CN111465421A

CN111465421A - Systems and methods for collecting plasma

Info

Publication number: CN111465421A
Application number: CN201880079926.0A
Authority: CN
Inventors: M·拉古萨
Original assignee: American Blood Technologies
Current assignee: American Blood Technologies
Priority date: 2017-10-25
Filing date: 2018-10-25
Publication date: 2020-07-28
Anticipated expiration: 2038-10-25
Also published as: JP7390287B2; RU2020116822A; EP3700606A4; KR20240017096A; CA3079851A1; KR102629919B1; AU2018355417A1; KR20200078553A; CN111465421B; WO2019084278A1; EP3700606A1; JP2021500950A; RU2020116822A3; JP2023154074A

Abstract

A method of collecting plasma includes determining a donor's weight, height, and hematocrit, 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 the target percentage of plasma. The method then draws blood from the donor through a line connected to the blood component separation device and introduces anticoagulant into the drawn 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 and collected into a plasma collection container. The method may then calculate the volume of pure plasma collected in the plasma collection container and continue processing/collection until the calculated volume of pure plasma equals the target plasma collection volume.

Description

Systems and methods for collecting plasma

Priority

This patent application claims priority from U.S. patent application No. 15/793,339 entitled "System and Method for collecting Plasma", attorney docket No. 130670 and 08003 (formerly 1611/C86), filed on 25/10/2017, the entire disclosure of which is incorporated herein by reference.

U.S. application No. 15/793,339 is further a continuation of and claiming all priority from U.S. patent application No. 15/608,183 (attorney docket No. 130670-08002 (formerly 1611/C80) and Michael Ragusa, inventor) entitled "System and method for Collecting Plasma" filed on 30.5.2017, the entire disclosure of which is incorporated herein by reference.

Technical Field

The present invention relates to systems and methods for blood apheresis, and more particularly, to systems and methods for collecting plasma products.

Background

Apheresis is a procedure in which individual blood components can be separated and collected from whole blood that is temporarily drawn from a subject. Typically, whole blood is drawn through a needle inserted into a vein in the arm of the subject and into a cell separator (e.g., a centrifuge bowl). Once the whole blood is separated into its various components, one or more components (e.g., plasma) may be removed from the centrifuge drum. The remaining components may be returned to the subject with an optional compensation fluid (to compensate for the volume of component withdrawn). The process of drawing and returning continues until a certain amount of the desired component is collected, and then the process is stopped. The main feature of the apheresis system is the return of processed, but not required, components to the donor. The separated blood components may include, for example, high density components such as red blood cells, medium density components such as platelets or white blood cells, and low density components such as plasma.

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") sets an upper limit on the collectable plasma volume (e.g., 800 milliliters for adults weighing more than 175 pounds) and an upper limit on the total collection volume (e.g., 880 milliliters for adults weighing more than 175 pounds). The 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 based on the total collection volume even though the total volume of collected plasma is below the FDA specified limit. In addition, prior art collection systems do not adjust the amount of plasma collected for an individual (e.g., to be different from the body recombination to which they belong), and therefore, the percentage of patient plasma collected varies widely between patients (e.g., only 23% of plasma is collected for some patients, while 29% (or more) of plasma is collected for others).

Summary of The Invention

According to some embodiments of the invention, a method for collecting plasma includes determining a weight and hematocrit of a donor and inserting a venous access device into the donor. Once the venous-access device is inserted, the method may draw whole blood from the donor through the venous-access device and a draw line connected to the blood component separation device. The method may then introduce anticoagulant into the drawn whole blood through the 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 may calculate (1) the percentage of anticoagulant in the collected plasma components, and (2) the volume of pure plasma collected in the plasma collection container. The volume of the pure plasma may be based at least in part on a calculated percentage of anticoagulant in the collected plasma components. The method may continue the process (e.g., drawing whole blood, introducing anticoagulant into whole blood, separating blood, collecting 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.

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

In further embodiments, the method may monitor the volume and/or weight of the plasma constituent 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 may be based at least in part on the monitored volume and/or weight of the collected plasma constituent. Additionally or alternatively, determining the donor's hematocrit may include monitoring the 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.

The target volume of the pure plasma may be based at least in part on the body weight of the donor. The percentage of anticoagulant in the collected plasma constituent may 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 may return the second blood component to the donor via a return line.

According to further embodiments, a system for collecting plasma comprises: 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 a plasma component to a plasma container. The system may also include a blood withdrawal line fluidly connected to the venous-access device and an anticoagulant line connected to an anticoagulant source. The blood withdrawal line delivers the withdrawn whole blood to the blood component separation device and the flow through the blood withdrawal line may be controlled by a blood withdrawal pump. The anticoagulant line may introduce anticoagulant into the drawn whole blood.

Additionally, the system may include a controller that controls operation of the centrifugal drum. The controller may also calculate (1) the percentage of anticoagulant in the collected plasma components, and (2) the volume of pure plasma collected in the plasma container. The volume of the pure plasma may be based at least in part on the percentage of anticoagulant in the collected plasma components. The controller may stop the blood draw pump 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. In some embodiments, the percentage of anticoagulant in the collected plasma constituent may be based at least in part on the volume of anticoagulant added to the drawn whole blood and the hematocrit of the subject.

