A system for plasma collection using remote programming

Abstract

A system and method for collecting plasma, the method comprising: drawing whole blood from a donor; combining an anticoagulant with the whole blood from the donor; separating the whole blood into a plasma product and a second blood component; and transporting the plasma product to a collection container. A controller receives parameters from a remote computer via a network, receives user input to confirm the parameters and / or process, determines a target volume of the plasma product and / or raw plasma based on the parameters, and controls the system to collect plasma using aspiration and return phases in response to confirming the donor.

Description

Technical Field

[0001] The present application relates to systems and methods for performing plasmapheresis, and more particularly to systems and methods for plasmapheresis in which the volume of source plasma or raw plasma product that can be collected from a particular donor is optimized. The present subject matter also relates to systems and methods for controlling a medical procedure performed on a recipient. Background Art

[0002] Plasmapheresis 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 the cellular blood components are then returned to the donor. Separation of plasma from the cellular components is typically accomplished in an automated process by centrifugation or membrane filtration.

[0003] In automated plasmapheresis, whole blood is drawn from a 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 a target volume of anticoagulated plasma (or "plasma product") has been collected as determined by a weight scale associated with the plasma collection container, the drawing of whole blood 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 re-infusion cycles until the total target volume of anticoagulated plasma has been collected. The anticoagulated plasma is used for subsequent transfusions or further production.

[0004] Plasma collected to serve as source material for further production ("source plasma") is collected from multiple donors and combined or pooled together for this purpose. The FDA has issued guidance to registered blood collection centers regarding the volume of plasma that can be collected as source plasma during plasmapheresis in order to improve the consistency of the process used to produce source plasma and minimize the opportunity for human error. (FDA Regulation: "Volume Limits-Automated Collection of Source Plasma (11 / 4 / 92)"). The FDA regulation mentions the inconsistencies caused by the various types of anticoagulant solutions used, different concentrations of anticoagulants, and different ranges of anticoagulant to plasma ratios.

[0005] The FDA regulation provides a simplified plasma volume nomogram, which is reproduced in Figure 1In the chart shown in , the volume (or weight) of plasma that can be collected from a particular donor is limited to ensure the safety and comfort of the donor. More specifically, the FDA nomogram limits the volume (or weight) of plasma based on the weight of the donor and establishes a volume of anticoagulant that can be added at a ratio of 1:16 anticoagulant to anticoagulated blood or 0.06 parts anticoagulant to 1 part anticoagulated blood to achieve the maximum collection volume for a particular donor as the sum of plasma plus anticoagulant.

[0006] The simplified nomogram given in the FDA regulations has been the primary method used by blood collection centers to determine the collection volume of plasma products. Therefore, plasmapheresis equipment used in such centers is typically programmed to collect a specific volume / weight of anticoagulated plasma (assuming the density is known) 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.

[0007] One simplification made in the FDA nomogram is that the donor hematocrit is not considered when determining the collection volume of a plasma product. However, the relative proportions of raw plasma to anticoagulant in a plasma product depend on the donor's hematocrit and the ratio of the AC to the donor's whole blood combination. As a result, donors with higher hematocrits reach the maximum collection volume given in the FDA nomogram before reaching the maximum volume of (raw) plasma that can be safely collected from that donor. This creates inefficiencies in plasma collection centers because the volume of raw plasma collected is less than the maximum amount possible.

[0008] Furthermore, 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 the volume of plasma).

[0009] As source plasma from multiple donors is combined, maximizing the volume of plasma that can be collected from each individual donor is very important, because even a small increase in the volume collected from each individual donor, when added together, can result in a meaningful increase in the total volume of combined plasma. If plasmapheresis equipment can better target the raw plasma volume, more plasma proteins can be collected from each donor, thereby improving the overall efficiency of the plasma collection center. Therefore, through the present disclosure, systems and methods for optimizing the volume of collected plasma consistent with donor safety and comfort are provided.

[0010] The parameters according to which at least partially automated medical procedures are performed, including but not limited to blood donation and apheresis, should correspond to or be adapted to the characteristics of the donor or patient for whom the procedure is performed. For example, when performing a blood donation procedure, it may be advantageous to consider multiple parameters such as the gender and weight of the donor or patient. If incorrect operating parameters are used, the process may be less efficient than otherwise and / or may be harmful to the donor or patient in some cases. Therefore, care should be taken that the operating parameters correspond to the unique characteristics of the donor or patient.

[0011] Information about the donor or patient may exist in a data sheet or written prescription and is entered into the automated device or system by a system operator (e.g., a nurse, doctor, or technician) through a user interface at the beginning of the process. The operator confirms the system's settings and the recipient's identity, and then instructs the system to initiate the medical process. Since manual data entry is relied upon, there is of course the risk of operator error resulting in operating parameters that do not correspond to the unique characteristics of the donor or patient. Therefore, systems and methods that reduce the risk of data entry errors would be advantageous. Summary of the invention

[0012] Through the present disclosure, methods are provided for operating a plasmapheresis system to collect a volume of anticoagulated plasma (i.e., a plasma product) that ensures that the total volume of raw plasma in the plasma product is the maximum value that can be collected from a particular donor consistent with the safety and comfort of the donor, whether indicated by the unique physical characteristics of the donor or by an FDA nomogram or some other method.

[0013] According to a first aspect of the present disclosure, a method is provided for operating a plasmapheresis system to collect a plasma product volume that includes a maximum allowable volume / weight of raw plasma according to limitations given in an FDA nomogram based on donor weight.

[0014] In order to collect the maximum volume / weight of raw plasma allowed by the FDA nomogram, a modified nomogram is provided that utilizes the donor's hematocrit to calculate a target volume / weight of a plasma product having the maximum volume of raw plasma allowed by the FDA nomogram. The calculated volume / weight of raw plasma is compared to the maximum volume / weight of raw plasma allowed by the FDA nomogram. If the calculated volume / weight of raw plasma is less than the maximum allowed volume / weight, the volume / weight of the plasma product to be collected is adjusted upward by an amount equal to the difference plus an additional amount of anticoagulant added to handle the additional volume / weight of plasma, based on the maximum volume / weight allowed by the FDA nomogram for the plasma product.

[0015] Therefore, knowing 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 nomogram is determined, and the total volume / weight of the plasma product to be collected is then adjusted accordingly based on the weight of the donor given in the FDA nomogram.

[0016] Typically, the plasmapheresis process includes a continuous cycle of alternating phases, one of which is drawing whole blood from a donor and separating and collecting plasma, and another of which is returning the separated red blood cells and any other non-RBC cellular components to the donor. The donor's hematocrit will change during the plasmapheresis process, thereby affecting the amount of anticoagulant in the collected plasma product from one cycle to the next.

[0017] Thus, in a first aspect of the present disclosure, a new hematocrit value for the donor is determined prior to initiating subsequent draw / separation phases, and the target volume / weight of the plasma product for the process is recalculated prior to initiating each draw / separation phase to ensure that the maximum amount of raw plasma permitted by the FDA nomogram is collected.

[0018] According to a second aspect, another method for collecting a certain amount of plasma during an apheresis process is provided. The steps of the method include: determining the total whole blood volume V of the donor b ; Based on V b Determine the volume of raw plasma (V) that can be collected from the donor RP ); determining the target volume of plasma product to be collected (V) based on the anticoagulant ratio (ACR, defined as the ratio of the donor blood volume to the anticoagulant volume for donor blood without anticoagulant) established for the process and the donor's Hct; PP ), where V PP Equal to the volume of raw plasma to be collected (V RP ) is added to V during the apheresis process RP The volume of anticoagulant (V AC ), so that V PP =V RP *K, wherein K = (ACR * (1-Hct / 100) + 1) / (ACR * (1-Hct / 100)); draw whole blood from a donor; add an anticoagulant to the whole blood in an amount consistent with the ACR; separate a plasma product from the whole blood; and transfer the plasma product to a collection container until the volume of the plasma product in the collection container reaches V PP Since the plasmapheresis process includes multiple extraction / separation and return phases, the V for the process will be recalculated before each extraction / separation phase begins based on the value of the donor's hematocrit determined before the start of each aspiration phase. PP, and adjust the target volume of the plasma product accordingly. Alternatively, the target volume can be based on a calculated value of the donor's total plasma volume, which is based on V b and the donor's hematocrit - determine V RP .

[0019] In a third aspect, a method for determining the volume (V) of a plasma product that can be collected during an apheresis process is provided. PP ) method, wherein V PP Equal to the volume of raw plasma that can be collected (V RP ) is added to V during the apheresis process RP The volume of anticoagulant (V AC The method comprises the steps of: determining the weight of the donor (W kg ) and gender (M or F); determine the donor's hematocrit (Hct); based on the donor's weight (W kg ) and gender (M or F) determine the volume of raw plasma that can be collected (V RP ); based on the anticoagulant ratio (ACR) and the donor's Hct, determine V PP With V RP The ratio K between them makes K = V PP / V RP ; Determine V PP , so that V PP =V RP *K. In addition, K = (ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)). In determining V PP After the desired amount of whole blood has been drawn from the donor, the red blood cells are returned to the donor. The donor's Hct and V are then determined prior to each aspiration phase. PP .

[0020] In a related aspect, the aspirating step and the separating step are repeated until the volume of the plasma product in the collection container reaches V PP until.

[0021] In a related aspect, the donor's hematocrit after the first collection phase can be calculated by volume balance, assuming that the number of donor red blood cells is the same at the beginning of each aspiration cycle, and the total volume of blood decreases from one cycle to the next by 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 by an optical sensor or other sensor.

