System and method for collecting plasma

Abstract

To provide a method for collecting plasma.SOLUTION: A method for collecting plasma comprises determining the weight, the height and the hematocrit of a donor, and calculating donor plasma volume and target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method comprises then withdrawing blood from the donor through a line connected to a blood component separation device, and introducing an anticoagulant into the withdrawn blood. The blood component separation device 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 comprise then calculating volume of pure plasma collected within 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 "SYSTEMS AND METHODS FOR COLLECTING PLASMA," filed Oct. 25, 2017, with Attorney Docket No. 130670-08003 (formerly 1611 / C86), 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, U.S. Patent Application No. 15 / 608,183, entitled "SYSTEMS AND METHODS FOR COLLECTING PLASMA," filed May 30, 2017, having Attorney Docket No. 130670-08002 (formerly 1611 / C80), and 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is a procedure in which individual blood components can be separated and collected from whole blood temporarily withdrawn from a subject. Typically, whole blood is withdrawn through a needle inserted into a vein in the subject's arm and into a cell separator, such as a centrifuge bowl. Once the whole blood has been separated into its various components, one or more components (e.g., plasma) can be withdrawn from the centrifuge bowl.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 can be returned to the subject along with optional compensation fluid to make up for the volume of the withdrawn components. The withdrawal and return process continues until the desired amount of component has been collected, at which point the process stops. The central function of an apheresis system is for the processed but unwanted components to be returned to the donor. The 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 removed from a donor. For example, the U.S. Food and Drug Administration ("FDA") has established both an upper limit on the plasma volume that can be collected (e.g., 800 ml for adults over 175 pounds), as well as 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 plasma collected (e.g., because the collected product is a mixture of plasma and anticoagulant), and therefore collect based on the total collected volume, even if the total volume of plasma collected is below the limits set forth by the FDA. Furthermore, prior art collection systems do not tailor the amount of plasma collected to an individual (e.g., outside of 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 have only 23% of their plasma collected, while others have 29% or more of their plasma collected). 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) a percentage of anticoagulant in the collected plasma component, and (2) a 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 to 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 in 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 in the anticoagulant container. Additionally or alternatively, the method can determine a 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 a volume of anticoagulant in 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 in 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 a volume of red blood cell collection in the blood separation device. In such embodiments, the determined hematocrit of the donor 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 the 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 a source of anticoagulant. 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 an 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 hematocrit of the subject.

[0012] The system may also include an anticoagulant source weight sensor that measures a weight of the anticoagulant source. The controller may monitor a change in volume in 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 in the anticoagulant source. Additionally or alternatively, the controller may monitor a 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 a further embodiment, 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 have 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 a hematocrit of the subject 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 determines a donor's weight, height, and hematocrit, and calculates 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 the venous access device and the blood component separation device. Once the whole blood is drawn, the method can introduce an anticoagulant via an anticoagulant line into the drawn whole blood.

[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 a 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. Further, additionally or alternatively, the method 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 method can also return a volume of saline to the donor to obtain a 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 a 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 the 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 have 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 fluids in 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 may also include a controller that controls operation of the centrifuge bowl and the first pump. The controller may 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 may be based, at least in part, on the donor's weight and height and the donor's hematocrit. The target plasma collection volume may 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 may be based, at least in part, on a 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 may stop the first pump.

[0022] In a further embodiment, the controller can return the fluid remaining in the blood component separation device via 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 obtain a target intravascular deficit (e.g., between -250 and 500 milliliters).

[0023] The controller can calculate a body mass index of the donor based at least in part on the weight and height of the donor. A donor plasma volume can then be calculated based at least in part on the body mass index of the donor. 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 hematocrit of the subject. 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 number of revolutions 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 number of revolutions of the anticoagulant pump.