The system may also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may monitor a volume change 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 volume change within the anticoagulant source. Additionally or alternatively, the controller may 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 may be based at least in part on the number of revolutions of the anticoagulant pump.

In some embodiments, the system may include an optical sensor located on the blood component separation device. The optical sensor may 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 may be based at least in part on the volume of anticoagulant in the blood component separation device.

In further embodiments, the system may further comprise a plasma container weight sensor that monitors the volume and/or weight of the plasma constituent collected in the plasma collection container. The calculated volume of pure plasma collected in the plasma collection container may be based at least in part on the monitored volume and/or weight of the collected plasma components. The system may also have an optical sensor located on the blood component separation device. The optical sensor may monitor the volume of red blood cells collected in the blood separation device. The controller may then 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 may 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 filling step.

According to further embodiments, the method for collecting plasma determines a weight, a height, and a hematocrit of the donor, and calculates a donor plasma volume based at least in part on the weight, the height, and the hematocrit of the donor. 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., 26.5% to 29.5% of the donor plasma volume), and draws whole blood from the donor via the venous-access device and the first line connected to the blood component separation device. As whole blood is drawn, the method may introduce anticoagulant into the drawn whole blood through the anticoagulant line.

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 blood components from the plasma component separation device into a plasma collection container. During processing, the method may 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.

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

In a further embodiment, the method may include calculating the percentage of anticoagulant in the collected plasma constituent. In such embodiments, the volume of pure plasma may be based at least in part on the calculated percentage of anticoagulant in the collected plasma constituents. The calculated percentage of anticoagulant in the collected plasma may be based at least in part on a change in volume in the anticoagulant container, a number of revolutions of the anticoagulant pump, and/or a volume of anticoagulant in the blood component separation device. The method may determine a change in volume in the anticoagulant container, a volume of anticoagulant introduced into the whole blood, and/or a volume of anticoagulant in the blood component separation device. The percentage of anticoagulant in the collected plasma component may 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 filling step.

In some embodiments, the method may include monitoring the volume or weight of the plasma constituent collected in the plasma collection container. In such embodiments, 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 components. 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 may 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.

According to further embodiments, 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 may have an outlet and may deliver the plasma component to the plasma container. The system may also have a first line and an anticoagulant line. The first line may be fluidly connected to the venous-access device and may (1) convey the drawn whole blood to the blood component separation device and (2) return fluid in the blood component separation device to the subject. The flow through the first line may be controlled by a first pump. The anticoagulant line may be connected to an anticoagulant source, and may introduce anticoagulant into the drawn whole blood.

The system may also include a controller that controls operation of the centrifugal drum and the first pump. The controller may calculate (1) the donor plasma volume, (2) the target plasma collection volume, and (3) the volume of pure plasma collected in the plasma container. The donor plasma volume may be based at least in part on the weight and height of the donor and the hematocrit of the donor. The target plasma collection volume may be based at least in part on the calculated target percentage of the donor plasma volume and plasma. The volume of pure plasma collected in the plasma container may be based at least in part on the percentage of anticoagulant in the collected plasma components. The controller may stop the first pump when the calculated volume of pure plasma collected in the plasma collection container equals the target plasma collection volume.

In further embodiments, the controller may return fluid retained 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 may calculate the intravascular insufficiency based at least in part on a volume of the collected pure plasma and a volume of contents of the blood component separation device returned to the donor. The system may also include a saline line fluidly connected to the saline source and the blood component separation device. The controller may return a volume of saline to the donor to obtain the target intravascular insufficiency (e.g., -250 to 500 milliliters).

The controller may calculate a body mass index of the donor based at least in part on the weight and the height of the donor. Further, the donor plasma volume can be calculated based at least in part on the body mass index of the donor. The target percentage of plasma may be 26.5% to 29.5% (e.g., 28.5%) of the volume of donor plasma.

In further embodiments, the controller may calculate the percentage of anticoagulant in the collected plasma component, for example, based on the volume of anticoagulant added to the drawn whole blood and the hematocrit of the subject. The system may also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may then monitor the volume change in the anticoagulant container based on the measured weight of the anticoagulant source. 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 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 may be based at least in part on the number of revolutions of the anticoagulant pump.

The system may also include an optical sensor and/or a plasma container weight sensor. The optical sensor may be located on 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 then 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 constituent collected in the plasma container. The volume of pure plasma collected in the plasma collection device may then be calculated based at least in part on the monitored volume and/or weight of the plasma constituent. The optical sensor may also monitor a 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 may include at least a portion of the anticoagulant introduced into the blood and at least a portion of the volume of anticoagulant added during the filling step.

Brief description of the drawings

The foregoing features of the invention will be more readily understood by reference to the following detailed description and by reference to the accompanying drawings, in which:

fig. 1 schematically illustrates a perspective view of a blood processing system according to some embodiments of the present invention.

Fig. 2 schematically illustrates a top view of the blood processing system of fig. 1, according to some embodiments of the present invention;

fig. 3 schematically illustrates a disposable kit installed within the blood processing system of fig. 1 according to some embodiments of the present invention.

Fig. 4 is a flow chart depicting a method of collecting plasma according to an embodiment of the invention.

Fig. 5 is a flow chart depicting an alternative method of collecting plasma according to other embodiments of the present invention.