[0022] On the other hand, the volume of raw plasma that can be collected from a particular donor can be determined by any of several different ways. These ways include, for example, the FDA nomogram, which only considers the weight of the donor; a modified FDA nomogram that further considers the hematocrit of the donor and considers the portion of the total blood volume or total plasma volume calculated for the particular donor. The total blood volume or total plasma volume can be determined, for example, using the following: the Nadler equation; the Gilcher quintile method; the table provided by the International Council for Standardization of Hematology (ICSH); or any other generally accepted method that uses the height, weight, sex, and age of the donor that is consistent with the safety and comfort of the donor.

[0023] 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 also comprises: i) a separator for separating whole blood into a plasma portion and a concentrated cell portion, 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 conveying whole blood from a donor to the separator, the plasma output port integrally connected to a plasma collection container via a plasma line, the concentrated cell outlet port integrally connected to a reservoir for receiving concentrated cells prior to reinfusion into the donor; ii) a donor line terminating in a venipuncture needle, the donor line for conveying whole blood from a donor to the blood line; iii) an anticoagulant line integrally connected to the blood line and configured to be connected to a source of anticoagulant, the anticoagulant line for conveying anticoagulant to the donor line; and iv) a re-infusion line for conveying concentrated cells from the reservoir to the donor line.

[0024] The reusable hardware components also include: i) a peristaltic first pump for delivering anticoagulant to the blood line at a controlled rate during the collection phase; ii) a second pump for delivering anticoagulated whole blood to a separator during the collection phase and returning the concentrated cell component during the re-infusion phase; iii) a third pump for delivering the concentrated cell component from the separator to a reservoir during the collection phase; iv) a clamp associated with each of the blood line, the plasma line, and the re-infusion line; v) a weight scale for weighing each of the plasma collection container, the reservoir, and the anticoagulant source; and vi) a programmable controller including a touch screen for receiving input from an operator, the programmable controller being configured to receive signals from each of the weight scales and automatically operate the first pump, the second pump, and the third pump and the clamp to separate whole blood into a plasma portion and a concentrated cell portion during the collection phase and to return the concentrated cells to the donor during the re-infusion 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. When determining the target amount of plasma product to be collected, the controller can be configured to calculate the donor's hematocrit prior to the collection phase of each cycle. Alternatively or additionally, the controller can receive a signal indicating the donor's hematocrit from a sensor or the like. In addition, the amount of plasma product in the plasma collection container can be determined by, for example, a weight scale associated with the plasma collection container or an optical sensor that directly measures the volume.

[0025] Several aspects of the subject matter may be implemented individually or together in the devices and systems described and claimed below. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the use of these aspects alone or to exclude the claiming of these aspects individually or in different combinations as set forth in the claims attached hereto.

[0026] In one aspect, a system for performing a medical procedure on a recipient is provided. The system includes a database, a user interface, a processing device, and a controller. The database is preprogrammed with one or more recipient data entries, each recipient data entry having recipient-specific information associated therewith. The user interface is adapted to receive an identity input from the recipient. The controller is associated or in communication with the database, the user interface, and the processing device, and is configured to compare the identity input with the recipient-specific information of the recipient data entries. If the identity input corresponds to the recipient-specific information of the recipient data entries, the controller commands the processing device to perform the medical procedure on the recipient. If the identity input does not correspond to the recipient-specific information of any of the recipient data entries, the controller generates an error signal that prevents the medical procedure from being performed on the recipient.

[0027] In another aspect, a method for performing a medical procedure on a recipient is provided. One or more recipient data entries are stored, each entry having recipient-specific information associated therewith. An identity input is received from the recipient. The identity input is compared to the recipient-specific information of the recipient data entries. If the identity input corresponds to the recipient-specific information of the recipient data entries, the medical procedure is performed on the recipient. If the identity input does not correspond to the recipient-specific information of any of the recipient data entries, an error signal is generated to prevent the medical procedure from being performed on the recipient. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a table showing the simplified nomogram set forth in the FDA regulation "Volume Limitations - Automated Collection of Source Plasma (11 / 4 / 92)".

[0029] Figure 2 is a perspective view of an exemplary plasmapheresis apparatus suitable for use with the systems and methods of the present application.

[0030] Figure 3 is able to Figure 2 A perspective view of a rotating membrane separator of the type incorporated in a disposable kit for use with a plasmapheresis system with portions cut away to show detail.

[0031] Figure 4 yes Figure 2 A perspective view of the front panel of a plasmapheresis system showing the components of the disposable kit mounted to the front panel.

[0032] Figure 5 is a schematic diagram illustrating the operation of the plasmapheresis system during the collection phase.

[0033] Figure 6 is a schematic diagram showing the operation of the plasmapheresis system during the re-infusion phase.

[0034] Figure 7 is a table showing the volumes of raw plasma based on donor hematocrit that are contained within the plasma product volume limits set by the FDA nomogram using a 1:16 ratio of anticoagulant to whole blood.

[0035] Figure 8 It shows that based on Figure 7 A table of the volumes of “unclaimed” raw plasma in plasma products showing the difference between the values ​​listed in and the maximum volume of raw plasma that can be collected based on the FDA nomogram.

[0036] Fig. 9 is a table showing the volume of plasma product that can be collected from a donor based on the donor's weight and hematocrit that will result in the maximum allowable volume of raw plasma allowed by the FDA nomogram.

[0037] Fig.10 is a table showing inputs to a programmable controller for performing a hypothetical plasmapheresis process according to the method of the present application.

[0038] Fig.11a , Fig.11b Includes a two-part table illustrating how the donor's hematocrit is based on Fig.10 The assumed plasma collection process based on the input in the table is increased, and results in an increase in the total collection volume of plasma product required to collect the target volume of raw plasma.

[0039] Fig.12 is a graph illustrating the dilution of IgG during plasmapheresis.

[0040] Fig.13 is a schematic diagram of a medical device according to an aspect of the present disclosure.

[0041] Fig.14 is a flow chart showing Fig.13 The process taken by a medical device when receiving identity information from a recipient and then performing a medical procedure on the recipient.

[0042] Fig.15 is a flow chart of a method for collecting plasma according to another illustrative embodiment.

[0043] Fig.16 is a schematic diagram of another medical device according to an aspect of the present disclosure. DETAILED DESCRIPTION

[0044] A more detailed description of the system and method according to the present disclosure will be set forth below. It should be understood that the following description of specific devices and methods is intended to be exemplary, rather than exhaustive of all possible variations or applications. Therefore, the scope of the present disclosure is not intended to be limiting and should be understood to encompass variations or implementations that would occur to a person of ordinary skill in the art.

[0045] In the context of the present application, plasmapheresis is performed on an automated system comprising a hardware component (or plasma collection device) generally indicated at 10 and a disposable kit generally indicated at 12 to collect plasma to be processed as source plasma. Figures 2 to 6 And as described in more detail below, the disposable set 12 consists of integrally connected separators, containers, and tubing for transporting blood and solutions within a sterile fluid path.

[0046] exist Figure 3 The separator 14 best seen in FIG. 1 has a rotating membrane filter 16 mounted to a rotor 18 for rotation within a housing 20 to separate the blood into its components. A detailed description of a rotating membrane separator can be found in U.S. Pat. No. 5,194,145 to Schoendorfer, which is incorporated herein by reference. As can be appreciated, in different systems, separation of whole blood can be accomplished by centrifugation. See, for example, U.S. Pat. No. 5,360,542 to Williamson et al.

[0047] During plasmapheresis, anticoagulated whole blood enters separator 14 through whole blood input port 22. Plasma is separated by a rotating membrane filter and then flows out of plasma output port 24, through plasma line 26, and into plasma collection container 28. Concentrated cells are pumped out of concentrated cell output port 30 into reservoir 32, where they are retained until reinfused into a donor.

[0048] The disposable kit 12 also includes the following tubing lines: a line for introducing whole blood from a donor into the system during collection and returning concentrated cells to the donor during re-infusion (donor line 34, which terminates in a venipuncture needle 36), as well as a line for transferring anticoagulated whole blood to a separator (blood line 38), a line for transferring concentrated cells to a reservoir (cell line 40), a line for transferring concentrated cells from a reservoir to a donor line (re-infusion line 42), a line for transferring plasma to a plasma collection container (plasma line 44), a line for saline (saline line 46), and a line for anticoagulant (AC line 48).

[0049] The hardware component 10 includes a programmable controller 50 and a touch screen 52 having a graphical user interface ("GUI") through which an operator controls the plasmapheresis process. For example, the GUI allows 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 regimen is selected), and target plasma volume. The touch screen 52 also enables the operator to collect status information and handle error conditions. The controller 50 may include digital and / or analog circuit components (e.g., microprocessors, microcontrollers, application specific integrated circuits, discrete components, surface mount components, printed circuit boards, and / or other circuits) configured (e.g., configured by being programmed) to perform the functions described herein.

[0050] Positioned on the front panel of the hardware assembly 10 are three peristaltic pumps, including an AC pump 54, a blood pump 56, and a cell pump 58. The AC pump 54 delivers an anticoagulant solution (AC) to the blood line 38 at a controlled rate as whole blood enters the kit from the donor. The blood pump 56 delivers anticoagulated whole blood to the separator during the collection phase of the plasmapheresis process and returns concentrated cellular components to the donor and replacement fluid to the donor if necessary during the re-infusion phase of the plasmapheresis process. The cell pump 58 delivers concentrated cellular components from the separator 14 to a reservoir during the collection phase.

