Systems and methods for collecting plasma

Abstract

To provide a method for collecting plasma.SOLUTION: The method includes: determining the weight, height, and hematocrit of a donor; and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method includes: then withdrawing blood from the donor through a line connected to a blood component separation device; and introducing an anticoagulant into the withdrawn blood. A blood component separation device 214 separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device into a plasma collection container. The method may include: then calculating the volume of pure plasma collected into the plasma collection container; and continuing processing / collecting until the calculated volume of pure plasma equals the target plasma collection volume.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] Priority This patent application claims priority to U.S. patent application Ser. No. 15 / 793,339, entitled "System and Method for Collecting Plasma," filed October 25, 2017, attorney docket number 130670-08003 (formerly 1611 / C86), with Michael Ragusa as inventor, the disclosure of which is incorporated herein by reference in its entirety.

[0002] and U.S. Patent Application No. 15 / 793,339 is a continuation-in-part of, and claims priority from all priority dates of, Attorney Docket No. 130670-08002 (formerly 1611 / C80), and U.S. Patent Application No. 15 / 608,183, entitled "System and Method for Collecting Plasma," filed May 30, 2017, with Michael Ragusa as an inventor, the disclosures of which are incorporated herein by reference in their entireties.

[0003] The present invention relates to systems and methods for blood apheresis, and more particularly to systems and methods for collecting a plasma product. [Background technology]

[0004] Apheresis is a procedure that allows the separation and collection of individual blood components from whole blood temporarily withdrawn from a subject. Typically, whole blood is withdrawn through a needle inserted into a vein in the subject's arm and into a cell separator, such as a centrifuge bowl. Once the whole blood has been separated into its various components, one or more components (e.g., plasma) can be withdrawn from the centrifuge bowl. The remaining components, along with optional compensation fluids to make up for the volume of the withdrawn components, can be returned to the subject. The withdrawal and return process continues until the desired amount of component is collected, at which point the process stops. The central function of an apheresis system is to return processed but unwanted components to the donor. Separated blood components can include, for example, high-density components such as red blood cells, intermediate-density components such as platelets or white blood cells, and low-density components such as plasma.

[0005] Many jurisdictions have regulations regarding the amount of whole blood and / or blood components that can be withdrawn from a donor. For example, the U.S. Food and Drug Administration ("FDA") imposes both an upper limit on the plasma volume that can be collected (e.g., 800 ml for adults over 175 pounds) and an upper limit on the total collected volume (e.g., 880 ml for adults over 175 pounds). Prior art plasma collection systems are unable to determine the total volume of collected plasma (e.g., because the collected product is a mixture of plasma and anticoagulant) and therefore collect plasma based on the total collected volume, even if the total volume is below the FDA-mandated limit. Furthermore, prior art collection systems do not tailor the amount of collected plasma to an individual (e.g., other than by the weight group into which they are categorized), and therefore, the percentage of a patient's plasma collected varies widely from patient to patient (e.g., some patients collect only 23% of their plasma, while others collect 29% or more). Summary of the Invention

[0006] According to some embodiments of the present invention, a method for collecting plasma includes determining a donor's weight and hematocrit and inserting a venous access device into the donor. Once the venous access device is inserted, the method can draw whole blood from the donor via a draw line connected to the venous access device and a blood component separation device. The method can then introduce an anticoagulant into the drawn whole blood via an anticoagulant line and separate the drawn whole blood into a plasma component and at least a second blood component using the blood component separation device. Once separated, the plasma component can be collected from the blood component separation device into a plasma collection container. During processing, the method can calculate (1) the percentage of anticoagulant in the collected plasma component and (2) the volume of pure plasma collected in the plasma collection container. The volume of pure plasma can be based, at least in part, on the calculated percentage of anticoagulant in the collected plasma component. The method can continue the process (e.g., drawing whole blood, introducing anticoagulant into the whole blood, separating the blood, collecting the plasma, and calculating the percentage of anticoagulant and the volume of pure plasma) until a target volume of pure plasma is collected in the plasma collection container.

[0007] In some embodiments, the method can determine a change in volume within the anticoagulant container, and the calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the change in volume within the anticoagulant container. Additionally or alternatively, the method can determine the volume of anticoagulant introduced into the whole blood based on the rotational speed of the anticoagulant pump. In such embodiments, the calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the rotational speed of the anticoagulant pump. The method can also determine the volume of anticoagulant within the blood component separation device, and the calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the volume of anticoagulant within the blood component separation device.

[0008] In further embodiments, the method can monitor the volume and / or weight of the plasma component collected in the plasma collection container (e.g., using a weight sensor), and the calculated volume of pure plasma collected in the plasma collection device can be based, at least in part, on the monitored volume and / or weight of the collected plasma component. Additionally or alternatively, determining the donor's hematocrit can include monitoring the volume of red blood cell collection in the blood separation device. In such embodiments, the donor's determined hematocrit can be based, at least in part, on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor.

[0009] The target volume of pure plasma can be based, at least in part, on the weight of the donor. The percentage of anticoagulant in the collected plasma component can include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added to the system during the priming step. After collecting at least a portion of the target volume of pure plasma, the method can return the second blood component to the donor through a return line.

[0010] According to a further embodiment, a system for collecting plasma includes a venous access device for drawing whole blood from a subject and returning blood components to the subject, and a blood component separation device for separating the drawn blood into a plasma component and a second blood component. The blood component separation device has an outlet and is configured to deliver the plasma component to a plasma container. The system can also include a blood draw line fluidly connected to the venous access device and an anticoagulant line connected to an anticoagulant source. The blood draw line transports the drawn whole blood to the blood component separation device, and flow through the blood draw line can be controlled by a blood draw pump. The anticoagulant line can introduce anticoagulant into the drawn whole blood.

[0011] Additionally, the system can include a controller that controls the operation of the centrifuge bowl. The controller can also calculate (1) the percentage of anticoagulant in the collected plasma component and (2) the volume of pure plasma collected in the plasma container. The volume of pure plasma can be based, at least in part, on the percentage of anticoagulant in the collected plasma component. When a target volume of pure plasma (e.g., based, at least in part, on the weight of the donor) is collected in the plasma container, the controller can stop the blood draw pump. In some embodiments, the percentage of anticoagulant in the collected plasma component can be based, at least in part, on the volume of anticoagulant added to the drawn whole blood and the subject's hematocrit.

[0012] The system may also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may monitor a change in volume within the anticoagulant container based on the measured weight of the anticoagulant source, and the calculated percentage of anticoagulant in the collected plasma may be based, at least in part, on the change in volume within the anticoagulant source. Additionally or alternatively, the controller may monitor the rotational speed of the anticoagulant pump to determine the volume of anticoagulant introduced into the whole blood. In such an embodiment, the calculated percentage of anticoagulant in the collected plasma may be based, at least in part, on the rotational speed of the anticoagulant pump.

[0013] In some embodiments, the system can include an optical sensor disposed in the blood component separation device. The optical sensor can monitor the contents of the blood component separation device and determine whether a volume of anticoagulant remains in the blood component separation device. The calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the volume of anticoagulant in the blood component separation device.