Detailed description of the specific embodiments

The illustrative 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 the 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 hematocrit of the donor. The system/method may then calculate the volume of pure plasma (e.g., plasma without anticoagulant) that has been collected in the container. Further embodiments may adjust the volume of plasma collected based on the donor's plasma volume and the target percentage of plasma to be collected. Details of illustrative embodiments are discussed below.

As shown in fig. 1 and 2, the blood processing system 100 includes a housing 110, the housing 110 housing the major components (e.g., non-disposable components) of the system 100. Within housing 110, system 100 may include a first/blood pump 232 and a second/anticoagulant pump 234, first/blood pump 232 drawing whole blood from the subject, second/anticoagulant pump 234 pumping anticoagulant through system 100 and into the drawn whole blood. Additionally, the system 100 may include a plurality of valves that may be opened and/or closed to control the flow of fluid through the system 100. For example, the system 100 can include a donor valve 120 that can be opened and closed to selectively prevent and allow fluid flow through the donor line 218 (e.g., inlet line; fig. 3), and a plasma valve 130 that selectively prevents and allows fluid flow through the outlet/plasma line 222 (fig. 3). Some embodiments may also include a brine valve 135 that selectively prevents and allows brine to flow through the brine line 223.

To facilitate connection and installation of the disposable set and support the respective fluid containers, system 100 may include an anticoagulant rod 150 and a saline rod 160, an anticoagulant solution container 210 (fig. 3) may be suspended from anticoagulant rod 150, and a saline solution container 217 (fig. 3) may be suspended from saline rod 160 (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 a subject for processing. To this end, the system 100 may include a blood filter holder 170 into which a blood filter (located on a disposable set) may be placed.

As discussed in more detail below, apheresis system 100 according to embodiments of the present invention uses a blood pump 232 to draw whole blood from a subject through venous access device 206 (fig. 3.) as system 100 draws whole blood from a subject, whole blood enters a blood component separation device 214, such as an L atham-type centrifuge (other types of separation chambers and devices may be used, such as, but not limited to, integrally blow-molded centrifuge drums, as described in U.S. patent nos. 4,983,158 and 4,943,273 (which are incorporated herein by reference)).

To allow the user/technician to monitor system operation and control/set various parameters of the program, the system 100 may include a user interface 190 (e.g., a touch screen device) that presents operating parameters, any alarm messages, and buttons that the user/technician may press to control various parameters. Other components of the blood processing system 100 are discussed in more detail below (e.g., with respect to system operation).

Fig. 3 is a schematic block diagram of a blood processing system 100 and a disposable collection kit 200 (with an inlet disposable kit 200A and an outlet disposable kit 200B) that may be loaded onto/into the blood processing system 100 according to the present invention. The collection kit 200 includes a venous-access device 206 (e.g., a venous blood collection needle) for drawing blood from an arm 208 of a donor, an anticoagulant container 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 couples venous access device 206 to an inlet end 220 of drum 214, a plasma/outlet line 222 couples an outlet end 224 of drum 214 to plasma collection bag 216, and a saline line 223 connects outlet end 224 of drum 214 to a saline container 217. Anticoagulant line 225 connects anticoagulant container 210 to inlet line 218. In addition to the components described above and as shown in fig. 3, blood processing system 100 also includes a controller 226, a motor 228, and a centrifuge chuck 230. The controller 226 is operatively coupled to two

pumps

232 and 234 and a motor 228, which in turn drives a chuck 230. The controller 226 may be operatively coupled to and in communication with the user interface 190.

In operation, disposable collection set 200 (e.g., inlet disposable set 200A and outlet disposable set 200B) may 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. The centrifuge drum 214 may then be securely loaded into the chuck 230. Once the drum 214 is secured in place, the technician may install the disposable exit set 200B. For example, the technician may connect the drum connector 300 to the outlet 224 of the drum 214, install the plasma container 216 into the weight sensor 195, pass the saline line 223 through the valve 135, and pass the plasma/outlet line 222 through the valve 130 and line sensor 185. Once disposable set 200 is installed and anticoagulant and saline container 210/217 is connected, system 100 is ready to begin blood processing.

Fig. 4 is a flow chart depicting an exemplary method of collecting plasma according to various embodiments of the present invention. Before connecting the donor to the blood processing apparatus 100, it is beneficial (and may be necessary in some cases) to obtain/determine certain information about the donor, namely the weight of the donor (step 410) and the hematocrit (step 415). This information is useful not only to determine whether an individual is a viable donor, but also to determine the volume of blood components that can be drawn/collected (e.g., according to FDA guidelines), and hematocrit can be used during processing to help collect a target volume of plasma. The technician may obtain/determine the weight of the donor by weighing the donor (e.g., on a scale). To obtain/determine the donor's hematocrit, a technician may draw a blood sample from the donor and test the blood sample. Additionally or alternatively, as discussed in more detail below, the system may determine hematocrit during blood processing. For example, blood processing device 100 may include a hematocrit sensor (not shown) that determines the hematocrit of blood flowing into blood processing device 100 and/or system 100 may determine the hematocrit based on the volume of red blood cells collected within drum 214.

Once line 222/223 is in place and the technician has determined the donor's weight and/or hematocrit (if needed), the user/technician may insert venous access device 206 into the donor's arm 208 (step 420). Next, the controller 226 activates the two

pumps

232, 234 and the motor 228. Operation of the two

pumps

232, 234 causes whole blood to be drawn from the donor (step 425), anticoagulant from the container 210 is introduced into the drawn whole blood (step 430), and the now anticoagulated whole blood will be delivered to the inlet end 220 of the drum 214.

