Volume of anticoagulant.

3. The system according to claim 1, wherein, The measured volume V of the plasma product PP Measured using a weight scale.

4. The system according to claim 1, wherein, The controller is configured to electronically receive the donor's weight and hematocrit from the donor management system, wherein the donor management system is used for eligibility screening.

5. The system according to claim 1, wherein, The controller is programmed to calculate the target volume of raw plasma by calculating the total donor blood volume or a portion of the total donor plasma volume.

6. The system according to claim 1, wherein, The controller is programmed to perform aspiration and return cycles at least three times, and the controller is programmed to determine the volume of whole blood to be aspirated in the final aspiration phase, the volume of whole blood to be aspirated in the final aspiration phase being different from the volume aspirated in the previous aspiration phase.

7. The system according to claim 1, wherein, Whole blood is drawn from the donor during the collection phase, and the second blood component is returned to the donor during the return phase.

8. The system according to claim 1, wherein, The controller is configured to control the operation of the system to combine the anticoagulant with the whole blood from the donor at an anticoagulant ratio (ACR) of 16 parts whole blood to 1 part anticoagulant.

9. The system according to claim 1, wherein, The donor management system calculates the target volume of raw plasma based at least in part on donor height and weight for calculating total donor blood volume and hematocrit for calculating total donor plasma volume, wherein the donor management system transmits the target volume of raw plasma to the controller.

10. A system for collecting plasma, comprising: A blood separator configured to separate whole blood into a plasma product and a second blood component including red blood cells, the blood separator having a plasma output port connected to a plasma line configured to transport the plasma product to a plasma product collection container; A donor line, configured to introduce whole blood from a donor into the blood separator, with flow through the donor line controlled by a blood pump; An anticoagulant line connected to an anticoagulant source, through which flow is controlled by an anticoagulant pump to combine the anticoagulant with the whole blood from the donor based on the anticoagulant ratio (ACR); as well as A touchscreen configured to receive input from an operator; as well as A controller, programmed to control the operation of the system, is coupled to the touchscreen and programmed to electronically receive donor parameters from a donor management system to determine, at least in part, a target volume for plasma products and / or raw plasma, based on the donor parameters, including height and weight for calculating the total donor blood volume and hematocrit (Hct) for calculating the total donor plasma volume. The controller is configured to control the system to operate a collection and retransfusion cycle to draw whole blood from the donor and separate the whole blood into the plasma product and a second blood component, and to retransfuse the second blood component back to the donor. The controller is programmed to perform the collection and retransfusion cycle at least three times, and is programmed to perform the final collection and retransfusion cycle by aspirating a volume of whole blood smaller than the volume aspirated in the previous collection and retransfusion cycle. Specifically, for each collection stage of the collection and reinfusion cycle, the target volume of plasma products and / or raw plasma is recalculated.

11. The system according to claim 10, wherein, The controller is also configured to operate the collection and re-infusion cycle until the volume V of the raw plasma in the collection container reaches a certain level. RP Until the target volume equals the raw plasma volume.

12. The system according to claim 11, wherein, ACR = Volume of whole blood / Volume of anticoagulant.

13. The system according to claim 11, wherein, 500 mL of whole blood was collected during the first collection phase of the collection and re-infusion cycle.

14. The system according to claim 10, wherein, The supplier management system is used for qualification screening and communicates electronically with the controller.

15. The system according to claim 14, wherein, The donor management system is programmed to calculate the target volume of plasma products and / or raw plasma, and the controller is programmed to determine the target volume of plasma products and / or raw plasma by receiving the target volume of plasma products and / or raw plasma from the donor management system.

16. The system according to claim 10, wherein, The controller determines the target volume of the plasma product and / or raw plasma by calculating the target volume of the plasma product and / or raw plasma, and wherein the controller is located locally in the blood separator and connected to the blood separator.

17. The system according to claim 10, wherein, The controller is programmed to determine the total donor blood volume before drawing whole blood from the donor during blood donation.