[0051] In one embodiment, the hardware component 10 is a blood processing device configured to separate plasma and formed elements from whole blood, wherein the whole blood line has a pump 56 to control the inlet flow, and wherein an AC pump 54 is provided connected to the AC line, and wherein the plasma line is pumpless and plasma is only pushed to the plasma container.

[0052] The front panel also includes four clamps into which the disposable set 12 is mounted, including a re-infusion clamp 60, a blood clamp 62, a saline clamp 64, and a plasma clamp 66. The re-infusion clamp 60 is used during the collection phase ( Figure 5 ) is closed to block the reinfusion line (42) and during the reinfusion phase ( Figure 6 ) is opened to allow the blood pump to reinfuse the concentrated cellular component from the reservoir 32 to the donor. The blood clamp 62 is opened during the collection phase to allow anticoagulated whole blood to be pumped to the separator 14 and is closed during the reinfuse phase to occlude the blood line 38. The saline clamp 64 is closed to occlude the saline line 46 during the collection phase and during the reinfuse of the separated cellular component. If saline is used as the replacement fluid, the saline clamp 64 is opened during the reinfuse phase. The plasma clamp 66 is opened during the collection phase to allow plasma to flow into the plasma collection container 28 and is closed during the reinfuse phase.

[0053] The hardware component 10 includes three weight 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.

[0054] The donor remains connected to the system throughout the entire process. As shown, the disposable kit 12 includes a single venipuncture needle 36 that is inserted during the collection phase ( Figure 5 ) whole blood is drawn from the donor through the venipuncture needle 36 and during the re-infusion phase ( Figure 6 ) The concentrated cells are returned to the donor through the venipuncture needle 36. As mentioned above, the plasmapheresis process can include multiple cycles, each cycle having a collection / separation phase followed by a return or re-infusion 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 re-infusion phase, the concentrated cells from the reservoir 32 are re-infused into the donor through the venipuncture needle 36. Typically, plasmapheresis using a single venipuncture needle 36 involves multiple collection and re-infusion cycles.

[0055] Back to Figure 5 During the collection phase, an anticoagulant solution (AC) is pumped at a controlled rate and mixed with the whole blood as it enters the disposable set 12. The anticoagulated blood is pumped to the separator 14 where the plasma is separated from the cellular components and directed to the plasma collection container 28.

[0056] The cellular components are pumped from the separator 14 to the reservoir 32. When the reservoir 32 reaches the desired volume of concentrated cells or if the targeted plasma collection volume has been reached, the collection phase stops.

[0057] Then, the infusion phase begins. Figure 6 During the re-infusion phase, blood pump 56 reverses direction and pumps concentrated cells from reservoir 32 back to the donor through apheresis needle 36. If a saline regimen was selected, according to which saline is returned to the donor as a replacement fluid for the collected plasma, a saline infusion is performed after the final re-infusion phase.

[0058] According to one aspect of the present disclosure, an automated plasma collection device is configured to collect a volume / weight of anticoagulated plasma (i.e., a plasma product) having the maximum volume / weight of raw plasma allowed by a donor under the restrictions given in the FDA nomogram. In order to maximize the volume of raw plasma containing the plasma product, the device is programmed using a nomogram that takes into account the donor's hematocrit. Given the donor's hematocrit and the AC ratio of the instrument, the total volume / weight of the plasma product to be collected can be determined so that the plasma product includes a maximum volume / weight of plasma raw material portion that can be collected from the donor consistent with the restrictions on the total volume / weight of raw plasma given in the FDA nomogram. By programming the algorithm into the controller, the possibility of operator error is reduced compared to calculating the collection volume offline and then entering the collection volume into the instrument.

[0059] During plasmapheresis, when the anticoagulant is mixed with the whole blood while it is being drawn from the donor, the anticoagulant is evenly distributed in the raw plasma in the blood. However, the amount of raw plasma in the whole blood depends on the hematocrit Hct of the whole blood. The following relationship is established:

[0060] The volume of RBC = the volume of whole blood * Hct / 100. [1]

[0061] The volume of raw plasma = the volume of whole blood * (1-Hct / 100). [2]

[0062] When the anticoagulant is mixed with whole blood, the anticoagulant is typically dosed at an AC ratio ACR of 16 parts whole blood to 1 part AC or 1 part whole blood to 0.06 parts AC.

[0063] ACR = volume of whole blood / volume of anticoagulant (donor blood does not contain anticoagulant). [3]

[0064] (This produces slightly different results than the FDA nomogram, which, as mentioned above, standardizes the volume of anticoagulant that can be added to a ratio of 1:16 anticoagulant to anticoagulated blood, or 0.06 parts anticoagulant to 1 part anticoagulated blood.)

[0065] The volume of anticoagulated blood = the volume of anticoagulant + the volume of whole blood. [4]

[0066] Combining the equations, we get:

[0067] The volume of raw plasma = ACR * the volume of anticoagulant * (1-Hct / 100). [5]

[0068] As red blood cells are returned to the donor:

[0069] The volume of collected plasma = the volume of raw plasma + the volume of anticoagulant. [6]

[0070] Equation [5] and Equation [6] can be combined to calculate the amount of anticoagulant in a given amount of collected plasma:

[0071] Anticoagulant volume = collected plasma volume / (1+ACR*(1-Hct / 100)). [7]

[0072] also:

[0073] The volume of collected plasma = the volume of raw plasma * K, where K = (ACR * (1-Hct / 100) + 1) / (ACR * (1-Hct / 100)). [8]

[0074] Given the relationship expressed in the above equation, the volume of raw plasma contained in a plasma product of a volume permitted under the FDA nomogram can be determined based on the donor's hematocrit. The result of this calculation is Figure 7 Given in Figure 7 The volume of raw plasma contained within the plasma product volume limits set by the FDA nomogram based on donor hematocrit is shown.

[0075] As reference Figure 7 It will be appreciated that for donors weighing from 110 pounds to 149 pounds (for which the maximum plasma product volume according to the FDA nomogram is 690 mL), if the donor's hematocrit is 42 or greater, the volume of raw plasma collected is less than the 625 mL allowed by the FDA nomogram. The situation is similar for donors weighing from 150 pounds to 174 pounds (for which the maximum plasma collection volume according to the FDA nomogram is 825 mL) and for donors weighing over 175 pounds (for which the maximum plasma collection volume according to the FDA nomogram is 880 mL) when the donor's hematocrit is 40 or greater.

[0076] Figure 8 The table given in Figure 7 The difference between the value given in and the maximum volume of raw plasma that can be collected based on the FDA nomogram represents the volume of “unclaimed” raw plasma in the plasma product. Fig. 9 As shown in the table given in , plasma products collected from any particular donor can be adjusted for plasma products given in the FDA nomogram in the following amounts: Figure 8 The amount of "unrequired" starting plasma given in corresponds to the amount of anticoagulant required to process the additional volume.

[0077] Alternatively, the volume of plasma product to be collected can be calculated by the following steps: first, determine the weight and hematocrit (Hct) of the donor; based on the weight (Wkg ) Determine the raw plasma (V RP ) volume; V is determined based on the anticoagulant ratio (ACR; 1:16 or 0.06:1 according to the FDA nomogram) and the donor’s Hct PP With V RP The ratio K between them makes K = V PP / V RP ; and determine V PP , so that V PP =V RP * K. In addition, K = (ACR*(1-Hct / 100)+1) / (ACR*(1-Hct / 100)).

[0078] In another alternative, the volume of plasma product to be collected (V PP ): First, determine the weight of the donor (W kg ) and hematocrit (Hct); based on the donor's weight (W kg ) Determine the raw plasma (V RP The volume of anticoagulant to be added (V AC ), so that V AC =V RP *(ACR*(1-Hct / 100)); and determine the collection volume so that V PP =V RP +V AC .

[0079] Various methods can be used to determine the volume of raw plasma that can be collected based on the weight of the donor. For example, the weight of the donor can be multiplied by an established constant "K1" (e.g., 10 mL / kg). Alternatively, the weight of the donor can be divided into weight categories and a fixed volume can be established for each category (as in the FDA nomogram discussed above, in which the range of donor weights is divided into three categories).

[0080] Alternatively, the plasma volume of the donor can be estimated based on the total blood volume of the donor, and a certain volume of plasma consistent with the safety and comfort of the donor can be obtained based on the estimation. The total blood volume of the donor can be estimated using methods that utilize donor parameters. Examples of such methods include the Nadler equation (which takes into account the height, sex, and weight of the donor), the Gilcher five-point method (which takes into account sex, weight, and body type (obese, thin, normal, or robust)), or the International Council for Standardization of Hematology ("ICSH") as given in Br. J. Haem. 1995, 89: 748-56 (which takes into account the height, weight, age, and sex of the donor). Any other generally accepted method can also be used to determine the total blood volume of the donor. Any other generally accepted method for determining the total blood volume of a donor may also be used, such as the method disclosed in "Estimating Blood Volume in Obese and Morbidly Obese Patients" by Lemmens et al., Obesity Surgery, 16, 773-776, 2006:

[0081]

[0082] in, In Bv is the indexed blood volume, and BMI p is the patient's body mass index based on the patient's weight and height. Age-dependent regression equations can also be used to index blood volume to IBW (ideal body mass) In BV, as shown below:

[0083] In BV = 90-0.4X age (male); In BV = 85 - 0.4 X age (female). Therefore, the indexed blood volume can be calculated based on the gender of the donor.

[0084] 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).