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

When anticoagulated whole blood is withdrawn from the subject and contained in 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 may separate whole blood into first, second, third, and possibly fourth blood components. More specifically, the blood component separation device 214 (and the centrifugal force created by the rotation of the separation device 214) is capable of separating whole blood into plasma, platelets, red blood cells ("RBCs"), and possibly white blood cells ("WBCs"). The higher density components (i.e., RBCs) are forced to the outer wall of the drum 214, while the lower density plasma is closer to the center. A buffy coat is formed between the plasma and RBC. The buffy coat consists of an inner layer of platelets, a transitional layer of platelets and WBCs, and an outer layer of WBCs. Plasma is the component closest to the outlet end and is the first fluid component that exits the drum 214 through the outlet end 224 as additional anticoagulated whole blood enters the drum 214 through the inlet end 220.

As shown in fig. 3, the system 100 may further include an optical sensor 213, which optical sensor 213 may be applied to a shoulder of the rotating drum 214. The optical sensor monitors each layer of blood components as they are gradually and coaxially advanced from the outer wall of drum 214 toward the center. Optical sensor 213 may be mounted in a position (e.g., within compartment 180) where it is capable of detecting buffy coat and/or red blood cells reaching a particular radius, and in response to detection, the steps of drawing whole blood from the subject/donor and introducing the whole blood into drum 12 may be altered and/or terminated.

Additionally, in some embodiments, the optical sensor 213 may be used to determine the hematocrit of the donor during processing. For example, when the drum 214 is filled with red blood cells and the optical sensor 213 detects a layer of red blood cells, the system 100 (e.g., controller) can determine the volume of red blood cells within the drum 214 based on the location of the layer of red blood cells and the fixed/known drum volume. The system 100 may then calculate the donor hematocrit based on the volume of red blood cells within the bowl and the volume of whole blood that has been processed at that time.

Once blood component separation device 214 separates the blood into various components, one or more components may be removed from blood component separation device 214. For example, plasma may be withdrawn through line 222 to plasma container 216 (e.g., a plasma bottle) (step 440). As described 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 is collected in the plasma collection container 216 (discussed in more detail below). Although not shown, if the blood processing system 100 and/or disposable kit 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 sensor).

In some embodiments, system 100 may also include a line sensor 185 (as described above) that may determine the type of fluid exiting blood component separation device 214 (e.g., plasma, platelets, red blood cells, etc.). in particular, line sensor 185 consists of L ED that emits light through the blood components exiting drum 214 and a photodetector that receives light after the light has passed through the components.

It is important to note that during processing, the osmotic pressure of the red blood cells prevents the anticoagulant introduced into the whole blood from entering/remaining with the red blood cells (e.g., within drum 214). Instead, the anticoagulant is mixed with the plasma constituent. Thus, the anticoagulant exits the drum 214 with the plasma and is collected with the plasma in the collection container 216. In other words, the product weight measured by the weight sensor 195 is the weight of the plasma and any anticoagulant mixed with the plasma, i.e., the weight provided by the weight sensor 195 is not the weight of pure plasma.

In addition, whole blood contains variable amounts of plasma, depending on the hematocrit of the donor. The hematocrit of a typical donor can vary between 38% and 54%, meaning that the volume of plasma can vary between 36ml and 62ml for 100ml of whole blood. Furthermore, the amount of anticoagulant added to the drawn whole blood is fixed (e.g., it is not dependent on the donor hematocrit), which means that the percentage of anticoagulant in the collected plasma can vary between 9.7% and 12.7% for donor hematocrit of 38% to 54%, respectively. Thus, not only the volume measured by the weight sensor 195 includes the volume of anticoagulant, but the volume of anticoagulant can vary from donor to donor based on hematocrit.

As described above, some embodiments of the present invention continue the blood processing/separation procedure until a target volume of pure plasma (e.g., only plasma (the volume of any anticoagulant that is not mixed with plasma in the target volume) is collected within the plasma collection container 216. to this end, some embodiments of the present invention may calculate the volume of pure plasma within the plasma collection container 216. for example, a technician or system 100 (e.g., a controller) may 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 into the whole blood and the donor's hematocrit (step 455.) the technician and/or system may 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, because the osmotic pressure of the red blood cells prevents anticoagulant from mixing therewith, substantially all of the anticoagulant exits the bowl 214 and is collected with the plasma in the plasma collection container 216.

The amount of anticoagulant added to the system 100 may be determined in a number of ways. For example, the system 100 may establish an amount of anticoagulant (e.g., a value of "AC" in the above equation) based on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood. In some embodiments, the value of "AC" may be the inverse of the predetermined ratio (e.g., if the ratio of anticoagulant to anticoagulated whole blood is 1:16, then "AC" would be 16). Additionally or alternatively, the technician/system 100 can monitor the amount of anticoagulant added to the system. In such embodiments, the technician/system may 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 changes in the weight of anticoagulant container 210 as measured by a weight sensor (discussed in more detail below).