[0014] In further embodiments, the system can also include a plasma container weight sensor that monitors the volume and / or weight of the plasma component collected in the plasma collection container. The calculated volume of pure plasma collected in the plasma collection container can be based at least in part on the monitored volume and / or weight of the collected plasma component. The system can also include an optical sensor disposed in the blood component separation device. The optical sensor can monitor the volume of red blood cells collected in the blood separation device. The controller can then determine the subject's hematocrit based at least in part on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor. The percentage of anticoagulant in the collected plasma component can include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added to the system during the priming step.

[0015] According to a further embodiment, a method for collecting plasma includes determining a donor's weight, height, and hematocrit and calculating a donor plasma volume based at least in part on the donor's weight, height, and hematocrit. The method then calculates a target plasma collection volume based at least in part on the calculated donor plasma volume and a target percentage of plasma (e.g., between 26.5 and 29.5 percent of the donor's plasma volume), and draws whole blood from the donor via a first line connected to a venous access device and a blood component separation device. Once the whole blood is drawn, the method can introduce an anticoagulant into the drawn whole blood via an anticoagulant line.

[0016] The blood component separation device separates the drawn whole blood into a plasma component and at least a second blood component, and the method can collect the plasma component from the blood component separation device into a plasma collection container. During processing, the method can calculate the volume of pure plasma collected in the plasma collection container. The method continues the steps of drawing, introducing anticoagulant, separating, collecting, and calculating until the volume of pure plasma collected in the plasma collection container equals the target plasma collection volume.

[0017] In some embodiments, after collecting at least a portion of the target plasma collection volume, the method can return the contents of the blood component separation device to the donor through the first line. Additionally or alternatively, the method can calculate an intravascular deficit based, at least in part, on the volume of collected pure plasma and the volume of the contents of the blood component separation device returned to the donor. The method can also return a volume of saline to the donor to obtain the target intravascular deficit. The target intravascular deficit can be between -250 and 500 milliliters (e.g., it can be 0 milliliters or 250 milliliters). The donor's plasma volume can be calculated, at least in part, based on the donor's body mass index, which is calculated based on the donor's weight and height.

[0018] In further embodiments, the method can include calculating the percentage of anticoagulant in the collected plasma component. In such embodiments, the volume of pure plasma can be based, at least in part, on the calculated percentage of anticoagulant in the collected plasma component. The calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on a change in volume in the anticoagulant container, the number of revolutions of the anticoagulant pump, and / or the volume of anticoagulant in the blood component separation device. The method can determine the change in volume in the anticoagulant container, the volume of anticoagulant introduced into the whole blood, and / or the volume of anticoagulant in the blood component separation device. The percentage of anticoagulant in the collected plasma component can include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the priming step.

[0019] In some embodiments, the method can include monitoring the volume and / or weight of the plasma component collected in the plasma collection container. In such embodiments, the calculated volume of pure plasma collected in the plasma collection device can be based, at least in part, on the monitored volume and / or weight of the collected plasma component. To determine the donor's hematocrit, the method can monitor the volume of red blood cells collected in the blood separation device. The donor's hematocrit can be based, at least in part, on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor.

[0020] According to yet a further embodiment, a system for collecting plasma includes a venous access device for drawing whole blood from a subject and returning blood components to the subject, and a blood component separation device for separating the drawn blood into a plasma component and a second blood component. The blood component separation device can have an outlet and can deliver the plasma component to a plasma container. The system can also include a first line and an anticoagulant line. The first line can be fluidly connected to the venous access device and can (1) transport the drawn whole blood to the blood component separation device and (2) return fluid within the blood component separation device to the subject. Flow through the first line can be controlled by a first pump. The anticoagulant line can be connected to an anticoagulant source and can introduce anticoagulant into the drawn whole blood.

[0021] The system can also include a controller that controls operation of the centrifuge bowl and the first pump. The controller can calculate (1) a donor plasma volume, (2) a target plasma collection volume, and (3) a volume of pure plasma collected in the plasma container. The donor plasma volume can be based, at least in part, on the donor's weight and height and the donor's hematocrit. The target plasma collection volume can be based, at least in part, on the calculated donor plasma volume and a target percentage of plasma. The volume of pure plasma collected in the plasma container can be based, at least in part, on the percentage of anticoagulant in the collected plasma component. When the calculated volume of pure plasma collected in the plasma collection container equals the target plasma collection volume, the controller can stop the first pump.

[0022] In a further embodiment, the controller can return fluid remaining in the blood component separation device through the first line after collecting at least a portion of the target plasma collection volume. Additionally or alternatively, the controller can calculate an intravascular deficit based, at least in part, on the volume of pure plasma collected and the volume of the contents of the blood component separation device returned to the donor. The system can also include a saline line fluidly connecting the saline source and the blood component separation device. The controller can return a volume of saline to the donor to achieve a target intravascular deficit (e.g., between −250 and 500 milliliters).

[0023] The controller can calculate the donor's body mass index based at least in part on the donor's weight and height. The donor plasma volume can then be calculated based at least in part on the donor's body mass index. The target percentage of plasma can be between 26.5 and 29.5 percent (e.g., 28.5 percent) of the donor's plasma volume.

[0024] In further embodiments, the controller can calculate the percentage of anticoagulant in the collected plasma component based on, for example, the volume of anticoagulant added to the drawn whole blood and the subject's hematocrit. The system can also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller can then monitor the change in volume in the anticoagulant container based on the measured weight of the anticoagulant source. The calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the change in volume in the anticoagulant source. Additionally or alternatively, the controller can monitor the rotational speed of the anticoagulant pump to determine the volume of anticoagulant introduced into the whole blood. In such embodiments, the calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the rotational speed of the anticoagulant pump.

[0025] The system can also include an optical sensor and / or a plasma container weight sensor. The optical sensor can be disposed in the blood component separation device and can monitor the contents of the blood component separation device to determine whether a volume of anticoagulant remains in the blood component separation device. The calculated percentage of anticoagulant in the collected plasma can be based, at least in part, on the volume of anticoagulant in the blood component separation device. The plasma container weight sensor can monitor the volume and / or weight of the plasma component collected in the plasma container. The calculated volume of pure plasma collected in the plasma collection device can be based, at least in part, on the monitored volume and / or weight of the collected plasma component. The optical sensor can also monitor the volume of red blood cells collected in the blood separation device, and the controller can determine the subject's hematocrit based, at least in part, on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor. The percentage of anticoagulant in the collected plasma component can include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the priming step.

[0026] The foregoing features of the present invention will be more readily understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0027] [Figure 1] FIG. 1 shows a schematic perspective view of a blood processing system according to some embodiments of the present invention.

[0028] [Figure 2] FIG. 2 schematically illustrates a top view of the blood processing system of FIG. 1, according to some embodiments of the present invention.

[0029] [Figure 3]FIG. 3 illustrates a schematic of a disposable set installed in the blood processing system of FIG. 1, according to some embodiments of the present invention.

[0030] [Figure 4] FIG. 4 is a flow chart illustrating a method of collecting plasma according to an embodiment of the present invention.