[0025] The system may also include an optical sensor and / or a plasma container weight sensor. The optical sensor may be disposed in the blood component separation device and may 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 may be based, at least in part, on the volume of anticoagulant in the blood component separation device. The plasma container weight sensor may 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 may be based, at least in part, on the monitored volume and / or weight of the collected plasma component. The optical sensor may also monitor the volume of red blood cells collected in the blood separation device, and the controller may determine the hematocrit of the subject 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 description of the drawings]

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

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

[0029] [Diagram 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] [Diagram 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 PREFERRED EMBODIMENTS

[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., plasma without anticoagulant) that is 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 Figures 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 the flow of fluids 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; Figure 3), and a plasma valve 130 that selectively blocks and allows fluid flow through outlet / plasma line 222 (Figure 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 can include an anticoagulant pole 150 on which an anticoagulant solution container 210 (FIG. 3) can be hung, and a saline pole 160 on which a saline container 217 (FIG. 3) can be hung (e.g., if the procedure to be performed requires the use of saline). Furthermore, 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 can include a blood filter holder 170 on which a blood filter (located in the disposable set) can 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). As the system 100 draws whole blood from a subject, the whole blood enters a blood component separation device 214, such as a Latham-type centrifuge (other types of separation chambers and devices can 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). The blood component separation device 214 separates the whole blood into its constituent components (e.g., red blood cells, white blood cells, plasma, and platelets). Thus, to facilitate operation of the separation device 214, the system 100 can also include a well 180, within which the separation device 214 can be placed and within which the separation device 214 rotates (e.g., to generate the centrifugal force necessary to separate the whole blood).

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

[0037] 3 is a schematic block diagram of blood processing system 100 and a disposable collection set 200 (having inlet disposable set 200A and outlet disposable set 200B) that may be mounted on / in 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) may be mounted on / in 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 may then be securely mounted to chuck 230. Once bowl 214 is secured in place, a technician may install outlet disposable set 200B. For example, a technician may 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 flow chart illustrating an exemplary method of collecting plasma, according to various embodiments of the present invention. Prior to connecting a donor to the blood processing device 100, it is beneficial (and in some cases necessary) to obtain / determine some information about the donor, namely the donor's weight (step 410) and hematocrit (step 415). This information can help determine whether an individual is a viable donor and the volume of blood components that can be withdrawn / collected (e.g., in accordance with FDA guidelines), as well as help collect a target volume of plasma using the hematocrit during processing. A technician can obtain / determine the donor's weight by measuring the donor's weight (e.g., with a scale). To obtain / determine the donor's hematocrit, the technician can draw 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 the 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 the venous access device 206 into the donor's arm 208 (step 420). The controller 226 then activates the two pumps 232, 234 and the motor 228. Operation of the two pumps 232, 234 draws whole blood from the donor (step 425), introduces anticoagulant from the container 210 into the drawn whole blood (step 430), and the anticoagulated whole blood is now delivered to the inlet port 220 of the bowl 214.

[0041] It should be noted that the anticoagulant line 225 may also include a bacterial filter (not shown) that prevents bacteria in 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 air bubbles enter the bloodstream. Thus, the air detector can be connected to an interlock that stops the 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 the 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 a first, second, third, and possibly a fourth blood component. 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 forced toward the outer wall of the bowl 214, while the lower density plasma is closer to the core. A buffy coat is formed 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 exit port and is the first fluid component to leave bowl 214 via exit port 224 as additional anticoagulated whole blood enters bowl 214 through inlet port 220.

[0043] 3, system 100 can also include an optical sensor 213 that can be applied to a shoulder of bowl 214. The optical sensor monitors each layer of blood components as they progress gradually and coaxially from the outer wall of bowl 214 toward the core. 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 fills 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 location 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 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 noted above, some embodiments of the system 100 may include a weight sensor 195 (FIG. 1) that measures the amount of plasma collected. 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 a 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 passing through the components. 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 the red blood cells prevents the anticoagulant introduced to the whole blood from entering / remaining in 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 in collection container 216 with the plasma. 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, and the weight provided by weight sensor 195 is not the weight of pure plasma.

[0048] Furthermore, whole blood contains a varying amount of plasma, as determined by the donor's hematocrit. A typical donor's hematocrit can vary from 38% to 54%, i.e., 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), i.e., 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 volume of anticoagulant can vary from donor to donor based on hematocrit.

[0049] As discussed above, some embodiments of the present invention continue the blood processing / separation procedure until a target volume of pure plasma (e.g., plasma only - no 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, the technician or the system 100 (e.g., controller) can calculate the percentage of anticoagulant in the collected plasma (e.g., 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 discussed above, the osmolality of red blood cells prevents the anticoagulant from mixing with it, 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 the system 100 can be determined in a number of ways. For example, the 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 was 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 the 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 the system 100) and / or based on the change in weight of the anticoagulant container 210 as measured by a weight sensor (discussed in more detail below).