Once the technician/system 100 has calculated the percentage of anticoagulant within the plasma collection container 216, the technician/system 100 may use this information to calculate the volume of pure plasma within the plasma collection container 216 (step 465). for example, the technician/system 100 may determine the volume of anticoagulant in the container (based on the percentage of anticoagulant within the container 216) and subtract that volume from the total volume of fluid within the container 216 as measured by the weight sensor 195. the system 100 may continue to monitor the volume of pure plasma collected within the container 216 and continue to process whole blood (e.g., continue to perform

steps

425, 430, 435, 440, 455, 460, and 465) until a target volume of pure plasma is collected within the plasma collection container 216 (step 470) (e.g., 800m L or other limits specified by the FDA or similar regulatory agency for an adult donor weighing over 175 pounds).

Once the system 100 has collected the target volume of pure plasma in the plasma collection container 216, the system 100 may return the remaining components (e.g., the components remaining within the drum 214) to the subject (step 475). For example, when all of the plasma is removed and the drum 214 is full of RBCs (and any other blood components not collected), the controller 226 stops drawing whole blood from the subject and reverses the direction of the blood/first pump 232 to draw RBCs (and other components) directly from the drum 214 back to the subject. Alternatively, if the system 100 is so equipped with a dedicated return line, the system may return the components to the subject via the dedicated return line.

In addition to the uncollected blood components (e.g., components remaining in drum 214), system 100 may also return saline to the patient/subject. Saline may be used as a compensation fluid to compensate for the volume of blood components (e.g., plasma) that are withdrawn and collected and not returned to the patient. To this end, during a return step (e.g., step 475), the saline valve 135 may be opened to allow saline from the saline container 217 to flow through the saline line 223 and into the drum 214 (through outlet 224), where it may be returned to the patient/donor along with or after the remaining blood components.

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

Some embodiments may also (optionally) monitor the volume of anticoagulant remaining in drum 214 (step 460) (e.g., anticoagulant that is not mixed with plasma and/or otherwise remains in the drum). For example, the system 100 may utilize an optical sensor on the drum 214 to determine whether any anticoagulant remains within the drum 214. If so, the method 400/system 100 may modify the calculation of the amount of pure plasma collected in the plasma collection container (e.g., increase the calculated amount or decrease the calculated amount) based on the volume of anticoagulant remaining in the drum 214.

The various embodiments of the present invention described above provide a number of benefits compared to prior art plasma collection systems. In particular, as described above, prior art plasmapheresis devices end plasma collection based on the total volume of anticoagulated plasma (e.g., pure plasma plus added anticoagulant). Although this is the simplest method, as it only requires weighing the product collection container, the amount of authentic product (pure plasma) depends on the donor's hematocrit. In other words, due to the variation in the anticoagulant percentage in the product, the prior art system will collect more plasma from a low hematocrit donor than from a high hematocrit donor. Various embodiments of the present invention solve the problems of prior art systems by collecting a standard volume (e.g., target volume) of pure plasma from each donor. As described above, embodiments of the present invention accomplish this by using the donor's hematocrit and the amount of anticoagulant collected within the plasma collection container 216 (e.g., by counting the revolutions of the pump and/or using a scale/weight sensor, etc.) to determine the percentage of anticoagulant in the product. In addition, by stopping the plasma collection process based on the volume of pure plasma collected, embodiments of the present invention are able to collect a larger volume of plasma than prior art systems that stop based on a plasma/anticoagulant mixture.

Fig. 5 shows another method of collecting plasma using the system shown in fig. 1-3 (or a similar system) that establishes a total volume of plasma to be collected based on an individual donor (e.g., based on his height, weight, hematocrit blood volume, and/or plasma volume). In a similar manner as described above for the method shown in fig. 4, the system/method may acquire/determine some information about the donor, i.e., the weight and height of the donor (step 505) and hematocrit (step 510), before connecting the donor to the blood processing apparatus 100. For example, a technician may obtain/determine the weight of a donor by weighing the donor (e.g., on a scale), and obtain the height of the donor by measuring the donor. To obtain/determine the donor's hematocrit (e.g., in a manner similar to that described above), a technician may use a hematocrit sensor and/or test a blood sample based on the volume of red blood cells collected within drum 214 or the system may use a hematocrit sensor during blood processing and/or determine the hematocrit based on the volume of red blood cells collected within drum 214.

Using the height and weight of the donor and the hematocrit, the system 100/method 500 can calculate the plasma volume of the donor (e.g., the volume of plasma within the donor's blood) (step 515). For example, the system 100/method 500 may use the height and weight of the donor to calculate a body mass index ("BMI") of the donor/subject (e.g., BMI ═ weight/height)²) The calculated BMI is then used to calculate the total Blood Volume in the donor/subject (see, e.g., L emmens et al, timing Blood Volume in Obese and morbid Obese Patents, obesitiy Surgery,2006:16, 773-:

in the above formula, InBV is the indexed blood volume (e.g., total blood volume of the donor) and BMip is the BMI of the patient (e.g., kg/m)²) 22 is the BMI value for Ideal Body Weight (IBW) (e.g., also in kg/m)²In units) and 70 is the donor at its ideal body weight (BMI 22 kg/m)²) Once the system 100 has calculated the total blood volume in the donor/subject, the system 100 (e.g., a controller) may then determine/calculate the plasma volume in the donor's blood based on, for example, the donor's hematocrit (step 515).