[0085] Based on an analysis of demographic, examination, and laboratory data from the 2015-2016 National Health and Nutrition Examination Survey, in which sex, age, height, weight, gestational data, and hematocrit were extracted and presented in Pearson et al., Interpretation of measured red cell mass and plasma volume in adults: Expert Panel on Radionuclides of the International Council for Standardization in Haematology, British J. Haematology, 89:748-756 (1995), from which the ICSH-recommended formula was derived, it has been determined that for donors with certain characteristics (i.e., low-weight females with high hematocrits), up to 36% of usable plasma can be collected while complying with current regulations. Plasmapheresis procedures for such donors have been routinely performed without adverse reactions and are therefore considered safe. This suggests that up to 36% of a donor's usable plasma can be safely collected during the plasmapheresis process.

[0086] Considering that only negative deviations of the donor's actual blood volume from the predicted / calculated total blood volume pose a potential risk, it would be appropriate to further adjust the available volume of plasma downward. Based on consideration of the deviations between the calculated blood volume determined by Pearson et al., as cited above, and the experimental blood volume data presented in Retzlaff et al., 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 predicted blood volume of an individual will not differ by more than 20.5%. Therefore, the above-described 36% available raw plasma volume of the donor's total plasma volume can be determined using a scaling factor of 0.795, so that 28.6% of the donor's calculated volume of raw plasma can be obtained consistent with the safety and comfort of the donor.

[0087] Alternatively, the volume V of available plasma can be calculated RP The volume V of whole blood calculated previously WB Adjust V C , so, V RP =0.36(1-Hct)(V WB -V C ). A regression analysis was performed on the data provided by Retzlaff, and the results determined that V C =523mL.

[0088] Thus, the collection volume (volume of plasma product) is determined based on the volume of raw plasma that can be collected from a particular donor, the donor's hematocrit, and a fixed anticoagulant ratio (ACR). Thus, this method allows for more consistent control of a donor's raw plasma volume, which is the variable most relevant to donor safety.

[0089] In practice, the operator inputs into the system controller a collection volume for a particular donor's plasma product based on a target volume of raw plasma that can be obtained. The target plasma collection volume can be based on the donor's weight and hematocrit during the initial collection phase or by any of the other methods given above. Fig. 9 Alternatively, the controller is configured to calculate the target plasma product collection volume according to methods such as those described above, when the operator enters, for the initial collection phase, information such as the donor's weight and hematocrit and / or any additional donor-specific information (e.g., the donor's gender, height, and age) as required by the methods used to determine the donor's total blood volume, total plasma volume, and target volume of available plasma that can be collected. In another alternative, the plasma collection device can be integrated with a donor management system, and donor parameters used for qualification screening (e.g., weight, hematocrit, etc.) can be sent electronically to the instrument by the donor management system, thereby eliminating the opportunity for operator error in entering 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 will be transmitted to the controller of the plasma removal device. All types of parameters (e.g., weight, height, gender, hematocrit, name, date of birth, target volume of plasma product, target volume of raw plasma, anticoagulant ratio, collection type, blood components to be collected, etc.) can be retrieved by the controller 50 of the hardware 10 from another database (e.g., a central or remote database) that may be remote from the hardware component 10, for example using the database referred to herein. Fig.13 and Fig.14The remote database may be a donor management system, such as a donor management system used for pre-donation donor screening, donor recruitment, and / or donor record management. The controller 50 may be configured to retrieve or download parameters from the remote database via one or more wired and / or wireless networks, such as a local area network, a wide area network, an Ethernet, a Wi-Fi network using the IEEE 802.11x standard, or other networks.

[0090] As mentioned above, the plasmapheresis process is performed in multiple cycles of a collection / aspiration phase and a return / reinfusion phase. If the return / reinfusion phase does not include reinfusion of a replacement fluid, the donor's hematocrit will increase from one cycle to the next. Therefore, if the target volume of the plasma product is determined based solely on the donor's initial hematocrit without taking into account the increase in the donor's hematocrit, the volume of anticoagulant in the plasma product will be larger (and the volume of raw plasma will be smaller) than predicted by the preliminary calculation used to determine the target volume of the plasma product. Therefore, in order to ensure that the volume of the collected plasma product contains 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 plasmapheresis process, such as before the start of the collection phase of each cycle, to take into account changes in the donor's hematocrit.

[0091] Therefore, the target volume of the plasma product is determined based on the donor's initial hematocrit. The plasma removal process starts from the first suction stage until a specified volume of whole blood (usually about 500mL) has been extracted from the donor. Anticoagulant is added to the whole blood, and the anticoagulated whole blood is separated into plasma products, red blood cells and other non-RBC blood components. At the end of the first suction stage, red blood cells and non-RBC blood components are returned to the donor. The current volume of the plasma product collected after the first suction stage is determined, for example, by a weight scale. Then, the current value of the donor's hematocrit is established, and the new target volume of the plasma product to be collected is determined, and the second cycle of the extraction stage and the return stage is performed. The cycle of the suction stage and the return stage is repeated until the plasma product of the target volume recalculated before each suction stage is collected for the plasma removal process. After the last collection stage, the controller starts the last red blood cell reinfusion stage, after which the donor is disconnected.

[0092] Reference Fig.10 and Fig.11a , Fig.11b From the table, it can be seen the benefits of performing a plasmapheresis process with multiple collection / reinfusion cycles according to the method given above. Fig.10Input data for a hypothetical plasmapheresis procedure for a donor weighing 190 pounds (86.4 kg) and having an initial hematocrit of 44 is shown. Figure 1 The simplified FDA nomogram limits the volume of plasma to be collected from such donors to 800 mL and the total collected volume of plasma product to 880 mL. In this example, the FDA nomogram limits the volume of raw plasma that can be collected 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 that is different from the amount indicated by the FDA nomogram.

[0093] The number of collection and reinfusion cycles in a plasmapheresis procedure may range from three to twelve. In a hypothetical plasmapheresis procedure, there are five collection and reinfusion cycles, which are selected for illustration purposes.

[0094] Before the first collection cycle begins, the volume of raw plasma to be collected and the total target volume of the plasma product to be collected are determined according to the method described above based on the donor's initial hematocrit. As given in the first row of the table (Cycle 1 Start), the initial target volume of the plasma product to be collected is 889 mL, which is consistent with the Fig. 9 The form is the same as that indicated for a donor weighing over 175 pounds and with a hematocrit of 44 in order to obtain the FDA-limited 800 mL of raw plasma from the donor.

[0095] During each collection phase, 500 mL of whole blood is drawn from the donor and anticoagulant is added to the whole blood at a predetermined ratio (ie, 1:16) such that 31 mL is added for each collection cycle of 500 mL. The whole blood plus anticoagulant is separated into a plasma portion and a red blood cell portion.

[0096] During the first return phase (end of cycle 1 return), red blood cells and "non-RBC" blood components are returned to the donor, causing the donor's hematocrit to increase to 45.6% at the end of the first return cycle, which 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 beginning of the plasmapheresis process. When determining the new hematocrit value for the next cycle, the controller may also take into account the volume of anticoagulant reinfused with the red blood cells during each return phase and the residual anticoagulant in the donor's whole blood drawn in cycle 2 and beyond. The raw plasma volume to be collected for the process and the total target volume of plasma product are then recalculated based on the donor's raw plasma volume and the new increased hematocrit. This provides a new target collection volume of 891 mL.

[0097] A second collection phase was then performed, resulting in a total of 430 mL of plasma product containing 386 mL of raw plasma collected in the first two collection phases (end of cycle 2 aspiration). The red blood cells and "non-RBC" blood components were again returned to the donor, after which the donor's hematocrit was calculated to be 47.2%.

[0098] Two more 500 mL collection phases are performed, each followed by a return phase, wherein new values ​​for the volume of raw plasma to be collected and the total volume of the plasma product are determined before the start of each collection phase. As the donor's hematocrit increases, the target collection volume recalculated for the process increases to 893 mL (for the third collection phase) and then to 894 mL (for the fourth collection phase). A fifth "micro" collection cycle is performed to bring the volume of raw plasma collected to 800 mL allowed by the FDA nomogram for the hypothetical donor. The recalculated target collection volume of the plasma product for the fifth collection phase remains at 894 mL.

[0099] Therefore, as shown in the above example, 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 based solely on the donor's initial hematocrit, 889 mL of plasma product will be collected; or if the target collection volume is based on the simplified FDA nomogram, 880 mL of plasma product will be collected. In both cases, less than the target volume of 800 mL will be collected.

[0100] As can be appreciated, the more accurately the donor's hematocrit can be determined before and during the process, the more likely it is that the target volume of plasma product collected will include the maximum volume of raw plasma that can be collected for a particular donor. As described above, the donor's hematocrit during the process is based on the assumption that 100% of the red blood cells extracted in each aspiration cycle are reinfused in each return cycle along with 100% of the non-RBC cell products and a certain volume of anticoagulant. However, it has been determined that during the blood separation process, interstitial fluid shifts to the intravascular space, thereby restoring half of the extracted volume. See Saito et al., Interstitial fluid shifts to plasma compartment during blood donation, Transfusion 2013; 53(11): 2744-50. At each return stage, in addition to the red blood cells, non-RBC cell products and anticoagulants, the transferred interstitial fluid is also reinfused. Therefore, accounting for the transfer of interstitial fluid will lead to a more accurate determination of the hematocrit and, therefore, a more precise determination of the target volume of the plasma product, which will yield the maximum amount of starting plasma.

[0101] The transfer of interstitial fluid during plasma extraction has been demonstrated by tracking the level of immunoglobulin G (IgG) of the donor during plasma extraction. See, for example, Burkhardt et al., published in Transfusion (blood transfusion) 2017; 56: 417-420, Immunoglobulin G levels during collection of large volume plasma for fractionation. If there is no interstitial fluid transfer, the IgG level of the donor will remain stable during plasma extraction. However, IgG levels have been shown to decrease, and the amount of IgG level decrease is a function of the volume of interstitial fluid that has been transferred to the blood system.