[0051] Once the technician / system 100 has calculated 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 can continue to monitor the volume of pure plasma collected in the container 216 and 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 forth by the FDA or similar regulatory agency).

[0052] Once system 100 has collected a target volume of pure plasma in plasma collection container 216, system 100 may 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 blood components not collected), controller 226 may stop drawing whole blood from the subject and reverse the direction of blood / first pump 232 to draw the RBCs (and other components) from bowl 214 directly back to the subject. Alternatively, if system 100 is so equipped, the system may return the components to the subject via a dedicated return line.

[0053] In addition to blood components that were not collected (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 were removed and collected and not returned to the patient. To that end, during a 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 with the remaining blood components or thereafter to the patient / donor.

[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 of 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 remains 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 provide 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). This is the simplest method since it only requires weighing the product collection container, but the amount of true product - pure plasma - is dependent on the donor's hematocrit. In other words, prior art systems will collect more plasma from low hematocrit donors than from high hematocrit donors due to the variation 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 using knowledge of the donor's hematocrit and the amount of anticoagulant collected in the plasma collection container 216 to determine the percentage of anticoagulant in the product (e.g., by counting pump revolutions and / or using a scale / weight sensor, etc.). Additionally, 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 for an individual donor (e.g., based on height, weight, hematocrit, blood volume, and / or plasma volume). In a similar manner as described above for the method shown in FIG. 4, prior to connecting the donor to the blood processing device 100, the system / method can obtain / determine several 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 similar manner as 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 the 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 / height2) and then calculate the total blood volume in the donor / subject using the calculated BMI (see, e.g., Lemmens et al., Estimating Blood Volume in Obese and Morbidly ObesePatients, 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 / m2), 22 is the BMI value at ideal body weight (IBW) (e.g., kg / m2), and 70 is the donor's total blood volume (mL / kg) at ideal body weight (BMI=22 kg / m2). Once the system 100 has calculated the total blood volume in the donor / subject, the 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. Thus, once the system 100 / method 500 has determined 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 can be application and / or donor dependent, and can be entered directly into the system 100 (e.g., using the user interface 190) or can be pre-set from the factory. In some embodiments, the target percentage can be between 26.5 and 30%, and preferably 28.5%. However, in other embodiments, the target percentage may be less than 26.5% or more than 30%.

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

[0063] When anticoagulated whole blood is drawn from the 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 exit port and is therefore the first fluid component to exit bowl 214 via exit 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 advances gradually and coaxially from the outer wall of bowl 214 toward the core, 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 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 the blood component separation device 214 has separated the blood into its various components, plasma may be removed (step 545) via line 222 to a plasma container 216 (e.g., a plasma bottle). As noted above, some embodiments of the system 100 may include a weight sensor 195 (FIG. 1) that measures the amount of plasma collected. The plasma collection process may continue until a target plasma collection volume (discussed in more detail below) has been collected in the plasma collection container 216. If equipped with a line sensor 185, the system 100 may use information from the sensor 185 to stop the removal of blood components from the bowl 214, stop the withdrawal of whole blood from the subject, or redirect the 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 a 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, the technician or the system 100 (e.g., controller) can calculate the percentage of anticoagulant in the collected plasma (e.g., 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 manners 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 has calculated 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, optionally, 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 draw 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 the system 100 / method 500 does not collect and return some 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 is at risk of fainting when getting up to leave the facility once the procedure is complete. As noted above, to reduce the intravascular deficit (and risk of donor injury), some embodiments of the 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 a 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 along with the remaining blood components or thereafter.

[0069] As discussed above, the volume of plasma collected from a donor will vary from donor to donor (e.g., because it is based on the donor's height, weight, hematocrit, and blood volume). Thus, the volume of saline returned to the donor to alleviate the intravascular deficit may be donor dependent as well. To that end, when returning the contents of the separation device and saline to the donor (steps 580 and 585), the system 100 / method 500 may calculate an intravascular deficit (step 590) based on the total volume of whole blood removed from the donor and the volume of blood components and saline returned (or based on the volume of plasma collected and the volume of blood components and saline returned). The system 100 / method 500 may 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 fainting and can be the same for each donor. For example, the target intravascular deficit can be set to 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 to 0 mL for some donors and 250 mL for other donors. Note that 0 and 250 mL are provided only as examples, and other embodiments can have a target intravascular deficit between 0 and 250 mL or greater than 250 mL. Additionally, 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 may be set below zero (e.g., -1 to -250 mL), such that the donor has more fluid / volume after the procedure than before the procedure.