As described above, the embodiment shown in fig. 5 establishes the volume of plasma to be collected based on the individual donors. To this end, once the system 100/method 500 determines the donor's plasma volume, the system 100/method 500 may then calculate a target plasma volume to be collected (step 520). For example, the system 100/method 500 may multiply the total plasma volume in the patient by the target percentage of plasma to be collected to obtain the target plasma volume to be collected (e.g., 769.5ml if the total plasma volume is 2700ml and the target percentage to be collected is 28.5%). The target percentage of plasma to be collected may depend on the application and/or donor, and may be directly input into the system 100 (e.g., using the user interface 190), or may be preset by the factory. In some embodiments, the target percentage may be 26.5% to 30%, and preferably may be 28.5%. However, in other embodiments, the target percentage may be less than 26.5% or greater than 30%.

Once line 222/223 is in place and the system 100/method 500 has calculated the target plasma volume, the user/technician may insert the venous access device 206 into the arm 208 of the donor (step 525). Next, the controller 226 activates the two

pumps

232, 234 and the motor 228 in a similar manner as described above for the method shown in fig. 4. Operation of both

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 will be delivered to inlet end 220 of drum 214.

As anticoagulated whole blood is withdrawn from the subject and introduced into the blood component separation device 214, the blood component separation device 214 separates the whole blood into individual blood components (e.g., into plasma, platelets, RBCs, and possibly WBCs) (step 540). As described above, the higher density components (i.e., RBCs) are forced against the outer wall of the drum 214, and plasma is the component closest to the outlet end and thus the first fluid component that exits the drum 214 through the outlet end 224 as additional anticoagulated whole blood enters the drum 214 through the inlet end 220. During separation and processing, optical sensor 213 monitors each layer of blood components (as they are gradually and coaxially advanced from the outer wall to the center of drum 214) and may change and/or terminate the steps of drawing whole blood from the subject/donor and introducing the whole blood into drum 12 in response to detection. Additionally, as described above, the optical sensor 213 can be used to determine the donor's hematocrit during the treatment (e.g., if it is unknown and/or undetermined before the treatment is started).

Once the blood component separation device 214 separates the blood into its various components, the plasma may be moved through line 222 to a plasma container 216 (e.g., a plasma bottle) (step 545). As described 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) is collected within the plasma collection container 216. If line sensor 185 is provided, system 100 may then use the information from sensor 185 to stop blood components from being removed from drum 214, stop whole blood from being drawn from the subject, or redirect flow by, for example, closing one valve and opening another valve.

As described above, some embodiments of the present invention continue the blood processing/separation procedure until a target plasma collection volume is collected. To ensure that this volume does not include the volume of any anticoagulant collected within container 216, the target plasma collection volume should include only a volume of pure plasma (e.g., only plasma, i.e., a volume that does not include any anticoagulant mixed with plasma in the target volume). To this end, in a manner similar to that described above, some embodiments of the present invention may calculate the volume of pure plasma within the plasma collection container 216. To determine the volume of pure plasma, the technician or the system 100 (e.g., controller) may 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 hematocrit of the donor (step 560) (see the formula provided above). The amount of anticoagulant added to the system 100 may 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, etc.).

Once the technician/system 100 has calculated the percentage of anticoagulant within the plasma collection container 216, the technician/system 100 may use this information to calculate the volume of pure plasma within the plasma collection container 216 (step 570). For example, as described above, the technician/system 100 may determine the volume of anticoagulant in the container (based on the percentage of anticoagulant within the container 216) and subtract that volume from the total volume of fluid within the container 216 as measured by the weight sensor 195. The system 100 may continue to monitor the amount of pure plasma collected within the container 216 and continue to process the whole blood (e.g., continue to perform

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 individual plasma volume of the donor and the target percentage of plasma to be collected).

Once the system 100 has collected the target plasma volume within the plasma collection container 216, the system 100 may return the remaining components (e.g., components remaining within the drum 214) to the subject by stopping the drawing of whole blood from the subject and reversing the direction of the blood/first pump 232 to draw RBCs (and other components) from the drum 214 back to the subject (e.g., directly via the blood/inlet line 218 or via a dedicated return line if so equipped) (step 580).

It is important to note that because the system 100/method 500 collects and does not return some blood components (e.g., plasma), the volume of fluid returned to the donor/subject is less than the volume that has been removed. This in turn creates an intravascular deficit equal to the amount of plasma collected (e.g., the volume of whole blood removed from the donor minus the volume of collected/unreturned plasma). In the case of intravascular insufficiency, they risk syncope when the procedure is completed and the donor rises off the facility. As described above, to reduce intravascular insufficiency (and risk of donor injury), some embodiments of the invention return saline to the patient/subject (step 585). Saline may be used as a compensation fluid to compensate for the volume of blood component (e.g., plasma) removed. To do so, during the return step (e.g., step 580), the controller 226 (or technician) may open the saline valve to allow saline from the saline container 217 to flow through the saline line 223 and into the drum 214 (through the outlet 224), where it may be returned to the patient/donor along with or after the remaining blood components.

As described above, the volume of plasma collected from a donor varies from donor to donor (e.g., because the volume of plasma is based on the height, weight, hematocrit, and blood volume of the donor). Thus, the volume of saline returned to the donor to reduce intravascular insufficiency may similarly depend on the donor. To this end, when the contents of the separation device and saline are returned to the donor (steps 580 and 585), the system 100/method 500 may calculate an intravascular insufficiency based on the volume of blood components and saline that have been returned based on the total volume of whole blood removed from the donor (or based on the volume of plasma collected and the volume of blood components and saline that have been returned) (step 590). The system 100/method 500 may continue to return saline until the donor's intravascular insufficiency reaches the target intravascular insufficiency (step 595).