[0102] Reference Fig.12, shows a plot of the volume of collected plasma (along the X-axis) versus the IgG concentration (along the Y-axis) formed experimentally. It can be seen that from a baseline of zero collected plasma (at the beginning of the process) to 200 mL of collected plasma, the donor's IgG dropped by 9%, and from 200 mL of collected plasma to 800 mL of collected plasma, the donor's IgG dropped by another 4%. This can be attributed to the transfer of interstitial fluid equal to 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).

[0103] based on Fig.12 The following relationship between the donor's IgG concentration and the volume of collected plasma has been established: y = 1.0017x -0.02 , where y = IgG concentration and x = plasma volume collected. Therefore, the proportion of the donor's blood volume replaced by transfer of interstitial fluid is equal to V b (1-y), where V b is the initial volume of the donor's whole blood. Thus, the transferred volume of interstitial fluid can be calculated based on the volume of collected plasma, and this amount can be added to the volume of red blood cells, non-RBC cell products, and anticoagulants reinfused in each return phase to determine the donor's current total blood volume and therefore the hematocrit. As can be appreciated, the controller can be configured to automatically determine the volume of interstitial fluid that has been transferred based on the volume of collected plasma, and include this transferred volume when determining the donor's hematocrit prior to each aspiration phase.

[0104] Alternatively, other methods of directly measuring the donor's hematocrit may be employed such as optical sensors, or, if a centrifuge is used, measuring the volume of red blood cells in the centrifuge.

[0105] Additionally, anticoagulant is typically introduced into the disposable set in a pre-processing step prior to the start of the plasmapheresis process, such as for priming the disposable set, performing one or more pre-cycles, or for performing other pre-process steps. To the extent that the anticoagulant used for these purposes will ultimately be directed to the plasma product collection container, the anticoagulant used for these purposes can be taken into account when determining the volume contained in the plasma collection container that results in a target volume of collected raw plasma. For example, this can be accomplished by measuring the weight of the container "full" of anticoagulant and the weight of the container of anticoagulant before the start of the first aspiration cycle 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.

[0106] The method and system described above have several aspects. In a first aspect, a method for collecting plasma is provided, wherein a plasma product is collected in multiple collection stages, between which separated red blood cells are reinfused into a donor. The method of the first aspect comprises: a) determining a volume (V b ) and hematocrit (Hct); b) determine the volume of raw plasma that can be collected from the donor (V RP ); c) determine the volume of plasma product that can be collected (V PP ), wherein the plasma product comprises the volume of raw plasma plus the volume of anticoagulant; d) drawing whole blood from a donor; e) introducing the anticoagulant into the drawn whole blood at a specific ratio (ACR); f) separating the drawn whole blood into a plasma product and a second component comprising 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 Hct and V of the donor prior to each collection stage PP .

[0107] In a second aspect, steps d) to i) are continued until the measured volume of the plasma product in the collection container is equal to V PP until.

[0108] In a third aspect, a method for collecting plasma is provided, wherein the plasma product is collected in multiple collection stages, and between the multiple collection stages, the separated red blood cells are re-infused into the donor. The method of the second aspect comprises: a) determining the volume (V) of the donor's whole blood b ) and hematocrit (Hct); b) based on V b Determine the volume of raw plasma (V) that can be collected from the donor RP ); c) determine the amount of blood to be added to V based on the anticoagulant ratio (ACR) and the Hct of the donor RP The volume of anticoagulant V AC , so that V AC =V RP *(ACR*(1-Hct)); d) Determine the volume of plasma product that can be collected (V PP ), wherein the plasma product includes the raw plasma volume (V RP ) The volume of anticoagulant added (V AC ); e) drawing whole blood from a donor; f) introducing an anticoagulant at a specific ratio (ACR) into the drawn whole blood; g) separating the drawn whole blood into a plasma product and a second component comprising red blood cells; h) collecting the plasma product in a plasma collection container; i) returning the red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and j) determining the donor's Hct and V prior to each collection stage. PP .

[0109] In a fourth aspect, steps d) to j) are continued until the measured volume of the plasma product in the collection container is equal to V PP until.

[0110] In the fifth aspect, V b The determination is based on one or more donor-specific characteristics including the donor's weight, height, sex, age, and body shape.

[0111] In a sixth aspect, a method for collecting a certain volume (V PP ) of the present invention, wherein the plasma product is collected in multiple collection stages, and the separated red blood cells are re-infused into the donor between the multiple collection stages. In the method of the fourth aspect, V PP Equal to the volume of raw plasma that can be collected from the donor (V RP ) is added to V during the apheresis process RP Anticoagulants (V AC The method comprises the following steps: a) determining the weight of the donor (W kg ) and gender (M or F); b) determine the donor's hematocrit (Hct); c) based on the donor's weight (W kg ) and gender (M or F) determine the volume of raw plasma that can be collected V 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 , so that V PP =V RP *K; f) draw whole blood from a donor; g) introduce an anticoagulant at a specific ratio (ACR) into the drawn whole blood; h) separate the drawn whole blood into a plasma product and a second component comprising red blood cells; i) collect the plasma product 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 prior to each collection stage PP .

[0112] In a seventh aspect, steps c) to k) are repeated until the measured volume of the plasma product in the collection container is equal to V PP Preferably, K = V PP / V RP =(ACR*(1-Hct / 100)+1) / (ACR*(1-HCT / 100)).

[0113] In an eighth aspect, a method for collecting a certain volume (V) during apheresis is provided. PP ) of a plasma product, wherein the plasma product is collected in multiple collection stages, and between the multiple collection stages, the separated red blood cells are re-infused into the donor. In this fifth aspect, V PP Equal to the volume of raw plasma that can be collected from the donor (V RP ) is added to V during the apheresis process RP The volume of anticoagulant (V AC The method comprises the following steps: a) determining the weight of the donor (W kg ) and gender (M or F); b) determine the donor's hematocrit (Hct); c) based on the donor's weight (W kg ) and the gender of the donor (M or F) determine the volume of raw plasma that can be collected (V RP d) determine the amount of blood to be added to V based on the anticoagulant ratio (ACR) and the Hct of the donor RP V AC , so that V AC =V RP *(ACR*(1-Hct)); e) determine V PP , so that V PP =V RP +V AC ; f) drawing whole blood from a donor; g) introducing an anticoagulant at a specific ratio (ACR) into the drawn whole blood; h) separating the drawn whole blood into a plasma product and a second component comprising red blood cells; i) collecting the plasma product in a plasma collection container; j) returning the red blood cells to the donor after the desired amount of whole blood has been drawn from the donor; and k) determining the donor's Hct and V prior to each collection stage. PP .

[0114] In the ninth aspect, steps d) to k) are continued until the measured volume of the plasma product in the collection container is equal to V PP until.

[0115] In the tenth aspect, V RP Determined by establishing V for each of a plurality of ranges of donor weight RP And select V for a weight range that includes the weight of the donor RP The donor weight ranges were divided into three categories: from 110 pounds to 149 pounds, from 150 pounds to 174 pounds, and over 175 pounds.

[0116] In the eleventh aspect, V RP =K1*W kg .

[0117] In the twelfth aspect, VRP Not more than (1-Hct)*(V b )’s 28.6%.

[0118] In the thirteenth aspect, V b It is determined using one of the Nadler equation, Gilcher's quintile, ICSH's criteria, and any other generally accepted method.

[0119] In the fourteenth aspect, V RP =W kg *10mL / kg.

[0120] In a fifteenth aspect, in using donor parameters to estimate the total blood volume (V b ), V RP =K2*V b .

[0121] In a sixteenth 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 also includes: i) a separator for separating whole blood into a plasma portion and a concentrated cell portion, 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 conveying whole blood from a donor to the separator, the plasma output port being integrally connected to a plasma collection container via a plasma line, the concentrated cell outlet port being integrally connected to a reservoir for receiving concentrated cells prior to reinfusion into the donor; ii) a donor line terminating in a venipuncture needle, the donor line being used to convey whole blood from a donor to the blood line; iii) an anticoagulant line integrally connected to the blood line and configured to be connected to a source of anticoagulant, the anticoagulant line being used to convey anticoagulant to the donor line; iv) a saline line configured to be attached to a source of saline, the saline line being used to convey saline to the blood line; and v) a reinfusion line for conveying concentrated cells from the reservoir to the donor line. The reusable hardware components also include: i) a peristaltic first pump for delivering anticoagulant to the blood line at a controlled rate during the collection phase; ii) a second pump for delivering anticoagulated whole blood to a separator during the collection phase and returning the concentrated cell component during the re-infusion phase; iii) a third pump for delivering the concentrated cell component from the separator to a reservoir during the collection phase; iv) a clamp associated with each of the blood line, the plasma line, the re-infusion line, and the saline line; v) a weight scale for weighing each of the plasma collection container, the reservoir, and the anticoagulant source; and vi) a programmable controller including a touch screen for receiving input from an operator, the programmable controller being configured to receive signals from each weight scale and automatically operate the first pump, the second pump, and the third pump and the clamp to separate whole blood into a plasma portion and a concentrated cell portion during the collection phase and to return the concentrated cells to the donor during the re-infusion phase. The programmable controller is also configured to determine the weight of the plasma portion 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 weight scale regarding the plasma collection container that is equal to the weight of the plasma component determined by the controller. When determining the target amount of plasma product to be collected, the controller can be configured to calculate the donor's hematocrit prior to the collection phase of each cycle. Alternatively or additionally, the controller can receive a signal from a sensor or the like indicating the donor's hematocrit. In addition, the amount of plasma product in the plasma collection container can be determined by, for example, a weight scale associated with the plasma collection. In one embodiment, the separator includes a rotating diaphragm separator.