[0031] [Figure 5] FIG. 5 is a flow chart illustrating an alternative method of collecting plasma according to a further embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0032] Exemplary embodiments of the present invention provide blood processing systems and methods for collecting a target volume of pure plasma. The systems and methods calculate the percentage of anticoagulant collected in a plasma collection container (e.g., in addition to the plasma collected in the container) based on the amount of anticoagulant added to the system and the donor's hematocrit. The systems / methods can then calculate the volume of pure plasma (e.g., anticoagulant-free plasma) being collected in the container. Further embodiments can adjust the volume of plasma collected based on the donor's plasma volume and the target percentage of plasma to collect. Details of exemplary embodiments are described below.

[0033] As shown in FIGS. 1 and 2 , blood processing system 100 includes a cabinet 110 that houses the major components (e.g., non-disposable components) of system 100. Within cabinet 110, system 100 can include a first / blood pump 232 that draws whole blood from a subject and a second / anticoagulant pump 234 that pumps anticoagulant into the whole blood drawn through system 100. Additionally, system 100 can include several valves that can be opened and / or closed to control fluid flow through system 100. For example, system 100 can include a donor valve 120 that can be opened and closed to selectively block and allow fluid flow through donor line 218 (e.g., inlet line; FIG. 3 ), and a plasma valve 130 that selectively blocks and allows fluid flow through outlet / plasma line 222 ( FIG. 3 ). Some embodiments also include a saline valve 135 that selectively blocks and allows saline to flow through saline line 223.

[0034] To facilitate connection and installation of the disposable set and to support corresponding fluid containers, the system 100 may include an anticoagulant pole 150 on which an anticoagulant solution container 210 (FIG. 3) may be hung, and a saline pole 160 on which a saline container 217 (FIG. 3) may be hung (e.g., if the procedure being performed requires the use of saline). Additionally, in some applications, it may be necessary and / or desirable to filter whole blood drawn from the subject for processing. To that end, the system 100 may include a blood filter holder 170 on which a blood filter (disposed in the disposable set) may be placed.

[0035] As discussed in more detail below, an apheresis system 100 according to an embodiment of the present invention uses a blood pump 232 to draw whole blood from a subject through a venous access device 206 ( FIG. 3 ). Once system 100 draws whole blood from the subject, the whole blood enters a blood component separation device 214, such as a Latham-type centrifuge (other types of separation chambers and devices may be used, such as, but not limited to, one-piece blow-molded centrifuge bowls, as described in U.S. Pat. Nos. 4,983,158 and 4,943,273, which are incorporated herein by reference). Blood component separation device 214 separates the whole blood into its constituent components (e.g., red blood cells, white blood cells, plasma, and platelets). Accordingly, to facilitate operation of separation device 214, system 100 may also include a well 180 within which separation device 214 may be placed and within which separation device 214 may rotate (e.g., to generate the centrifugal force necessary to separate the whole blood).

[0036] To allow a user / technician to monitor system operation and control / set various parameters of the procedure, system 100 may include a user interface 190 (e.g., a touchscreen device) that displays operating parameters, any alarm messages, and buttons that the user / technician can press to control various parameters. Further components of blood processing system 100 are discussed in more detail below (e.g., in connection with system operation).

[0037] 3 is a schematic block diagram of a blood processing system 100 and a disposable collection set 200 (having an inlet disposable set 200A and an outlet disposable set 200B) that may be mounted on / in the blood processing system 100 in accordance with the present invention. Collection set 200 includes a venous access device 206 (e.g., a phlebotomy needle) for drawing blood from a donor's arm 208, a container of anticoagulant 210, a centrifuge bowl 214 (e.g., a blood component separation device), a saline container 217, and a final plasma collection bag 216. A blood / inlet line 218 connects venous access device 206 to an inlet port 220 of bowl 214, a plasma / outlet line 222 connects an outlet port 224 of bowl 214 to plasma collection bag 216, and a saline line 223 connects an outlet port 224 of bowl 214 to saline container 217. An anticoagulant line 225 connects anticoagulant container 210 to inlet line 218. 3, the blood processing system 100 includes a controller 226, a motor 228, and a centrifuge chuck 230. The controller 226 is operably coupled to two pumps 232 and 234 and to the motor 228, which in turn drives the chuck 230. The controller 226 is operably coupled to and can communicate with the user interface 190.

[0038] In operation, disposable collection sets 200 (e.g., inlet disposable set 200A and outlet disposable set 200B) can be loaded onto / into blood processing system 100 prior to blood processing. In particular, blood / inlet line 218 is routed through blood / first pump 232, and anticoagulant line 225 from anticoagulant container 210 is routed through anticoagulant / second pump 234. Centrifuge bowl 214 can then be securely attached to chuck 230. Once bowl 214 is secured in place, a technician can install outlet disposable set 200B. For example, a technician can connect bowl connector 300 to outlet 224 of bowl 214, attach plasma container 216 to weight sensor 195, route saline line 223 through valve 135, and route plasma / outlet line 222 through valve 130 and line sensor 185. Once the disposable set 200 is installed and the anticoagulant and saline containers 210 / 217 are connected, the system 100 is ready to begin blood processing.

[0039] FIG. 4 is a flowchart illustrating an exemplary method for collecting plasma, according to various embodiments of the present invention. Prior to connecting a donor to blood processing device 100, it is beneficial (and sometimes necessary) to obtain / determine several pieces of information about the donor: the donor's weight (step 410) and hematocrit (step 415). This information not only helps determine whether the individual is a viable donor and the volume of blood components that can be withdrawn / collected (e.g., in accordance with FDA guidelines), but can also help collect a target volume of plasma using the hematocrit during processing. A technician can obtain / determine the donor's weight by weighing the donor (e.g., with a scale). To obtain / determine the donor's hematocrit, the technician can withdraw a blood sample from the donor and test the blood sample. Additionally or alternatively, the system can determine the hematocrit during blood processing, as discussed in more detail below. For example, the blood processing device 100 may include a hematocrit sensor (not shown) that determines the hematocrit of blood flowing into the blood processing device 100, and / or the system 100 may determine the hematocrit based on the volume of red blood cells collected in the bowl 214.

[0040] Once lines 222 / 223 are in place and the technician has determined the donor's weight and / or hematocrit (if necessary), the user / technician can insert venous access device 206 into donor's arm 208 (step 420). Controller 226 then activates two pumps 232, 234 and motor 228. Operation of two pumps 232, 234 draws whole blood from the donor (step 425), introduces anticoagulant from container 210 into the drawn whole blood (step 430), and delivers the now anticoagulated whole blood to inlet port 220 of bowl 214.

[0041] It should be noted that the anticoagulant line 225 may also include a bacterial filter (not shown) that prevents bacteria within the anticoagulant source 210, the anticoagulant, or the anticoagulant line 225 from entering the system 100 and / or the subject. Additionally, the anticoagulant line 225 may include an air detector 140 that detects the presence of air in the anticoagulant. The presence of air bubbles within any of the lines of the system 100 can be problematic for the operation of the system 100 and may also be harmful to the subject if the bubbles enter the bloodstream. Therefore, the air detector can be connected to an interlock that stops flow in the anticoagulant line 225 (e.g., by stopping the anticoagulant pump 234) if air bubbles are detected, thereby preventing air bubbles from entering the subject.