18. The system according to claim 10, wherein, The controller is programmed to determine the target volume of a plasma product comprising raw plasma and an anticoagulant, wherein the target volume of the plasma product is determined at least in part based on the anticoagulant ratio, the donor's weight, and the donor's hematocrit before the whole blood is drawn from the donor.

19. The system of claim 10 further includes a reservoir separate from the blood separator, the reservoir being used to receive concentrated red blood cells.

20. A system for collecting plasma, comprising: A separator configured to separate whole blood into a plasma product and a second blood component including red blood cells, the separator having a plasma output port connected to a plasma line configured to transport the plasma product to a plasma product collection container; A donor line configured to introduce the whole blood from a donor into the separator; An anticoagulant line connected to an anticoagulant source, the anticoagulant line being configured to bind the anticoagulant to the whole blood from the donor based on an anticoagulant ratio (ACR); A touchscreen configured to receive input from an operator; as well as A controller, configured to control the operation of the system, is coupled to the touchscreen and configured to electronically receive donor parameters from a donor management system to use a target volume of raw plasma based at least in part on donor height and weight for calculating total donor blood volume. The donor parameters include hematocrit (Hct) for calculating total donor plasma volume. The target volume of the raw plasma is based on the total donor blood volume, wherein the target volume of the raw plasma is set before blood is collected from the donor. The controller controls the system to operate an aspiration phase and a return phase to draw whole blood from the donor and separate the whole blood into the plasma product and the second blood component, and to return the second blood component to the donor. The controller is further configured to operate the aspiration phase and the return phase until the volume V of the raw plasma in the collection container reaches a certain value. RP The volume V of the raw plasma is equal to the target volume of the raw plasma. RP Measurement volume V of plasma products PP The relationship is represented as: V PP / V RP =(ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)).

21. The system according to claim 20, wherein, ACR = Volume of whole blood / Volume of anticoagulant.

22. The system according to claim 20, wherein, The measured volume V of the plasma product PP Measured using a weight scale.

23. The system according to claim 22, wherein, The controller is configured to measure the volume V of the plasma product. PP The volume V of the raw plasma in the collection container is calculated using the anticoagulant ratio (ACR) and the donor's hematocrit. RP .

24. The system according to claim 20, wherein, The controller is configured to electronically receive the donor's weight and hematocrit from the donor management system, wherein the donor management system is used for eligibility screening.

25. The system of claim 24, further comprising the supplier management system.

26. The system according to claim 20, wherein, The target volume of raw plasma is based on the volume of raw plasma from the donor.

27. The system according to claim 26, wherein, The controller is configured to calculate the target volume of the raw plasma by calculating a portion of the donor's plasma volume.

28. The system according to claim 20, wherein, The controller is configured to perform aspiration and return cycles at least three times, and the controller is configured to determine the volume of whole blood to be aspirated in the final aspiration phase, the volume of whole blood to be aspirated in the final aspiration phase being different from the volume aspirated in the previous aspiration phase.

29. The system according to claim 28, wherein, During the first aspiration phase of aspiration and return to circulation, 500 mL of whole blood was aspirated.

30. The system of claim 20 further includes a venipuncture needle, said venipuncture needle being a single needle through which whole blood is aspirated from the donor during the collection phase, and the second blood component being returned to the donor during the return phase.

31. The system according to claim 20, wherein, The controller is configured to control the operation of the system to combine the anticoagulant with the whole blood from the donor at an anticoagulant ratio (ACR) of 16 parts whole blood to 1 part anticoagulant.

32. The system according to claim 20, wherein, The donor management system calculates the target volume of raw plasma based at least in part on donor height and weight for calculating total donor blood volume and hematocrit for calculating total donor plasma volume, wherein the donor management system transmits the target volume of raw plasma to the controller.

33. The system according to claim 20, wherein, The controller is configured to use hematocrit (Hct) to calculate the total donor plasma volume, and the target volume of the raw plasma is based on the total donor plasma volume.