[0071] Similar to the method 400 shown in FIG. 4, the 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 of 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 the weight sensor 195) the change in weight and / or volume of the plasma and anticoagulant collected in the plasma collection container 216 (step 555). Using this measurement, the total volume of pure plasma collected in the plasma collection container 216 may be calculated (e.g., the total weight minus the calculated volume of anticoagulant may be obtained). Additionally, some embodiments may also use an optical sensor in the bowl 214 to monitor the amount of anticoagulant remaining in the bowl 214 (e.g., anticoagulant that has not mixed with the plasma and / or otherwise remains in the bowl) (step 565) to determine whether anticoagulant remains in the bowl 214 and alter the calculation of the amount of pure plasma collected in the plasma collection container (e.g., calculate an amount larger or calculate an amount smaller) based on the volume of anticoagulant remaining in the bowl 214.

[0072] As noted above, prior art systems following the current FDA nomogram for plasma collection collect a volume of plasma product (e.g., anticoagulant mixed with plasma) 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, when comparing two donors in the same weight group according to the FDA nomogram - one obese and one non-obese - the obese donor will effectively have a lower blood volume than the non-obese donor. Furthermore, in terms of total plasma volume, a donor with a high hematocrit will have a lower plasma volume. In other words, because the total blood and plasma volumes vary from donor to donor (even between donors of the same weight), the percentage of donor plasma that is 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 hematocrits, donors with lower plasma volumes, etc.), compared to systems that are not based on individual donor collection volumes.

[0073] Similarly, current systems do not tailor the saline return volume to the patient (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 volume of pure plasma actually collected (and therefore 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 the donor may be sufficient for some but insufficient for others. By tailoring the saline return to the individual donor, 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 hematomyelia for each donor, significantly reducing any adverse reactions that 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 an intravascular deficit based at least in part on the volume of pure plasma collected and the volume of the contents of the returned blood component separation device. 3. The method, further comprising operating the controller to calculate a body mass index of the donor 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 donor's hematocrit, 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 operating the controller to determine a change in volume in 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 in 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 obtaining information about the donor's hematocrit in step (b) includes operating a controller to monitor a volume of red blood cells collected in the blood component separation device, and the obtained 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, where 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, where flow through the first line is controlled by a first pump; an anticoagulant line connected to an anticoagulant source, where 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 a 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; 16. A system for collecting plasma comprising: 14. The system of claim 13, wherein 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 a saline source and to 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. The system of claim 13, wherein the controller is further configured to calculate a body mass index of the donor 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. A system according to claim 13, wherein 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 a weight of the anticoagulant source, and 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 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 the 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 volume of the collected plasma component. 26. The system of claim 13, further comprising a plasma container weight sensor configured to monitor a weight of a plasma component collected in the plasma container, wherein a 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 although 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 embodiments of the invention described above 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 invention as defined in the appended claims.

Claims

1. 1. A system for collecting plasma, comprising: a venipuncture needle configured to draw whole blood from a donor; a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to deliver the plasma product to a plasma product collection container; a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor into the blood separator, the donor line having flow controlled by a first pump; an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to couple anticoagulant to the whole blood from the donor, flow through the anticoagulant line controlled by a second pump; a user interface configured to receive input from an operator; a controller coupled to the user interface and programmed to control operation of the system, the controller being programmed to determine a target volume of plasma product and / or unprocessed plasma based at least in part on the donor's total blood volume and / or the donor's plasma volume, the determined target volume of plasma product and / or unprocessed plasma being an optimized safe amount to be collected from the donor, and the controller being programmed to control the system to perform at least one withdrawal and return step to withdraw whole blood from the donor, separate the whole blood into the plasma product and the second blood component, and return the second blood component to the donor; Including, the system.

2. The system of claim 1 , wherein the controller is configured to receive at least the donor's hematocrit, and / or weight and height.