[0042] Once anticoagulated whole blood is drawn from a subject and contained within the blood component separation device 214, the blood component separation device 214 separates the whole blood into several blood components (step 435). For example, the blood component separation device 214 can separate the whole blood into first, second, third, and possibly fourth blood components. More specifically, the blood component separation device 214 (and the centrifugal force generated by the rotation of the separation device 214) can separate the whole blood into plasma, platelets, red blood cells (“RBCs”), and possibly white blood cells (“WBCs”). The higher density components, i.e., RBCs, are pushed toward the outer walls of the bowl 214, while the lower density plasma is closer to the core. A buffy coat forms between the plasma and the RBCs. The buffy coat is composed of an inner layer of platelets, a transition layer of platelets and WBCs, and an outer layer of WBCs. Plasma is the component closest to the outlet port and is the first fluid component to leave bowl 214 via outlet port 224 as additional anticoagulated whole blood enters bowl 214 through inlet port 220.

[0043] 3, system 100 can also include optical sensor 213 that can be applied to the shoulder of bowl 214. The optical sensor monitors each layer of blood components as it progresses gradually and coaxially from the outer wall toward the core of bowl 214. Optical sensor 213 can be mounted in a location (e.g., in well 180) that can detect buffy coat and / or red blood cells reaching a particular radius, and the steps of drawing whole blood from the subject / donor and introducing the whole blood into bowl 12 can be modified and / or terminated in response to the detection.

[0044] Additionally, in some embodiments, optical sensor 213 can be used to determine the hematocrit of a donor during processing. For example, when bowl 214 is filled with red blood cells and optical sensor 213 detects a layer of red blood cells, system 100 (e.g., a controller) can determine the volume of red blood cells in bowl 214 based on the position of the red blood cell layer and a fixed / known bowl volume. System 100 can then calculate the donor's hematocrit based on the volume of red blood cells in the bowl and the volume of whole blood processed to that point.

[0045] Once the blood component separation device 214 has separated the blood into its various components, one or more components may be removed from the blood component separation device 214. For example, plasma may be removed to a plasma container 216 (e.g., a plasma bottle) via line 222 (step 440). As described above, some embodiments of the system 100 may include a weight sensor 195 (FIG. 1) that measures the amount of collected plasma. The plasma collection process may continue until a target volume of pure plasma (discussed in more detail below) is collected in the plasma collection container 216. Although not shown, if the blood processing system 100 and / or disposable set 200 includes platelet, red blood cell, and / or white blood cell bags, each bag / container may include a similar weight sensor (e.g., a load cell).

[0046] In some embodiments, system 100 can also include line sensor 185 (described above) that can determine the type of fluid (e.g., plasma, platelets, red blood cells, etc.) exiting blood component separation device 214. In particular, line sensor 185 consists of an LED that emits light through the blood components exiting bowl 214 and a photodetector that receives the light after the components have passed through. The amount of light received by the photodetector is correlated with the density of the fluid passing through the line. For example, if plasma is exiting bowl 214, line sensor 185 can detect when the plasma exiting bowl 214 becomes cloudy with platelets (e.g., when the fluid present in bowl 214 is changing from plasma to platelets). System 100 can then use this information to stop the removal of blood components from bowl 214, stop drawing whole blood from the subject, or change the flow, for example, by closing one valve and opening another.

[0047] It is important to note that during processing, the osmolality of red blood cells prevents the anticoagulant introduced into the whole blood from entering / remaining with the red blood cells (e.g., in bowl 214). Rather, the anticoagulant mixes with the plasma components. Thus, the anticoagulant exits bowl 214 with the plasma and is collected with the plasma in collection container 216. In other words, the weight of the product measured by weight sensor 195 is the weight of the plasma as well as the anticoagulant mixed with the plasma; the weight provided by weight sensor 195 is not the weight of pure plasma.

[0048] Furthermore, whole blood contains varying amounts of plasma, as determined by the donor's hematocrit. A typical donor's hematocrit can vary from 38% to 54%, meaning that in 100 ml of whole blood, the amount of plasma can vary from 36 to 62 ml. Furthermore, the amount of anticoagulant added to the drawn whole blood is fixed (e.g., it is independent of the donor's hematocrit), meaning that the percentage of anticoagulant in the collected plasma can vary between 9.7% and 12.7% for donor hematocrits between 38% and 54%, respectively. Thus, not only does the volume measured by weight sensor 195 include the volume of anticoagulant, but that anticoagulant volume can vary from donor to donor based on hematocrit.

[0049] As described above, some embodiments of the present invention continue the blood processing / separation procedure until a target volume of pure plasma (e.g., plasma only—without a volume of anticoagulant mixed with the plasma contained in the target volume) is collected in the plasma collection container 216. To that end, some embodiments of the present invention can calculate the volume of pure plasma in the plasma collection container 216. For example, a technician or the system 100 (e.g., a controller) can calculate the percentage of anticoagulant in the collected plasma (e.g., the plasma contained in the plasma collection container 216) based on the amount of anticoagulant added / metered to the whole blood and the donor's hematocrit (step 455). The technician and / or system can calculate the percentage of anticoagulant according to the following equation, where AC is the amount of anticoagulant added to the system 100: As described above, the osmolality of red blood cells prevents the anticoagulant from mixing with them, so essentially all of the anticoagulant exits the bowl 214 and is collected in the plasma collection container 216 along with the plasma.

number

[0050] The amount of anticoagulant added to system 100 can be determined in several ways. For example, system 100 can base the amount of anticoagulant (e.g., the value of "AC" in the above formula) on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood. In some embodiments, the value of "AC" can be the inverse of the predetermined ratio (e.g., if the ratio of anticoagulant to anticoagulated whole blood is 1:16, then "AC" is 16). Additionally or alternatively, the technician / system 100 can monitor the volume of anticoagulant added to the system. In such an embodiment, the technician / system can monitor the volume of anticoagulant added to system 100 based on the number of revolutions of the anticoagulant pump (e.g., each revolution of the anticoagulant pump introduces a set volume of anticoagulant into system 100) and / or based on the change in weight of anticoagulant container 210 as measured by a weight sensor (discussed in more detail below).

[0051] Once the technician / system 100 calculates the percentage of anticoagulant in the plasma collection container 216, the technician / system 100 can use this information to calculate the volume of pure plasma in the plasma collection container 216 (step 465). For example, the technician / system 100 determines the volume of anticoagulant in the container (based on the percentage of anticoagulant in the container 216) and subtracts this volume from the total volume of fluid in the container 216 as measured by the weight sensor 195. The system 100 continues to monitor the volume of pure plasma collected in the container 216 and can continue processing the whole blood (e.g., can continue performing steps 425, 430, 435, 440, 455, 460, and 465) until a target volume of pure plasma has been collected in the plasma collection container 216 (step 470) (e.g., 800 mL for an adult donor weighing more than 175 pounds, or other limit set by the FDA or similar regulatory agency).

[0052] Once system 100 has collected the target volume of pure plasma in plasma collection container 216, system 100 can return the remaining components (e.g., components remaining in bowl 214) to the subject (step 475). For example, once all the plasma has been removed and bowl 214 is full of RBCs (and other uncollected blood components), controller 226 can stop drawing whole blood from the subject and reverse the direction of blood / first pump 232 to draw RBCs (and other components) from bowl 214 directly back into the subject. Alternatively, if system 100 is so equipped, the system can return the components to the subject via a dedicated return line.