The target intravascular deficiency may be any intravascular deficiency that reduces the risk of donor syncope, and may be the same for each donor, for example, the target intravascular deficiency for each donor may be set to 0m L or 250m L, or, similar to the target plasma volume to be collected, the target intravascular deficiency for each donor may be different, in other words, for some donors the target intravascular deficiency may be set to 0m L and for other donors may be set to 250m L it should be noted that 0 and 250m L are provided as examples only and other embodiments may have a target intravascular deficiency of 0 to 250m L or greater than 250m L.

Like the method 400 shown in fig. 4, the method 500 may similarly perform some additional and optional steps to help determine the volume of pure plasma within the plasma collection container 216. For example, certain embodiments may monitor the anticoagulant container 210 for weight changes (e.g., as measured by a weight/load sensor on the anticoagulant container 210) (step 550). This measurement provides an indication of the volume of anticoagulant that has been added to the system 100 and may be used to help determine the percentage of anticoagulant within the plasma collection container 216. Additionally or alternatively, some embodiments may similarly monitor changes in the weight and/or volume of plasma and anticoagulant collected within the plasma collection container 216 (e.g., via the weight sensor 195) (step 555). This measurement may be used to calculate the total volume of pure plasma collected within the plasma collection container 216 (e.g., to obtain the total weight from which the calculated volume of anticoagulant was subtracted). In addition, some embodiments may also use an optical sensor on drum 214 to monitor the volume of anticoagulant remaining in drum 214 (step 565) (e.g., anticoagulant that is not mixed with the plasma and/or otherwise remaining in the drum) to determine if any anticoagulant remains within drum 214 and modify the calculation of the amount of pure plasma collected in the plasma collection container (e.g., increase the calculated amount or decrease the calculated amount) based on the volume of anticoagulant remaining in drum 214.

As described above, prior art systems for plasma collection that follow the current FDA nomogram collect a volume of plasma product (e.g., anticoagulant and plasma mixed together) based only on the weight of the donor-the same volume is collected from each donor of the same weight. However, the total blood volume and plasma volume of the two donors may differ greatly. For example, when comparing two donors (one obese and one non obese) in the same somatic recombination according to the FDA nomogram, an obese donor will actually have a lower blood volume than a non obese donor. Furthermore, donors with high hematocrit will have a lower plasma volume relative to the total plasma volume. In other words, since total blood volume and total plasma volume vary from donor to donor (even among donors of the same body weight), the percentage of plasma in the final collected donor may vary greatly from donor to donor. By customizing the plasma collection for donors (e.g., based on the height, weight, BMI, hematocrit, total blood fluid volume, and/or total plasma volume of the donor) and collecting a predetermined percentage of plasma from each donor, embodiments of the present invention are able to collect a greater volume of plasma (e.g., pure plasma) from some donors, while collecting a lesser volume of plasma from more fragile donors (e.g., donors with high hematocrit, donors with lower plasma volume, etc.) than systems that do not establish a collection volume based on individual donors.

Similarly, current systems do not customize the saline return volume for the patient (e.g., each donor at a given level receives the same volume of saline, e.g., if the target plasma product volume is 800m L, the donor will receive 500m L saline.) however, because 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 thus the volume taken from the donor) varies based on the donor's hematocrit, the intravascular deficiencies of each donor will differ.

It is also important to note that while the various embodiments discussed above are related to a blood processing system that collects plasma, the features discussed herein may be applied to any type of blood processing system. For example, the features described herein may be implemented on a blood processing system that collects and/or processes red blood cells, platelets, and/or white blood cells.

The embodiments of the invention described above are intended to be exemplary only; many variations and modifications will be apparent to those of ordinary skill in the art. All such variations and modifications are intended to fall within the scope of the present invention as defined in any appended claims.

Claims

1. A method for collecting plasma, comprising:

(a) determining the weight and height of the donor;

(b) determining the hematocrit of the donor;

(c) calculating a donor plasma volume based at least in part on the weight and height of the donor and the hematocrit of the donor;

(d) calculating a target plasma collection volume based at least in part on the calculated donor plasma volume and the target percentage of plasma;

(e) drawing whole blood from a donor through a venous-access device and a first line, wherein the first line is connected to a blood component separation device;

(f) introducing anticoagulant into the drawn whole blood through an anticoagulant line;

(g) separating the drawn whole blood into a plasma component and at least a second blood component using a blood component separation device;

(h) collecting the plasma component from the blood component separation device into a plasma collection container;

(i) calculating the volume of pure plasma collected in the plasma collection container; and

(j) continuing to perform steps (e) through (i) until the calculated amount of pure plasma collected in the plasma collection container equals the target plasma collection amount.

2. The method of claim 1, further comprising:

after collecting at least a portion of the target plasma collection volume, the contents of the blood component separation device are returned to the donor via the first line.

3. The method of claim 2, further comprising:

the intravascular insufficiency is calculated 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.

4. The method of claim 3, further comprising:

a volume of saline is returned to the donor to obtain the target intravascular insufficiency.