3. 10. The system of claim 1, wherein the controller is programmed to determine a target volume of the plasma product and / or unprocessed plasma before initiation of the withdrawal and return process.

4. 2. The system of claim 1, wherein the controller is programmed to initiate a final return of the second blood component when (1) a measured volume of plasma product in the plasma product collection container reaches a target volume of the plasma product, and / or (2) a volume of unprocessed plasma in the plasma collection container reaches a target volume of the unprocessed plasma.

5. 10. The system of claim 1, wherein the controller is programmed to determine the donor's total blood volume based on a plurality of parameters selected from the group consisting of the donor's weight, height, sex, age, and morphology.

6. 2. The system of claim 1, wherein the controller is programmed to perform the at least one withdrawal and return step at least three times, and the controller is programmed to determine a volume of whole blood withdrawn in a final withdrawal step that is different from a volume withdrawn in a previous withdrawal step.

7. 2. The system of claim 1, wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until a collected volume of the plasma product reaches a target volume of the plasma product and / or untreated plasma.

8. 10. The system of claim 1, wherein a control system is programmed to calculate a target volume of the plasma product and / or unprocessed plasma, and wherein the controller is programmed to determine the target volume of the plasma product and / or unprocessed plasma by receiving the target volume of the plasma product and / or unprocessed plasma from the control system.

9. an anticoagulant source weight sensor configured to measure a weight of the anticoagulant source; The system of claim 1 further comprising:

10. The system of claim 9 , wherein the controller is further configured to monitor a change in volume within the anticoagulant source based on a measured weight of the anticoagulant source.

11. 11. The system of claim 10, wherein the controller is further configured to calculate a volume of anticoagulant collected in the plasma product collection container based at least in part on the change in volume in the anticoagulant source.

12. The system of claim 1 , wherein the controller is further configured to monitor a rotational speed of the second pump.

13. 13. The system of claim 12, wherein the controller is further configured to calculate a volume of anticoagulant collected in the plasma product collection container based at least in part on the number of revolutions of the second pump.

14. 13. The system of claim 12, wherein the controller is further configured to calculate a total volume of anticoagulant added to the system during a collection process based at least in part on the number of revolutions of the second pump.

15. a plasma product collection container weight sensor configured to measure a weight of a plasma component collected in the plasma product collection container; The system of claim 1 further comprising:

16. 1. A system for collecting plasma, comprising: a venipuncture needle configured to draw whole blood from a donor; a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to deliver the plasma product to a plasma product collection container; a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor into the separator, the donor line having flow controlled by a first pump; an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to couple anticoagulant to the whole blood from the donor, flow through the anticoagulant line controlled by a second pump; a user interface configured to receive input from an operator; a controller coupled to the user interface and programmed to control operation of the system, the controller being programmed to determine a target volume of plasma product and / or unprocessed plasma based at least in part on donor parameters and based on the donor's total blood volume and / or the donor's plasma volume, the determined target volume of plasma product and / or unprocessed plasma being an optimized safe amount to be collected from the donor, and the controller being further configured to control the system to perform drawing and returning steps to draw whole blood from the donor, separate the whole blood into the plasma product and the second blood component, and return the second blood component to the donor; Including, the system.

17. 17. The system of claim 16, wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until a collected volume of the plasma product reaches a target volume of the plasma product and / or unprocessed plasma.

18. 17. The system of claim 16, further comprising a control system, the control system in electronic communication with the controller, the control system programmed to calculate a target volume of the plasma product and / or untreated plasma, and the controller programmed to determine the target volume of the plasma product and / or untreated plasma by receiving the target volume of the plasma product and / or untreated plasma from the control system.

19. 17. The system of claim 16, wherein the controller determines the target volume of the plasma product and / or untreated plasma by calculating a target volume of the plasma product and / or untreated plasma, and the controller is proximate to and coupled to the blood separator.

20. 17. The system of claim 16, wherein the controller is configured to electronically receive the donor parameters, the donor parameters including donor weight and / or hematocrit, and the controller is programmed to determine a target volume of the plasma product and / or unprocessed plasma based at least in part on the donor weight and / or hematocrit.

21. 17. The system of claim 16, wherein the controller is programmed to determine the donor's total blood volume based on the donor's weight and height.