[0053] In addition to the uncollected blood components (e.g., components remaining in bowl 214), system 100 can also return saline to the patient / subject. Saline can be used as a compensation fluid to make up for the volume of blood components (e.g., plasma) that have been removed, collected, and not returned to the patient. To that end, during the return step (e.g., step 475), saline valve 235 can be opened to allow saline from saline container 217 to flow through saline line 223 (via outlet 224) to bowl 214, where it can be returned to the patient / donor with the remaining blood components or thereafter.

[0054] It should be noted that some embodiments may perform several additional and optional steps to help determine the volume of pure plasma in the plasma collection container 216. For example, as described above, some embodiments may monitor the change in weight of the anticoagulant container 210 (e.g., as measured by a weight sensor / load cell in the anticoagulant container 210) (step 445). This measurement provides an indication of the volume of anticoagulant added to the system 100 and can be used to help determine the percentage of anticoagulant in the plasma collection container 216. Additionally or alternatively, some embodiments may similarly monitor the change in weight and / or volume of the plasma and anticoagulant collected in the plasma collection container 216 (e.g., via the weight sensor 195) (step 450). This measurement can be used to calculate the total volume of pure plasma collected in the plasma collection container 216 (e.g., to obtain a total weight from which to subtract the calculated volume of anticoagulant).

[0055] Some embodiments may also (optionally) monitor the volume of anticoagulant remaining in bowl 214 (e.g., anticoagulant that has not mixed with the plasma and / or otherwise remained in the bowl) (step 460). For example, system 100 may utilize an optical sensor in bowl 214 to determine whether anticoagulant remains in bowl 214. If so, method 400 / system 100 may modify the calculation of the volume of pure plasma collected in the plasma collection container (e.g., by increasing or decreasing the calculated volume) based on the volume of anticoagulant remaining in bowl 214.

[0056] The various embodiments of the present invention described above offer many advantages over prior art plasma collection systems. In particular, as noted above, prior art plasmapheresis devices terminate plasma collection based on the total volume of anticoagulated plasma (e.g., pure plasma and added anticoagulant). While this is the simplest method because it only requires weighing the product collection container, the amount of true product—pure plasma—depends on the donor's hematocrit. In other words, prior art systems end up collecting more plasma from low-hematocrit donors than from high-hematocrit donors due to variations in the percentage of anticoagulant in the product. Various embodiments of the present invention address the problems of prior art systems by collecting a standard volume (e.g., a target volume) of pure plasma from each donor. As noted above, embodiments of the present invention accomplish this by determining the percentage of anticoagulant in the product using knowledge of the donor's hematocrit and the amount of anticoagulant collected in the plasma collection container 216 (e.g., by counting pump rotations and / or using a scale / weight sensor, etc.). Furthermore, by stopping the plasma collection process based on the volume of pure plasma collected, embodiments of the present invention are able to collect larger volumes of plasma compared to prior art systems that stop based on the plasma / anticoagulant mixture.

[0057] FIG. 5 illustrates another method of collecting plasma using the system shown in FIGS. 1-3 (or a similar system) based on a total volume of plasma to be collected from an individual donor (e.g., based on height, weight, hematocrit, blood volume, and / or plasma volume). In a manner similar to that described above for the method shown in FIG. 4, before connecting the donor to blood processing device 100, the system / method can obtain / determine several pieces of information about the donor, namely, the donor's weight and height (step 505) and hematocrit (step 510). For example, a technician can obtain / determine the donor's weight by weighing the donor (e.g., on a scale) and the donor's height by measuring the donor. To obtain / determine the donor's hematocrit (e.g., in a manner similar to that described above), a technician can test a blood sample, or the system can determine the hematocrit during blood processing using a hematocrit sensor and / or based on the volume of red blood cells collected in bowl 214.

[0058] Using the donor's height and weight and hematocrit, the system 100 / method 500 can calculate the donor's plasma volume (e.g., the volume of plasma in the donor's blood) (step 515). For example, the system 100 / method 500 can calculate the donor's / subject's body mass index ("BMI") using the donor's height and weight (e.g., BMI = weight / height), and then use the calculated BMI to calculate the donor's / subject's total blood volume (see, e.g., Lemmens et al., Estimating Blood Volume in Obese and Morbidly Obese Patients, Obesity Surgery, 2006:16, 773-776, the subject matter of which is incorporated herein by reference). The total blood volume can be calculated using the following equation:

[0059]

number

[0060] In the above equation, InBV is the indexed blood volume (e.g., the donor's total blood volume), BMIp is the patient's BMI (e.g., kg / m), 22 is the BMI value at ideal body weight (IBW) (e.g., kg / m), and 70 is the donor's total blood volume (mL / kg) at ideal body weight (BMI=22 kg / m). Once system 100 has calculated the total blood volume in the donor / subject, system 100 (e.g., a controller) can determine / calculate the volume of plasma in the donor's blood (step 515), for example, based on the donor's hematocrit.

[0061] As noted above, the embodiment shown in FIG. 5 is based on the volume of plasma to be collected for each individual donor. Therefore, once the system 100 / method 500 determines the donor's plasma volume, the system 100 / method 500 can then determine a target volume of plasma to collect (step 520). For example, the system 100 / method 500 can multiply the total plasma volume in the patient by the target percentage of plasma to collect to arrive at the target plasma volume to collect (e.g., total plasma volume is 2700 ml, target percentage to collect is 28.5%, and target plasma volume to collect is 769.5 ml). The target percentage of plasma to collect may be application and / or donor dependent and may be entered directly into the system 100 (e.g., using the user interface 190) or may be preset from the factory. In some embodiments, the target percentage may be between 26.5 and 30%, preferably 28.5%. However, in other embodiments, the target percentage may be less than 26.5% or greater than 30%.

[0062] Once lines 222 / 223 are in place and system 100 / method 500 has calculated the target plasma volume, the user / technician can insert venous access device 206 into donor's arm 208 (step 525). Next, controller 226 activates two pumps 232, 234 and motor 228 in a manner similar to that described above for the method shown in FIG. 4. Operation of the two pumps 232, 234 causes whole blood to be drawn from the donor (step 530), anticoagulant from container 210 is introduced into the drawn whole blood (step 535), and the now anticoagulated whole blood is delivered to inlet port 220 of bowl 214.

[0063] When anticoagulated whole blood is drawn from a subject and introduced into blood component separation device 214, blood component separation device 214 separates the whole blood into its respective blood components (e.g., plasma, platelets, RBCs, and possibly WBCs) (step 540). As described above, the higher density components, i.e., RBCs, are forced toward the outer wall of bowl 214, and plasma is the component closest to the outlet port and, therefore, is the first fluid component to exit bowl 214 via outlet port 224 as additional anticoagulated whole blood enters bowl 214 through inlet port 220. During separation and processing, optical sensor 213 monitors each layer of blood components as it gradually and coaxially advances from the outer wall toward the core of bowl 214, and the steps of drawing whole blood from the subject / donor and introducing the whole blood into bowl 214 can be modified and / or terminated in response to the detection. Additionally, as described above, optical sensor 213 can be used to determine the donor's hematocrit during processing (eg, if it is unknown and / or determined before processing begins).