[0122] Fig.13A system 110 for performing a medical procedure on a recipient is illustrated. Fig.13 and Fig.14 One or more features, functions or components of the embodiments may be combined with Figures 1 to 12 One or more features, functions, or components of the embodiments may be combined to provide other embodiments. Fig.13 The system 110 includes a data storage location (e.g., a database 112), a user interface 114, a processing device 116, and a controller 118. The system can be configured and used to perform any particular medical procedure. More specifically, the system can be configured to perform an automated or semi-automated apheresis procedure or blood collection procedure, such as the plasmapheresis procedure described above, on a healthy donor or patient.

[0123] The data storage location may be configured and positioned differently without departing from the scope of the present disclosure. For example, the data storage location may be integrated into the system 110 and associated with the controller 118, such as having Fig.13 In other embodiments, the data storage location may be remote from the system 110, for example, at or in a central server or storage facility of the owner of the system 110. If the data storage location is remotely located, it may communicate with the system 110 via any of a variety of known or novel remote access means, such as, but not limited to, wireless Internet access. In another embodiment, the data storage location is a removable storage device, such as an encoded identification card, which can be associated with the system 110 by a recipient or operator. Other configurations of data storage locations may also be employed without departing from the scope of the present disclosure.

[0124] Data storage locations can store a variety of data and information. Fig.13 In an embodiment of the present invention, a data storage location (in the form of a database 112) stores one or more recipient data entries 120, wherein each recipient data entry 120 corresponds to a recipient (i.e., a donor or patient) for whom a medical procedure will be performed using the system 110. At some time before the system 110 performs a medical procedure on a particular recipient, the database 112 is preprogrammed with recipient data entries 120 for a particular recipient. Each recipient data entry 120 includes recipient-specific information 122, such as name, weight, sex, age, date of birth, address, unique password, fingerprint, facial or retinal data, and / or answers to security questions. The recipient-specific information 122 corresponds to the identity of the recipient and is compared to an identity input 126 entered into the system by the recipient, as will be described in more detail below.

[0125] In addition to the recipient-specific information 122, each recipient data entry 120 may include one or more parameters 124, or the controller 118 may calculate or determine these parameters based on the medical procedure and / or a combination of the procedure and the recipient-specific information 122. The nature of the parameters 124 may vary depending on the nature of the medical procedure to be performed. In addition, the parameters 124 may be related to or derived based on the following: the gender of the recipient, the weight of the recipient, the acceptable rate of fluid aspirated from the recipient and / or returned to the recipient (e.g., citrate infusion rate), etc.

[0126] The user interface 114 includes a display for receiving commands and information from an operator or recipient and displaying instructions for the operator or recipient to execute. The display can be provided in different ways, such as in the form of a touch screen, or alternatively, in the form of a screen with associated devices that allow the operator or recipient to interact with the user interface 114 (e.g., a keypad or keyboard). The user interface 114 also includes an input device for receiving an identity input 126 from the recipient, which corresponds to the identity of the recipient. As will be described in more detail below, there are multiple ways for the recipient to identify him or herself, so the input device can be configured differently. In some embodiments, the display is used as an input device, while in other embodiments, the input device is separated from the display.

[0127] The principles of the present disclosure may be employed in a variety of devices and in a variety of procedures. Thus, the processing device 116 that actually performs the medical procedure (at least a portion of the medical procedure) on the recipient may be configured differently. In one embodiment, the processing device 116 may be an apheresis system, such as a centrifuge system, which is configured to draw blood from the recipient, separate the blood into its components, and return at least one of the components to the recipient. Exemplary centrifuge systems include those currently sold by Fenwal Corporation of Lake Zurich, Illinois. System and Systems, both of which are described in more detail in U.S. Pat. No. 6,325,775 and U.S. Pat. No. 5,868,696, which are incorporated herein by reference. Other treatment devices may also be employed without departing from the scope of the present disclosure, including (but not limited to) dialysis systems, parenteral nutrition systems, and other systems.

[0128] The controller 118 is associated with or in communication with the database 112, the user interface 114, and the processing device 116. The controller 118 may be configured or programmed with a plurality of functions or programs and has various functions, including (but not limited to) receiving data from various other components of the system 110, issuing commands to various other components of the system 110, and monitoring the performance of various other components of the system 110. In one embodiment, the controller 118 is configured to compare the identity input 126 provided by the recipient with the recipient data entries 120 stored in the database 112. If the identity input 126 corresponds to the recipient-specific information 122 stored in one of the recipient data entries 120 (i.e., if the system 110 "recognizes" the recipient), the controller 118 will command the processing device 116 to perform a medical procedure on the recipient. This may include determining or accessing parameters 124 associated with a particular recipient data entry 120 (if provided), and sending the parameters 124 to the processing device 116 for use in performing the medical procedure.

[0129] If the identity input 126 does not correspond to the recipient-specific information 122 stored in any of the recipient data entries 120, the controller 118 can initiate any of a number of responses. In one embodiment, the controller 118 generates an error signal that prevents the medical procedure from being performed on the recipient. The error signal can trigger an audible and / or visual alarm and warning, including commanding the user interface 114 to show an error message on a display (e.g., "Unable to confirm individual"). In another embodiment, the controller 118 optionally commands the processing device 116 to perform the procedure on the recipient using default operating parameters rather than parameters uniquely suited to the recipient.

[0130] Fig.14 An exemplary manner of using a system 110 according to the present disclosure is illustrated. Prior to performing a medical procedure on a recipient, recipient data entries 120 are preprogrammed into a database 112 for the recipient. This can be done remotely or by using a user interface 114. The medical personnel is prompted to enter various information including at least recipient-specific information 122 that will be used to identify the recipient. The medical personnel may also be prompted to enter one or more parameters 124 to be used when performing the medical procedure on the recipient. Depending on the nature of the identity input 126, the nature of the recipient-specific information 122 and therefore the manner and form in which it is entered into the database 112 may vary. For example, the information may be retrieved from another database, such as a central database or a remote database, by direct query and download, or in response to input by the recipient or medical personnel. The remote database may be a remote database such as that described herein with reference to FIG. Figures 1 to 12 The donor management system described in the embodiments of the present invention can be retrieved from a remote database for information or parameters to be used as described herein. Figures 1 to 12The plasma collection process described herein. In addition, the nature of the parameter(s) 124 may depend on the nature of the medical procedure being performed on the recipient. When the recipient-specific information 122 and optional parameters 124 (if provided) have been entered into the system 110, medical personnel may confirm the entered data, thereby generating a recipient data entry 20 that is stored in the database 112 and is unique to the recipient.

[0131] At some later time, the recipient is brought into proximity or proximity of the system 110 or an operable portion of the system 110. The recipient may connect to the processing device 116 when brought into proximity of the system 110, or may connect to the processing device 116 at a later time (e.g., after the system 110 has confirmed the recipient's identity). While in proximity of the system 110, the recipient attempts to identify himself or herself to the system 110 by providing identity input 126 via an input device of the user interface 114. The identity of the recipient may be expressed in any of a variety of ways, and thus the system 110 may include one or more different input devices for receiving the identity input 126.

[0132] In one embodiment, the identity input 126 may take the form of biometric data, in which case the input device of the user interface 114 is configured as a biometric scanner or reader. For example, the input device may be configured as a fingerprint reader to receive and analyze the recipient's fingerprint. In another embodiment, the input device is configured as a retinal scanner to observe and analyze the recipient's retina. In yet another embodiment, the input device includes facial recognition software to observe and analyze the recipient's face. In another embodiment, the input device is configured as a heart rate monitor to take into account the recipient's heart rate. In yet another embodiment, the input device includes a microphone or similar audio device to receive and analyze the recipient's voice. In another embodiment, the input device is configured to receive a blood sample from the recipient and analyze the recipient's DNA. The recipient may also (or additionally) provide other biometric identifiers to express his or her identity.

[0133] In another embodiment, the recipient is provided with a unique recipient identification card, badge, or removable storage device, which the input device analyzes in an attempt to identify the recipient to the system 110. For example, the input device may include a barcode reader, and the recipient is provided with a recipient identification card having personal information encoded into a barcode that can be read by the input device. In another example, the recipient may have a recipient identification card that is encoded with personal information and has built-in radio frequency identification ("RFID") circuitry. The input device includes an RFID reader that is capable of reading the personal information on the card for subsequent analysis by the controller 118. As described above, the card can be used as a data storage location, further encoded with one or more of the recipient's unique operating parameters 124, rather than having the parameter(s) 124 preprogrammed into the database 112 or derived / calculated by the controller 118. In this case, the identity input 126 and parameter(s) 124 (if any) will be read by the input device, and if the identity input 126 corresponds to the recipient specific information 122 in one or more of the recipient data entries 120, the controller 118 will send the parameter(s) 124 from the card to the processing device 116. In addition, the card can be encoded with multiple processing schemes, with the system 110 tracking the results of each processing over time.

[0134] In one or more embodiments, the controller 118 may be programmed to require that one or more of the recipient-specific information 122 in the recipient data entry 120 correspond to the identity input 126. For example, the system 110 may require a combination of the correct recipient-specific information 122 before performing a medical procedure. Specifically, the system 110 may require that two or more of the recipient-specific information 122 be consistent with the identity input 126 and / or consistent with each other. As non-limiting examples, the system 110 may require consistency in: name and gender; name and password; name, fingerprint, and medical condition; fingerprint and facial recognition; or other combinations as may be selected.