5. The method of claim 4, wherein the target intravascular deficiency is 0 milliliters.

6. The method of claim 4, wherein the target intravascular deficiency is-250 to 500 milliliters.

7. The method of claim 1, further comprising:

a body mass index of the donor is calculated based at least in part on the weight and height of the donor, and a donor plasma volume is calculated based at least in part on the body mass index of the donor.

8. The method of claim 1, wherein the target percentage of plasma is 26.5% to 29.5% of the donor plasma volume.

9. The method of claim 1, further comprising:

prior to step (e), inserting the venous access device into the donor.

10. The method of claim 1, further comprising:

calculating a percentage of anticoagulant in the collected plasma component, and calculating a volume of pure plasma based at least in part on the calculated percentage of anticoagulant in the collected plasma component.

11. The method of claim 10, further comprising:

determining a volume change in the anticoagulant container, the calculated percentage of anticoagulant in the collected plasma based at least in part on the volume change in the anticoagulant container.

12. The method of claim 10, further comprising:

the volume of anticoagulant introduced into the whole blood is determined based on the number of revolutions of the anticoagulant pump, and the calculated percentage of anticoagulant in the collected plasma is based at least in part on the number of revolutions of the anticoagulant pump.

13. The method of claim 10, further comprising:

determining a volume of anticoagulant in the blood component separation device, the calculated percentage of anticoagulant in the collected plasma based at least in part on the volume of anticoagulant in the blood component separation device.

14. A method according to claim 10, wherein the percentage of anticoagulant in the collected plasma constituent comprises 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 filling step.

15. The method of claim 1, further comprising:

the volume of the plasma constituent collected in the plasma collection container is monitored, and the calculated volume of pure plasma collected in the plasma collection device is based at least in part on the monitored volume of the collected plasma constituent.

16. The method of claim 1, further comprising:

the weight of the plasma constituent collected in the plasma collection container is monitored, and the calculated volume of pure plasma collected in the plasma collection device is based at least in part on the monitored weight of the collected plasma constituent.

17. A method according to claim 1, wherein step (b) comprises monitoring the volume of red blood cells collected in the blood separation device, the determined donor hematocrit being 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.

18. A system for collecting plasma, comprising:

a venous access device for drawing whole blood from a subject and returning blood components to the subject;

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 being configured to deliver the plasma component to a plasma container;

a first line fluidly connected to the venous-access device and configured to convey the drawn whole blood to the blood component separation device and return fluid in the blood component separation device to the subject, flow through the first line 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 centrifugal drum and the first pump, the controller configured to: (1) calculating a donor plasma volume based at least in part on the weight and height of the donor and the hematocrit of the donor, (2) calculating a target plasma collection volume based at least in part on the calculated donor plasma volume and the target percentage of plasma, and (3) calculating a volume of pure plasma collected in the plasma container based at least in part on the percentage of anticoagulant in the collected plasma constituent, the controller configured to stop the first pump when the calculated volume of pure plasma collected in the plasma collection container equals the target plasma collection volume.

19. The system of claim 18, wherein the controller is further configured to:

after collecting at least a portion of the target plasma collection volume, fluid remaining in the blood component separation device is returned through the first line.

20. The system of claim 19, wherein the controller is further configured to:

21. The system of claim 20, further comprising:

a saline line configured to be fluidly connected to a saline source and the blood component separation device, the controller configured to return a volume of saline to the donor to obtain the target intravascular deficiency.

22. The system of claim 21, wherein the target intravascular deficiency is-250 to 500 milliliters.

23. The system of claim 18, wherein the controller is further configured to:

24. The system of claim 18, wherein the target percentage of plasma is 26.5% to 29.5% of the volume of donor plasma.

25. The system of claim 18, wherein the controller is further configured to:

the percent anticoagulant in the collected plasma fractions was calculated.

26. A system according to claim 25, wherein the percentage 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 hematocrit of the subject.

27. The system of claim 25, further comprising:

an anticoagulant source weight sensor configured to measure a weight of the anticoagulant source, the controller further configured to monitor a volume change in the anticoagulant container based on the measured weight of the anticoagulant source, the calculated percentage of anticoagulant in the collected plasma based at least in part on the volume change in the anticoagulant source.

28. The system of claim 25, wherein the controller is configured to monitor a rotation number of the anticoagulant pump to determine a volume of anticoagulant introduced into the whole blood, the calculated percentage of anticoagulant in the collected plasma based at least in part on the rotation number of the anticoagulant pump.

29. The system of claim 25, further comprising:

an optical sensor on the blood component separation device configured to 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 being based at least in part on the volume of anticoagulant in the blood component separation device.

30. The system of claim 18, further comprising:

a plasma container weight sensor configured to monitor a volume of plasma constituent collected in the plasma container, the calculated volume of pure plasma collected in the plasma collection device based at least in part on the monitored volume of plasma constituent collected.

31. The system of claim 18, further comprising:

a plasma container weight sensor configured to monitor a weight of the plasma constituent collected in the plasma container, the calculated volume of pure plasma collected in the plasma collection device based at least in part on the monitored weight of the collected plasma constituent.

32. The system of claim 18, further comprising:

an optical sensor located on the blood component separation device and configured to monitor a volume of red blood cells collected in the blood component separation device, the controller configured to determine a hematocrit of the subject based at least in part on the monitored volume of red blood cells collected in the blood component separation device and a volume of whole blood drawn from the donor.