34. The system according to claim 20, wherein, The controller is configured to receive donor ID, donor weight, donor hematocrit, and target plasma volume from the touchscreen.

35. The system according to claim 34, wherein, The controller is configured to calculate the target volume of raw material plasma by establishing three donor weight ranges and selecting the target volume of raw material plasma for the weight ranges including the donor weights.

36. The system according to claim 35, wherein, The controller is configured to calculate the target volume of raw plasma by multiplying the weight of the donor by a constant.

37. A system for collecting plasma, comprising: A blood separator configured to separate whole blood into a plasma product and a second blood component including red blood cells, the blood separator having a plasma output port connected to a plasma line configured to transport the plasma product to a plasma product collection container; A donor line configured to introduce whole blood from a donor into the blood separator; An anticoagulant line connected to an anticoagulant source, the anticoagulant line being configured to bind the anticoagulant to the whole blood from the donor based on an anticoagulant ratio (ACR); A touchscreen configured to receive input from an operator; as well as A controller, configured to control the operation of the system, is coupled to the touchscreen and configured to electronically receive donor parameters from a donor management system to determine a target volume of plasma product and / or raw plasma, the target volume of plasma product and / or raw plasma being at least partially based on donor height and weight for calculating total donor blood volume and hematocrit (Hct) for calculating total donor plasma volume. The controller is configured to control the system to operate a collection and retransfusion cycle to draw whole blood from the donor and separate the whole blood into the plasma product and a second blood component, and to retransfuse the second blood component back to the donor. The controller is programmed to perform at least three collection and retransfusion cycles, and the controller is programmed to perform a final collection and retransfusion cycle by aspirating a volume of whole blood smaller than the volume aspirated in the previous collection and retransfusion cycle. Specifically, for each collection stage of the collection and reinfusion cycle, the target volume of plasma products and / or raw plasma is recalculated.

38. The system according to claim 37, wherein, The controller is configured to use the donor parameters received from the donor management system to determine the target volume of plasma product / raw plasma.

39. The system of claim 37, further comprising the supplier management system, wherein, The supplier management system is used for qualification screening and communicates electronically with the controller.

40. The system according to claim 39, wherein, The donor management system is configured to calculate the target volume of plasma products and / or raw plasma, and the controller is configured to determine the target volume of plasma products and / or raw plasma by receiving the target volume of plasma products and / or raw plasma from the donor management system.

41. The system according to claim 37, wherein, The controller is configured to determine the target volume of the plasma product and / or raw plasma by calculating the target volume of the plasma product and / or raw plasma, and wherein the controller is located locally in the blood separator and connected to the blood separator.

42. The system according to claim 37, wherein, The controller is configured to determine the total donor blood volume before drawing whole blood from the donor during blood donation.

43. The system according to claim 37, wherein, The controller is configured to determine the target volume of a plasma product comprising raw plasma and an anticoagulant, wherein the target volume of the plasma product is determined at least in part based on the anticoagulant ratio, the donor's weight, and the donor's hematocrit before the whole blood is drawn from the donor.

44. A system for collecting plasma, comprising: A separator configured to separate whole blood into plasma products and red blood cells, the separator having a plasma output port connected to a plasma line configured to transport the plasma products to a plasma product collection container; A donor line configured to introduce the whole blood from a donor into the separator; An anticoagulant line connected to an anticoagulant source, the anticoagulant line being configured to introduce anticoagulant into the whole blood from the donor based on an anticoagulant ratio (ACR); A touchscreen configured to receive input from an operator; as well as A controller, configured to control the operation of the system, is coupled to the touchscreen and configured to electronically receive donor parameters from a donor management system to use a target volume of plasma product and / or raw plasma based at least in part on donor height and weight for calculating total donor blood volume, the target volume of plasma product and / or raw plasma being based on the total donor blood volume. The controller controls the system to operate at least three aspiration and return phases to aspirate whole blood from the donor and separate the whole blood into the plasma product and the red blood cells, and to return the red blood cells to the donor. Specifically, for each aspiration stage and return stage, the target volume of plasma product and / or raw plasma is recalculated, and The controller is configured to determine the volume of whole blood to be aspirated in the final aspiration phase, wherein the volume of whole blood to be aspirated in the final aspiration phase is less than the volume aspirated in the previous aspiration phase.