[0135] In yet another embodiment, the input device of the user interface 114 is programmed to recognize and read authentication software running on an electronic device (eg, a mobile phone or laptop computer).

[0136] In another embodiment, the user interface 114 is programmed to receive a personal identification number, code, or password from the recipient. If the display of the user interface 114 is a touch screen, the personal identification number can be directly entered using the display (thereby allowing the display to be used as an input device). Alternatively, an input device including a keypad or keyboard can be provided to allow the recipient to enter a personal identification number.

[0137] When the recipient has provided the system 110 with the identity input 126, the controller 118 compares the identity input 126 with the recipient data entries 120 stored in the database 112. As described above, if the identity input 126 corresponds to the recipient-specific information 122 stored in one or more of the recipient data entries 120, the system 110 may request that the identity input 126 be matched to the recipient data entry 122. Fig.14 ) as a "yes" response to the "if-then" diamond containing the statement "the medical device confirms the authentication of the individual", the system 110 has successfully identified the recipient. The controller 118 then commands the processing device 116 to perform a medical procedure (e.g., plasma collection, red blood cell collection, etc.) on the recipient, which can include the controller 118 calculating, retrieving or accessing the parameter(s) 124 associated with the particular recipient data entry 120 and sending the parameter / parameters to the processing device 116 for use in performing the medical procedure.

[0138] If the controller 118 is unable to match the identity input 126 with the recipient specific information 122 stored in any of the recipient data entries 120 (in Fig.14 ) as a "no" response to an "if-then" diamond containing the statement "the medical device confirms the individual's authentication", then the system 110 has failed to identify the recipient. Fig.14 In an embodiment, the controller 118 responds by prohibiting or refusing to proceed with the medical procedure and may generate a signal that prevents the medical procedure from being performed on the recipient. The recipient may then be given one or more additional opportunities to express his or her identity using the same or different identity input 126. As described above, different responses to failed identification may also be initiated without departing from the scope of the present disclosure.

[0139] Now refer to Fig.15According to an illustrative embodiment, a system and method for collecting plasma will be described. This embodiment can be implemented with one or more components or functional parts described above, such as a venipuncture needle, a blood separator, a donor line, an anticoagulant line, a pump, a touch screen, and a controller. At box 1500, the controller is programmed to receive parameters from a remote computer via a network. These parameters may include one or more of the donor parameters or operating parameters. These parameters may include one or more of the following: gender, age, height, weight, pregnancy data, hematocrit, recipient-specific information, name, date of birth, home address, unique password, fingerprint, facial or retinal data, answers to security questions, citrate infusion rate, donor image, target volume of plasma product (e.g., plasma plus anticoagulant), target volume of raw plasma, anticoagulant ratio, total blood volume of the donor, total plasma volume of the donor, parameters related to the total blood volume calculation described herein, and / or other parameters. In some embodiments, the remote computer performs the calculations described herein based on one or more of these parameters. In some implementations, the controller performs the calculations described herein based on one or more of these parameters.

[0140] At box 1502, the controller may be configured to receive user input to confirm the donor based at least in part on at least one of these parameters. For example, the controller may display parameters (e.g., donor identification code or number, name, date of birth, social security number, image, etc.) identifying the donor on a touch screen or other display, and the controller may be configured to receive confirmation input from an operator / user. The user may confirm by pressing a button labeled "Confirm" displayed on a teaching screen, by voice commands to a microphone connected to the controller, by using a keyboard, or by other user input devices. The operator may first confirm with the donor by talking to the donor, looking at the donor to confirm an image, etc., and then the operator may provide input to the controller by a suitable user input device such as a touch screen.

[0141] At block 1504, the controller can be configured to determine a target volume for the plasma product and / or raw plasma based at least in part on at least one of the parameters. As described above, the determination can be made by: receiving the target volume for the plasma product and / or raw plasma from a remote computer; calculating the target volume for the plasma product and / or raw plasma locally at the blood collection device; receiving input data from an operator from a user input device; or other determination methods. The calculations performed on the remote computer or on the local controller can be performed based on the simplified plasma volume nomogram described above by first calculating the total blood volume and / or total plasma volume of the donor as described above, or using any other calculation described herein.

[0142] At box 1506, if the operator confirms the donor, the controller can be configured to control the system to operate one or more (at least two, at least three, at least four, etc.) aspiration and return stages to draw whole blood from the donor and separate the whole blood into a plasma product and a second blood component, and return the second blood component to the donor.

[0143] The parameters received by the controller from the remote computer may include an image of the donor, the controller being programmed to display the image on the touch screen and to receive user input from the touch screen to confirm the donor. The parameters received by the controller from the remote computer may include a donor identifier, wherein the system further comprises a scanner configured to scan a code associated with the donor. The scanner may be a barcode scanner, a camera, or other scanning device. The controller and / or the scanner may be configured to receive scan data from the scanner from a wristband of the donor.

[0144] The parameters received by the controller from the remote computer may include at least one data unique or specific to the donor, such as a social security number, date of birth, image, etc. The controller may be configured to display at least one data unique or specific to the donor and prompt the user to confirm that the donor is associated with the data unique or specific to the donor.

[0145] In one embodiment, the remote computer is configured to calculate a target volume for the plasma product and / or source plasma based on at least two of the donor's weight, height, hematocrit, and gender.

[0146] In another embodiment, a weight scale can be used to obtain the donor weight. The weight scale can be coupled to one of the remote computer and the controller. At least one of the remote computer and the controller can be configured to receive the weight of the donor from the weight scale. The target volume of the plasma product and / or raw plasma can be determined based at least in part on the weight from the weight scale.

[0147] In one embodiment, the controller or remote computer can be configured with a camera to obtain an image of the donor. The controller or remote computer can include a processing circuit configured to use image processing techniques to determine the body mass index (BMI) of the donor. The BMI can be a parameter for calculating total blood volume. The controller or remote computer can be programmed to compare the calculated BMI with the weight and / or height entered by the operator or obtained from a weight scale. If the weight deviates from the weight expected by the calculated BMI, the controller or remote computer can be configured to generate a message for display indicating that the weight and / or height of the patient should be remeasured.

[0148] In another embodiment, parameters associated with the donor (e.g., height, weight, etc.) can be categorized in memory as constant factors (e.g., gender) or variable factors (e.g., weight, hematocrit, height). The controller or remote computer can be configured to require re-measurement or re-entry of variable factors at each donation, while constant factors do not need to be re-entered and may even be grayed out in the user input screen.

[0149] Now refer to Fig.16 , a system and method for collecting plasma (or other blood components) from a donor using a handheld computer will be described. Remote computer 1600 can be one or more computing devices configured to be used as a donor management system for managing donor data. Computer 1600 can also receive and store donor inclusion data, such as weight, height, gender, hematocrit, blood pressure, date of previous donation, and answers to donor qualification questions, to determine whether the donor is eligible to donate. Remote computer 1600 can be set away from blood processing equipment 1604, such as in another room of a blood collection facility, an off-site location, etc. Handheld computer 1602 can include a housing configured to be held in the hand during use, such as a smart phone, a personal digital assistant, a mobile phone, or other handheld device. Blood processing equipment 1604 can include a plasma removal device or other single collection device, which can be designed to collect, process and / or dispose of one or more different blood components in different modes. Each of devices 1600, 1602, and 1604 may be configured to communicate with one or two other devices via a network interface circuit configured for wired and / or wireless communication via a network, such as a local area network, a wide area network, an 802.11x or Wi-Fi network, or the like.

[0150] In one aspect, the handheld device 1602 can be configured to receive parameters from the remote computer 1600, such as a donor identifier (e.g., name, social security number, digital image, donor code, date of birth, or other data unique or specific to the donor, etc.), donor height, weight, hematocrit, gender, etc., target plasma products and / or raw plasma to be collected (as calculated by the remote computer 1600), or other parameters. One or more of these parameters can be displayed on a display of the handheld computer 1602 (e.g., a display with input and / or output capabilities, a touch screen display with input capabilities, etc.), and the operator can be prompted on the display to confirm one or more of these parameters. For example, the operator can see an image or name of the donor on the screen, as well as a prompt (e.g., text) asking the operator to confirm that the donor offering the donation is the same as the donor identified on the screen. A touch screen button can be provided for the operator to confirm the donor or other parameters or processes.

[0151] Based on the operator's confirmation (e.g., at the time of confirmation, after confirmation, or after an additional step performed after confirmation), the handheld computer 1602 can be configured to transmit or provide one or more parameters to the blood processing device 1604. For example, the parameters can be wirelessly downloaded to the blood processing device 1604. Alternatively, the parameters can be displayed on a display of the handheld computer 1602 so that the operator can see the parameters and manually enter the parameters into the blood processing device 1606 using an input device such as a touch screen.

[0152] In another embodiment, the parameters can be wirelessly transmitted directly from the remote computer 1600 to the blood processing device 1604, wherein the blood processing device 1604 waits for use, loads or starts a blood processing process based on the parameters until confirmation occurs on the handheld computer 1602 (or confirmation occurs directly on the blood processing device 1604, as described in other embodiments disclosed herein). In one example, at the same time as the donor identity data is transmitted to the handheld device 1602, the operating parameters (e.g., target plasma product and / or target raw plasma to be collected, blood components to be collected, etc.) can be transmitted to the apheresis device, and once the donor identity is confirmed, the operator can start the process on the blood processing device 1604, and the donor identity can be associated with the device parameters.