[0064] Once blood component separation device 214 has separated the blood into its various components, plasma may be removed via line 222 to plasma container 216 (e.g., a plasma bottle) (step 545). As noted above, some embodiments of system 100 may include weight sensor 195 (FIG. 1) to measure the amount of collected plasma. The plasma collection process may continue until a target plasma collection volume (discussed in more detail below) has been collected in plasma collection container 216. If equipped with line sensor 185, system 100 may use information from sensor 185 to stop the removal of blood components from bowl 214, stop the withdrawal of whole blood from the subject, or redirect flow, for example, by closing one valve and opening another.

[0065] As described above, some embodiments of the present invention continue the blood processing / separation procedure until the target plasma collection volume is collected. To ensure that this volume does not include the volume of anticoagulant collected in the container 216, the target plasma collection volume must include only the volume of pure plasma (e.g., plasma only—no volume of anticoagulant mixed with the plasma contained in the target volume). To that end, in a manner similar to that described above, some embodiments of the present invention can calculate the volume of pure plasma in the plasma collection container 216. To determine the volume of pure plasma, a technician or the system 100 (e.g., a controller) can calculate the percentage of anticoagulant in the collected plasma (e.g., the plasma contained in the plasma collection container 216) based on the amount of anticoagulant added / metered to the whole blood and the donor's hematocrit (see equation above) (step 560). The amount of anticoagulant added to the system 100 can be determined in any of the ways described above (e.g., based on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood by monitoring the volume of anticoagulant added to the system).

[0066] Once the technician / system 100 calculates the percentage of anticoagulant in the plasma collection container 216, the technician / system 100 can use this information to calculate the volume of pure plasma in the plasma collection container 216 (step 570). For example, as described above, the technician / system 100 can determine the volume of anticoagulant in the container (based on the percentage of anticoagulant in the container 216), as measured by weight sensor 195, and subtract this volume from the total volume of fluid in the container 216. The system 100 continues to monitor the volume of pure plasma collected in the container 216 and can continue processing the whole blood (e.g., can continue performing steps 530, 535, 540, 545, 560, 570, and possibly steps 550, 555, and 565) until the volume of pure plasma collected in the plasma collection container 216 reaches a target plasma volume (step 575) (e.g., calculated based on the donor's individual plasma volume and the target percentage of plasma to collect).

[0067] Once system 100 has collected the target plasma volume in plasma collection container 216, system 100 can return the remaining components (e.g., components remaining in bowl 214) to the subject by stopping the withdrawal of whole blood from the subject and reversing the direction of blood / first pump 232 to draw RBCs (and other components) from bowl 214 and return them to the subject (e.g., directly via blood / inlet line 218 or, if equipped, via a dedicated return line) (step 580).

[0068] It is important to note that because system 100 / method 500 collects and does not return a portion of the blood components (e.g., plasma), the volume of fluid returned to the donor / subject is less than the volume removed. This then creates an intravascular deficit (e.g., the volume of whole blood removed from the donor minus the volume of plasma collected / not returned) equal to the amount of plasma collected. If the intravascular deficit is too large, the donor risks fainting when getting up to leave the facility once the procedure is complete. As noted above, to reduce the intravascular deficit (and the risk of donor injury), some embodiments of the present invention return saline to the patient / subject (step 585). Saline can be used as a compensation fluid to make up for the volume of blood components (e.g., plasma) removed. To that end, during the return step (e.g., step 580), the controller 226 (or technician) can open the saline valve 217 to allow saline from the saline container 217 to flow through the saline line 223 (via the outlet 224) to the bowl 214, where it can be returned to the patient / donor with the remaining blood components or thereafter.

[0069] As described above, the volume of plasma collected from a donor varies from donor to donor (e.g., based on the donor's height, weight, hematocrit, and blood volume). Therefore, the volume of saline returned to the donor to mitigate the intravascular deficit may similarly depend on the donor. To that end, when returning the contents of the separation device and saline to the donor (steps 580 and 585), system 100 / method 500 can calculate the intravascular deficit (step 590) based on the total volume of whole blood removed from the donor and the volume of returned blood components and saline (or based on the volume of collected plasma and the volume of returned blood components and saline). System 100 / method 500 can continue to return saline until the donor's intravascular deficit reaches a target intravascular deficit (step 595).

[0070] The target intravascular deficit can be any intravascular deficit that reduces the risk of donor syncope and can be the same for each donor. For example, the target intravascular deficit can be set at 0 mL or 250 mL for each donor. Alternatively, like the target plasma volume to collect, the target intravascular deficit can vary from donor to donor. In other words, the target intravascular deficit can be set at 0 mL for some donors and 250 mL for other donors. Note that 0 and 250 mL are provided as examples only; other embodiments can have a target intravascular deficit between 0 and 250 mL or greater than 250 mL. Furthermore, in some instances, it may be beneficial to return more fluid to the donor than was removed / collected. In such cases, the target intravascular deficit can be set below zero (e.g., -1 to -250 mL), thereby allowing the donor to have more fluid / volume after the procedure than before.

[0071] Similar to method 400 shown in FIG. 4, method 500 may similarly perform several additional and optional steps to help determine the volume of pure plasma in the plasma collection container 216. For example, some embodiments may monitor the change in weight of the anticoagulant container 210 (e.g., as measured by a weight sensor / load cell in the anticoagulant container 210) (step 550). This measurement provides an indication of the volume of anticoagulant added to the system 100 and can be used to help determine the percentage of anticoagulant in the plasma collection container 216. Additionally or alternatively, some embodiments may similarly monitor (e.g., via weight sensor 195) the change in weight and / or volume of the plasma and anticoagulant collected in the plasma collection container 216 (step 555). This measurement may be used to calculate the total volume of pure plasma collected in the plasma collection container 216 (e.g., to obtain the total weight minus the calculated volume of anticoagulant). Additionally, some embodiments may also use an optical sensor in bowl 214 to monitor the amount of anticoagulant remaining in bowl 214 (e.g., anticoagulant that has not mixed with the plasma and / or otherwise remained in the bowl) (step 565) to determine whether anticoagulant remains in bowl 214 and alter (e.g., calculate a larger amount or a smaller amount) the calculation of the amount of pure plasma collected in the plasma collection container based on the volume of anticoagulant remaining in bowl 214.

[0072] As noted above, prior art systems following the current FDA nomogram for plasma collection collect the volume of plasma product (e.g., anticoagulant-plasma mixture) based solely on the donor's weight—the same volume is collected from all donors at the same weight. However, the total blood and plasma volumes of two donors can vary significantly. For example, comparing two donors within the same weight group according to the FDA nomogram—one obese and one non-obese—the obese donor will have a substantially lower blood volume than the non-obese donor. Furthermore, with respect to total plasma volume, donors with higher hematocrits will have a lower plasma volume. In other words, because total blood and plasma volumes vary from donor to donor (even among donors of the same weight), the percentage of donor plasma ultimately collected can vary significantly from donor to donor. By tailoring plasma collection to the donor (e.g., based on the donor's height, weight, BMI, hematocrit, total blood volume, and / or total plasma volume) and collecting a predetermined percentage of plasma from each donor, embodiments of the present invention may collect greater volumes of plasma (e.g., pure plasma) from some donors, but less plasma from more vulnerable donors (e.g., thinner donors with high hematocrit, donors with lower plasma volumes, etc.), compared to systems that do not base collection volumes on individual donors.