22. 17. The system of claim 16, wherein the controller is programmed to determine the donor's total blood volume prior to drawing whole blood from the donor during a blood donation.

23. 17. The system of claim 16, wherein the target volume of the plasma product and / or unprocessed plasma is determined prior to drawing the whole blood from the donor based at least in part on an anticoagulant ratio, the donor's weight, or the donor's hematocrit.

24. an anticoagulant source weight sensor configured to measure a weight of the anticoagulant source; The system of claim 16 further comprising:

25. 25. The system of claim 24, wherein the controller is further configured to monitor a change in volume within the anticoagulant source based on a measured weight of the anticoagulant source.

26. 26. The system of claim 25, wherein the controller is further configured to calculate a volume of anticoagulant collected in the plasma product collection container based at least in part on the change in volume in the anticoagulant source.

27. The system of claim 16 , wherein the controller is further configured to monitor a rotational speed of the second pump.

28. 28. The system of claim 27, wherein the controller is further configured to calculate a volume of anticoagulant collected in the plasma product collection container based at least in part on the number of revolutions of the second pump.

29. 28. The system of claim 27, wherein the controller is further configured to calculate a total volume of anticoagulant added to the system during a collection process based at least in part on the number of revolutions of the second pump.

30. a plasma product collection container weight sensor configured to measure a weight of a plasma component collected in the plasma product collection container; The system of claim 16 further comprising:

31. 1. A system for collecting plasma, comprising: a venous access device for drawing whole blood from a donor and returning blood components to said donor; a blood component separation device for separating the drawn whole blood into a plasma component and at least 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; a controller configured to control operation of the blood component separation device and the first pump, the controller configured to calculate a target plasma volume to collect based at least in part on the donor's total blood volume and the donor's hematocrit, the donor's total blood volume being determined at least in part on the donor's weight and height, and the target plasma volume to collect being calculated for the donor; A system including:

32. 32. The system of claim 31, wherein the controller is further configured to stop collecting plasma once the target amount of plasma to be collected has been collected in the plasma collection container.

33. 32. The system of claim 31, wherein the controller is configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and wherein the target plasma volume to collect is calculated based at least in part on the body mass index of the donor.

34. 32. The system of claim 31, wherein the controller is further configured to calculate the donor's total blood volume.

35. 32. The system of claim 31, wherein the calculated target plasma volume to collect is an optimized safe volume to be collected from the donor.

36. The controller After collecting at least a portion of the target plasma volume to be collected, the contents of the blood separation device are returned to the donor through the first line.

32. The system of claim 31, further configured to:

37. 32. The system of claim 31, wherein the target plasma volume to collect is a target volume of pure plasma to collect or a target volume of anticoagulated plasma to collect.

38. 1. A system for collecting plasma, comprising: a venous access device for drawing whole blood from a donor and returning blood components to said donor; a blood component separation device for separating the drawn whole blood into a plasma component and at least 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; a controller configured to control operation of the blood component separation device and the first pump, the controller being configured to (1) receive individual characteristics of the donor, the individual characteristics including the donor's weight, height, and hematocrit, and (2) calculate a target plasma volume to collect based at least in part on the donor's total blood volume and the donor's hematocrit, wherein the donor's total blood volume is determined based at least in part on the donor's weight and height, and the target plasma volume to collect is calculated to suit the donor's individual characteristics; A system including:

39. 39. The system of claim 38, wherein the controller is further configured to calculate the donor's total blood volume.

40. 39. The system of claim 38, wherein the controller is further configured to stop collecting the plasma component once the target amount of plasma to be collected has been collected in the plasma collection container.

41. 39. The system of claim 38, wherein the controller is configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and wherein the target plasma volume to collect is calculated based at least in part on the body mass index of the donor.

42. The controller After collecting at least a portion of the target plasma volume to be collected, the contents of the blood separation device are returned to the donor through the first line.

39. The system of claim 38, further configured to:

43. 39. The system of claim 38, wherein the target volume of plasma to collect is a target volume of pure plasma to collect or a target volume of anticoagulated plasma to collect.

44. 39. The system of claim 38, wherein the target plasma volume to be collected is an optimized safe volume to be collected from the donor.

45. a plasma collection container weight sensor configured to monitor the volume or weight of a plasma component collected in the plasma collection container; 39. The system of claim 38, further comprising:

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