[0153] Parameters received at the handheld computer 1602 from the remote computer 1600 or from a user interface of the handheld computer 1602 may be transmitted to the blood processing system 1604 using any of a variety of techniques (e.g., wireless transmission, memory card, etc.). In one embodiment, the blood processing device 1604 includes a scanning device, such as a camera, a barcode reader, etc., configured to receive image-encoded parameters from a display of the handheld computer 1602, from paper, or from another source.

[0154] The remote computer 1600 can be configured to receive donor parameters, such as weight, height, sex, hematocrit, age, etc., and calculate a target plasma product (plasma product plus anticoagulant) and / or a target raw plasma based on these parameters and / or other parameters, such as a predetermined anticoagulant ratio. The donor parameters can be received from an operator input device, a blood establishment computer software system (BECS), or other sources. The remote computer 1600 can be configured to transmit the target plasma product and / or the target raw plasma to the handheld computer 1602 and / or the blood processing system 1604.

[0155] Some donor parameters such as donor gender may be fixed, while other donor parameters such as weight and height may be variable. Some donor parameters may be more variable than other parameters, for example, weight may be more variable than height. The system described herein (e.g., remote computer 1600, handheld computer 1602 and / or donor processing system 1604) may be configured to store donor parameters with different fixed or variable feature identifiers, wherein the system may be configured to have different requirements for these donor parameters before using the donor parameters to perform calculations and / or operations. For example, the system may be configured to calculate target plasma products and / or target raw plasma based on total body volume. Target, total body volume and / or total plasma volume may be calculated based on at least one parameter and at least one or at least two additional parameters, wherein the at least one parameter is existing data to be retrieved from a database, and the at least one or at least two additional parameters are currently obtained, measured at a predetermined time period before the donation process or within a predetermined time period. In one example, the donor height is existing data from a database, while weight and hematocrit are measured and recorded on the same day of the apheresis process. In another example, the system can be configured to use height measured and recorded at least a predetermined time period (e.g., one day, three days, etc.) prior to donation. For example, in the case of self-reporting, the system can be configured to receive height directly through the user portal of the system. The system can be configured to receive height from identification documents issued by different entities (e.g., primary care physician, another donation agency, etc.) at least three days before the procedure and record the height into a database. Various donor parameters may need to be fixed or variable in different parameters through the programming of the system.

[0156] In one embodiment, a method for collecting plasma from a donor includes: receiving parameters for a plasma collection process from a remote computer via a network at a controller local to a plasma collection device, the plasma collection device having a touch screen user input device. The method includes: receiving user input at the touch screen to confirm at least one of the process and / or parameters. The method includes: determining a target volume for a plasma product and / or raw plasma based at least in part on at least one of the parameters received from the remote computer via the network. The method includes: in response to confirmation of at least one of the process and / or parameters, controlling the plasma collection device to draw whole blood from the donor; combining an anticoagulant with the whole blood; separating the whole blood into a plasma product and a second blood component comprising red blood cells; transporting the plasma product to a plasma product collection container; and returning the second blood component to the donor.

[0157] The target volume of the plasma product and / or raw plasma may be calculated at a remote computer, wherein determining the target volume of the plasma product and / or raw plasma includes receiving the target volume of the plasma product and / or raw plasma from the remote computer at a controller.

[0158] At least one of the parameters may be a donor identifier, wherein in response to confirmation of the donor identifier, the plasma collection device is controlled to perform a plasma collection process according to the parameter.

[0159] The controller may be configured to receive user input via the touch screen to confirm the plasma collection process.

[0160] The controller may be configured to: receive the parameters; store the parameters as a configuration program in the memory; display an indication of the configuration program via the touch screen; and receive user input via the touch screen to confirm the configuration program.

[0161] It will be appreciated that the described embodiments illustrate some of the applications of the principles of the present subject matter. Many modifications may be made by those skilled in the art, including those combinations of features disclosed or claimed individually herein, without departing from the spirit and scope of the claimed subject matter. For these reasons, the scope of the claims is not limited to the above description, but is given in the appended claims.

Claims

1. A system for collecting plasma, the system 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 coupled to a plasma line configured to transport the plasma product to a plasma product collection container; a donor line fluidly configured to allow the whole blood to flow from the donor through the donor line controlled by a first pump and introduced into the separator; an anticoagulant line coupled to a source of anticoagulant, the anticoagulant line configured to combine a flow of anticoagulant with the whole blood from the donor via the anticoagulant line controlled by a second pump; a touch screen configured to receive input from an operator, the touch screen being programmed to recognize and read authentication software running on the electronic device; as well as a controller configured to control the operation of the system, the controller configured to: receive parameters for a plasma collection process from a remote computer via a network, the remote computer including a donor management system, through which donors are screened and donor records are managed prior to donation, wherein the parameters include constant donor factors and variable donor factors, wherein the controller or remote computer is configured to require re-entry of the variable donor factors at each donation, and the constant donor factors do not require re-entry, the controller further configured to: receive user input via the touch screen to confirm at least one of the process and / or the parameters; determine a target volume for a plasma product and / or raw plasma based at least in part on at least one of the parameters received from the remote computer via the network; and in response to confirming at least one of the process and / or the parameters, control the system to operate at least three aspiration and return stages to draw whole blood from a donor, separate the whole blood into the plasma product and the second blood component, and return the second blood component to the donor, wherein the controller is further configured to establish an updated value of the donor's hematocrit after controlling the system to operate the aspiration phase and the return phase and to establish a new target volume of the plasma product and / or raw plasma based on the updated value of the hematocrit, and the controller is further configured to control the system to operate subsequent aspiration and return cycles, thereby taking into account the donor's changed hematocrit when calculating the new target volume of the plasma product and / or raw plasma, Wherein, the controller is further configured to recognize an identity input of the recipient through a unique recipient identification card, and the system is configured to confirm that two or more recipient-specific information are consistent with the identity input before executing the process.

2. The system according to claim 1, wherein: The parameters include an image of the donor, and the controller is configured to display the image on the touch screen and receive the user input from the touch screen to confirm the donor.

3. The system according to claim 1, wherein: The parameters include a donor identifier, wherein the system further includes a scanner configured to scan a code associated with the donor.

4. The system according to claim 3, wherein: The scanner is configured to scan the code from a wristband worn by the donor.

5. The system according to claim 3, wherein: The parameters include at least one data that is unique or specific to the donor, wherein the controller is configured to display the at least one data that is unique to the donor and prompt the user to confirm that the donor is associated with the data that is unique to the donor.

6. The system according to claim 5, wherein: The at least one data unique or specific to the donor is a social security number or date of birth.

7. The system according to claim 1, wherein: The controller is configured to determine the target volume of the plasma product and / or raw plasma by receiving the target volume of the plasma product and / or raw plasma as one of the parameters from the remote computer.

8. The system according to claim 7, further comprising the remote computer, wherein: The remote computer is configured to calculate the target volume of the plasma product and / or source plasma based on at least two of the donor's weight, height, hematocrit, and gender.

9. The system of claim 1, further comprising the remote computer and a weight scale, the weight scale coupled to one of the remote computer and the controller, wherein: At least one of the remote computer and the controller is configured to receive the weight of the donor from the weight scale, wherein the target volume of the plasma product and / or raw plasma is determined based at least in part on the weight from the weight scale.

10. The system according to claim 1, 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 local to the blood separator and coupled to the blood separator.

11. The system according to claim 1, wherein: The donor parameters electronically received from the remote computer include donor weight, wherein the controller is configured to determine the target volume of a plasma product and / or raw plasma based at least in part on the donor weight.

12. The system according to claim 11, wherein: The donor parameters electronically received from the remote computer include a donor hematocrit, wherein the controller is configured to determine the target volume of a plasma product and / or source plasma based at least in part on the donor hematocrit.

13. The system according to claim 12, wherein: The controller is configured to determine a target volume of a plasma product based on the total blood volume of the donor and the plasma volume of the donor.

14. The system according to claim 13, wherein: The controller is configured to determine the total blood volume of the donor based on the weight and height of the donor.

15. The system of claim 14, wherein: The controller is configured to determine a total blood volume of the donor prior to drawing whole blood from the donor during a donation.

16. The system of claim 15, 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 an anticoagulant ratio, a weight of the donor, and a hematocrit of the donor before the whole blood is drawn from the donor.

17. The system of claim 1, further comprising a reservoir separate from the blood separator for receiving concentrated red blood cells.

18. The system of claim 1, wherein: The parameters received by the controller include at least the weight, height, gender and hematocrit of the donor, the controller determines the target volume of the plasma product and / or raw plasma at least partially based on the weight, height, gender and hematocrit, and the controller controls the system to operate the aspiration and return stages until the target volume is reached.

19. The system of claim 1, further comprising the remote computer, wherein: The remote computer is configured to calculate the target volume based on at least a weight, a height, a gender, and a hematocrit of a donor, wherein the controller is configured to determine the target volume by receiving the target volume from the remote computer.

20. The system of claim 1, wherein: The controller is configured to receive at least the weight, height and hematocrit of the donor and determine the target volume of the plasma product comprising raw plasma and anticoagulant, wherein the target volume of the plasma product is determined at least in part based on the anticoagulant ratio, the weight, height and hematocrit of the donor before the whole blood is drawn from the donor, and the controller is configured to then control the system to operate the aspiration and return cycles.

21. The system of claim 20, wherein: The controller is configured to determine the target volume of a plasma product based on the total blood volume of the donor and the plasma volume of the donor.

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