[0073] Similarly, current systems do not tailor saline return volumes to patients (e.g., each donor at a given level receives the same amount of saline, but if the target plasma product volume is 800 mL, for example, the donor will receive 500 mL of saline). However, prior art systems collect based on the volume of plasma product (including both plasma and anticoagulant), and the actual volume of pure plasma collected (and therefore the volume removed from the donor) varies based on the donor's hematocrit, resulting in a different intravascular deficit for each donor. In other words, the volume of saline returned to a donor may be sufficient for some but insufficient for others. By tailoring saline return to individual donors, embodiments of the present invention can ensure that each donor has the same intravascular deficit (if any) upon completion of the procedure. This, in turn, allows embodiments of the present invention to achieve isovolemic hemodynamics for each donor and significantly reduce any adverse reactions the donor may experience (e.g., falls, fainting, lightheadedness, vasovagal reactions, etc.).

[0074] Exemplary embodiments of methods for operating a system for collecting plasma from donated whole blood of the present invention, and in which the system comprises combinations of various components of the present invention, are set forth below. 1. The method, further comprising, after collecting at least a portion of the target plasma collection volume, activating the controller to return the contents of the blood component separation device to the first line. 2. The method of claim 1, further comprising operating the controller to calculate the intravascular deficit based at least in part on the volume of collected pure plasma and the volume of the returned contents of the blood component separation device. 3. The method further comprising operating the controller to calculate the donor's body mass index based at least in part on the donor's weight and height, wherein the donor's total plasma volume is calculated based at least in part on the donor's body mass index. 4. A method wherein the target percentage of plasma is between 26.5 and 29.5 percent of the donor's total plasma volume. 5. The method, further comprising operating the controller to calculate a volume of anticoagulant in the collected plasma component based at least in part on the hematocrit of the donor, wherein the volume of pure plasma is based at least in part on the calculated volume of anticoagulant in the collected plasma component. 6. The method of claim 5, further comprising activating the controller to determine a change in volume within the anticoagulant container, wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the change in volume within the anticoagulant container. 7. The method of claim 5, further comprising operating the controller to determine a volume of anticoagulant to be introduced into the whole blood based on the rotational speed of the anticoagulant pump, wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the rotational speed of the anticoagulant pump. 8. The method of claim 5, further comprising operating the controller to determine a volume of anticoagulant in the blood component separation device, wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the volume of anticoagulant in the blood component separation device. 9. The method of claim 5 above, wherein the volume of anticoagulant in the collected plasma component includes at least a portion of the volume of anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the priming step. 10. The method, further comprising operating the controller to monitor a volume of the plasma component collected in the plasma collection container, wherein the calculated volume of pure plasma collected in the plasma collection container is based at least in part on the monitored volume of the collected plasma component. 11. The method, further comprising operating the controller to monitor a weight of the plasma component collected in the plasma collection container, wherein the calculated volume of pure plasma collected in the plasma collection container is based at least in part on the monitored weight of the collected plasma component. 12. A method for operating a system for collecting plasma from provided whole blood of the present invention, wherein step (b) of acquiring information about the donor's hematocrit includes operating a controller to monitor the volume of red blood cells collected in the blood component separation device, and the acquired donor's hematocrit is based at least in part on the monitored volume of red blood cells collected in the blood component separation device and the volume of whole blood drawn from the donor.

[0075] 13. A venous access device for withdrawing whole blood from a donor and returning blood components to the donor; a blood component separation device for separating the drawn blood into a plasma component and a second blood component, wherein the blood component separation device has an outlet and is configured to deliver the plasma component to a plasma container; a first line fluidly connected to the venous access device and configured to transport drawn whole blood to the blood component separation device and return fluid within the blood component separation device to the donor, wherein flow through the first line is controlled by a first pump; an anticoagulant line connected to an anticoagulant source, wherein the anticoagulant line is configured to introduce anticoagulant into the drawn whole blood; and a controller configured to control operation of the blood component separation device and the first pump, wherein the controller is configured to calculate (1) a donor's total plasma volume based at least in part on the donor's weight and height and the donor's hematocrit, (2) a target plasma collection volume based at least in part on the calculated donor's total plasma volume and a target percentage of plasma, and (3) a volume of pure plasma collected in the plasma container based at least in part on a volume of anticoagulant in the collected plasma component, and wherein the controller is configured to stop the first pump when the calculated volume of pure plasma collected in the plasma container equals the target plasma collection volume; 1. A system for collecting plasma comprising: 14. In the system of claim 13, the controller is further configured to return fluid remaining in the blood component separation device through the first line after collecting at least a portion of the target plasma collection volume. 15. The system of claim 14, wherein the controller is further configured to calculate an intravascular deficit based at least in part on the volume of pure plasma collected and the volume of the contents of the blood component separation device returned to the donor. 16. The system of claim 15, further comprising a saline line configured to fluidly connect to the saline source and the blood component separation device, and the controller configured to return a volume of saline to the donor to obtain a target intravascular deficit. 17. In the system of claim 16, the target intravascular deficit is between -250 and 500 milliliters. 18. In the system of claim 13, the controller is further configured to calculate the donor's body mass index based at least in part on the donor's weight and height, and wherein the donor's total plasma volume is calculated based at least in part on the donor's body mass index. 19. In the system of claim 13 above, the target percentage of plasma is between 26.5 and 29.5 percent of the donor's total plasma volume. 20. The system of claim 13, wherein the controller is further configured to calculate a volume of anticoagulant in the collected plasma component based at least in part on the donor's hematocrit. 21. The system of claim 20, wherein the volume of anticoagulant in the collected plasma component is based at least in part on the volume of anticoagulant added to the drawn whole blood and the donor's hematocrit. 22. The system of claim 20, further comprising an anticoagulant source weight sensor configured to measure the weight of the anticoagulant source, wherein the controller is further configured to monitor a change in volume within the anticoagulant source based on the measured weight of the anticoagulant source, and wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the change in volume within the anticoagulant source. 23. The system of claim 20, wherein the controller is configured to monitor the rotational speed of the anticoagulant pump to determine the volume of anticoagulant introduced into the whole blood, and wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the rotational speed of the anticoagulant pump. 24. The system of claim 20, further comprising an optical sensor disposed in the blood component separation device and configured to monitor the contents of the blood component separation device to determine whether a volume of anticoagulant remains in the blood component separation device, wherein the calculated volume of anticoagulant in the collected plasma component is based at least in part on the volume of anticoagulant in the blood component separation device. 25. The system of claim 13, further comprising a plasma container weight sensor configured to monitor a volume of plasma components collected in the plasma container, wherein the calculated volume of pure plasma collected in the plasma container is based at least in part on the monitored volume of the collected plasma components. 26. The system of claim 13, further comprising a plasma container weight sensor configured to monitor the weight of a plasma component collected in the plasma container, wherein the calculated volume of pure plasma collected in the plasma container is based at least in part on the monitored weight of the collected plasma component. 27. The system of claim 13, further comprising an optical sensor disposed in the blood component separation device and configured to monitor a volume of red blood cells collected in the blood component separation device, and the controller configured to determine the donor's hematocrit based at least in part on the monitored volume of red blood cells collected in the blood component separation device and the volume of whole blood drawn from the donor.