45. The system according to claim 44, wherein, The target volume of plasma products and / or raw plasma is set before blood is collected from the donor.

46. ​​The system according to claim 44, wherein, The controller is also configured to operate the aspiration phase and the return phase until the volume V of the raw plasma in the collection container is reached. RP The volume V of the raw plasma is equal to the target volume of the raw plasma. RP Measurement volume V based on plasma products PP of.

47. The system according to claim 44, wherein, ACR = Volume of whole blood / Volume of anticoagulant.

48. The system according to claim 46, wherein, The measured volume V of the plasma product PP Measured using a weight scale.

49. The system according to claim 48, wherein, The controller is configured to measure the plasma product volume V. PP The volume V of the raw plasma in the collection container is calculated using the anticoagulant ratio (ACR) and the donor's hematocrit. RP .

50. The system according to claim 44, wherein, The controller is configured to electronically receive the donor's weight and hematocrit from the donor management system, wherein the donor management system is used for eligibility screening.

51. The system of claim 50, further comprising the supplier management system.

52. The system according to claim 44, wherein, The target volume of plasma products and / or raw plasma is based on the volume of raw plasma from the donor.

53. The system according to claim 52, wherein, The controller is configured to calculate the target volume of plasma products and / or raw plasma by calculating a portion of the donor's plasma volume.

54. The system according to claim 44, wherein, During the first aspiration phase of aspiration and return to circulation, 500 mL of whole blood was aspirated.

55. The system according to claim 44, wherein, The controller is configured to collect a predetermined amount of whole blood from the donor during the aspiration phase of the at least three aspiration phases and the return phase, wherein the controller is configured to perform a final mini-collection cycle of less than the predetermined amount.

56. The system of claim 44 further includes a venous puncture needle, said venous puncture needle being a single needle through which whole blood is aspirated from the donor during the collection phase, and the red blood cells being returned to the donor during the return phase.

57. The system according to claim 44, wherein, The controller is configured to control the operation of the system to combine the anticoagulant with the whole blood from the donor at an anticoagulant ratio (ACR) of 16 parts whole blood to 1 part anticoagulant.

58. The system according to claim 44, wherein, The donor management system calculates the target volume of raw plasma based at least in part on donor height and weight, which are used to calculate the total donor blood volume, wherein the donor management system transmits the target volume of raw plasma to the controller.

59. The system according to claim 44, wherein, The controller is configured to use hematocrit (Hct) to calculate the total donor plasma volume, and the target volume of plasma products and / or raw plasma is based on the total donor plasma volume.

60. The system according to claim 44, wherein, The controller is configured to receive donor ID, donor weight, donor hematocrit, and target plasma volume from the touchscreen.

61. The system according to claim 44, wherein, The controller is configured to calculate the target volume of raw material plasma by establishing three donor weight ranges and selecting the target volume of raw material plasma for the weight ranges including the donor weights.

62. The system according to claim 61, wherein, The controller is configured to calculate the target volume of raw plasma by multiplying the weight of the donor by a constant.

63. The system according to claim 44, wherein, The controller is configured to use the donor parameters received from the donor management system to determine the target volume of plasma products and / or raw plasma.

64. The system of claim 44, further comprising the supplier management system, wherein, The supplier management system is used for qualification screening and communicates electronically with the controller.

65. The system according to claim 44, wherein, The donor management system is configured to calculate the target volume of plasma products and / or raw plasma, and the controller is configured to receive the target volume of plasma products and / or raw plasma from the donor management system.

66. The system according to claim 44, wherein, The controller is configured to determine the target volume of the plasma product and / or raw plasma by calculating the target volume of the plasma product and / or raw plasma, and wherein the controller is located locally in the blood separator and coupled to the blood separator.

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