[0076] It is also important to note that while the various embodiments described above relate to blood processing systems that collect plasma, the features described herein may be applied to any type of blood processing system. For example, the features described herein may be implemented in blood processing systems that collect and / or process red blood cells, platelets, and / or white blood cells.

[0077] The above-described embodiments of the present invention are intended to be merely illustrative and numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in the appended claims.

Claims

1. 1. A method of operating a system for collecting plasma, the system including a controller, the controller comprising: (a) determining the weight and height of the donor; (b) determining the donor's hematocrit; (c) calculating the donor's total plasma volume based at least in part on the donor's weight, height, and the donor's hematocrit; (d) calculating a target plasma volume to collect based at least in part on the calculated donor's total plasma volume and the target percentage of plasma; (e) operating the system to introduce anticoagulant via the anticoagulant line into the whole blood being drawn at that time; (f) operating the system to separate the drawn whole blood into a plasma component and at least a second blood component; (g) collecting the plasma component from the blood component separation device into a plasma collection container; and (h) continuing steps (e) through (g) until a target plasma volume for collection in the plasma collection container is reached.

2. The method of claim 1, wherein the controller is further configured to perform, after step (b) and before step (d), a step of calculating the volume of anticoagulant to be collected in the plasma collection container together with the plasma component based at least in part on the donor's hematocrit.

3. 3. The method of claim 2, wherein the target plasma volume to collect is a target volume of pure plasma to collect in a plasma collection container, and the target volume of pure plasma to collect is based at least in part on a volume of anticoagulant to collect with the plasma component in the plasma collection container.

4. The method of claim 1, wherein step (c) further comprises calculating the donor's body mass index based at least in part on the donor's weight and height, and calculating the donor's total plasma volume based at least in part on the donor's body mass index.

5. 10. The method of claim 1, wherein the target plasma volume to be collected is calculated prior to drawing whole blood.

6. 10. The method of claim 1, wherein the target percentage of plasma is between 26.5 and 29.5 percent of the donor's plasma volume.

7. 1. A system for collecting plasma, comprising: a venous access device for drawing whole blood from a donor and returning blood components to the donor; a blood component separation device for separating the drawn blood into a plasma component and a second blood component, the blood component separation device having an outlet and configured to deliver the plasma component to a plasma collection container; a first line fluidly connected to the venous access device and configured to transport drawn whole blood to the blood component separation device and return fluid within the blood component separation device to the donor, wherein flow through the first line is controlled by a first pump; an anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the drawn whole blood; and a controller configured to control operation of the blood component separation device and the first pump, the controller comprising: (1) calculating the donor's total plasma volume based at least in part on the donor's weight, height, and the donor's hematocrit; (2) calculating a target plasma volume to collect based at least in part on the calculated donor total plasma volume and the target percentage of plasma; and (3) configured to calculate a volume of the plasma component collected in the plasma collection container, wherein the target plasma volume to be collected is calculated prior to drawing the whole blood; The controller is configured to stop the first pump when the calculated volume of the plasma component collected in the plasma collection container equals the target plasma volume to collect.

8. 8. The system of claim 7, wherein the controller is configured to calculate a volume of anticoagulant to collect with the plasma component in the plasma collection container, wherein the volume of anticoagulant to collect with the plasma component is based at least in part on the hematocrit of the donor.

9. 9. The system of claim 8, wherein the target plasma volume to collect is a target volume of pure plasma to collect.

10. 9. The system of claim 8, wherein the target plasma volume to collect is a target volume of pure plasma to collect in the plasma collection container, the target volume of pure plasma to collect is based at least in part on a volume of anticoagulant to collect with the plasma component in the plasma collection container, and the controller is configured to stop the first pump when the volume of pure plasma collected in the plasma collection container equals the target plasma collection volume.

11. 10. The system of claim 7, wherein the controller is further configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and to calculate a total plasma volume of the donor based at least in part on the body mass index of the donor.

12. 8. The system of claim 7, wherein the target percentage of plasma is between 26.5 and 29.5 percent of the donor's plasma volume.

13. A method for programming a blood processing device in a system for collecting plasma, the system comprising: (a) obtaining the weight and height of the donor; (b) obtaining the donor's hematocrit; (c) calculating the donor's total plasma volume based at least in part on the donor's height, weight, and the donor's hematocrit; (d) calculating a target plasma volume to collect based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma; (e) programming a blood processing end point into a controller of the blood processing device, wherein the blood processing end point is based at least in part on a target plasma volume to be collected.

14. The method described in claim 13, wherein the system is further configured to perform, after step (b) and before step (d), a step of calculating the volume of anticoagulant to be collected with the plasma component in the plasma collection container based at least in part on the donor's hematocrit.

15. 15. The method of claim 14, wherein the target plasma volume to collect is a target volume of pure plasma to collect, the target volume of pure plasma being based at least in part on a volume of anticoagulant to collect with the plasma component.

16. The method of claim 13, wherein step (c) further comprises calculating the donor's body mass index based at least in part on the donor's weight and height, and calculating the donor's total plasma volume based at least in part on the donor's body mass index.

17. 14. The method of claim 13, wherein the end point of blood processing is when a target plasma volume to be collected in a plasma collection container of the blood processing device has been collected.

18. The method of claim 13, wherein the system includes a controller.

19. 1. A system for collecting plasma, comprising: A blood processing device and a controller are included; The blood processing device a venous access device for withdrawing whole blood from a donor and returning blood components to the donor; a blood component separation device for separating the drawn blood into a plasma component and a second blood component, wherein the blood component separation device has an outlet and is configured to deliver the plasma component to a plasma collection container; a blood draw line fluidly connected to the venous access device and configured to transport drawn whole blood to the blood component separation device, wherein flow through the blood draw line is controlled by a blood draw pump; and an anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the drawn whole blood; The controller (1) calculating the donor's total plasma volume based at least in part on the donor's weight, height, and the donor's hematocrit; and (2) A system that calculates a target plasma volume to collect based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma, and the system for collecting plasma is configured to collect the calculated target plasma volume by the controller.

20. 20. The system of claim 19, wherein the blood processing device stops the blood withdrawal pump when a target plasma volume to be collected in the plasma collection container has been collected.

21. 20. The system of claim 19, wherein the controller is further configured to program a blood processing end point into the blood processing device for ending processing of the collected plasma based on a target plasma volume to be collected.

22. 22. The system of claim 21, wherein the end of blood processing is when the target plasma volume to be collected has been collected in the plasma collection container.

23. 20. The system of claim 19, wherein the target plasma volume to collect is a target volume of pure plasma to collect in the plasma collection container, and the target volume of pure plasma to collect is based at least in part on a volume of anticoagulant to collect with the plasma component in the plasma collection container.

24. 20. The system of claim 19, wherein the controller is further configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and to calculate a total plasma volume of the donor based at least in part on the body mass index.

25. 10. The method of claim 1, wherein the target percentage of plasma is greater than 29.5 percent of the donor plasma volume.

26. 10. The method of claim 1, wherein the target percentage of plasma is greater than 30 percent of the donor plasma volume.

27. 8. The system of claim 7, wherein the target percentage of plasma is greater than 29.5 percent of the donor plasma volume.

28. The system of claim 7 , wherein the target percentage of plasma is greater than 30 percent of the donor plasma volume.

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